English — authority Annex to Article 4

Official code: A.0001. Product type: Phencyclidine test system. Official classification: Class 2. Phencyclidine test system is a device to measure the concentration of Phencyclidine (an anesthetic agent) or Phencyclidine analog in blood, urine, or/andstomach contents. This device is to monitor the concentration of Phencyclidine or Phencyclidine analog in diagnosis or diseases treatment in order to ensure the suitability of the treatment.

Official code: A.0002. Product type: Clinical Chemistry Electrolyte System. Official classification: Class 1. Clinical chemistry electrolyte system is intended to perform a specific ion test system (e.g.,sodium and potassium test systems) that is used for the qualitative and/or quantitatively measurement of specific ion concentrations in serum, plasma and urine.

Official code: A.1020. Product type: Acid phosphatase (total or prostatic) test system. Official classification: Class 2. An acid phosphatase (total or prostatic) test system is a device intended to measure the activity of the acid phosphatase enzyme in plasma and serum.

Official code: A.1025. Product type: Adrenocorticotropic hormone (ACTH) test system. Official classification: Class 2. An adrenocorticotropic hormone (ACTH) test system is a device intended to measure adrenocorticotropic hormone in plasma and serum. ACTH measurements are used in the differential diagnosis and treatment of certain disorders of the adrenal glands suchas Cushing's syndrome, adrenocortical insufficiency, and the ectopic ACTH syndrome.

Official code: A.1030. Product type: Alanine amino transferase (ALT/SGPT) test system. Official classification: Class 1. An alanine amino transferase (ALT/SGPT) test system is a device intended to measure the activity of the enzyme alanine amino transferase (ALT) (also known as a serum glutamic pyruvic transaminase or SGPT) in serum and plasma. Alanine amino transferase measurements are used in the diagnosis and treatment of certain liver diseases (e.g., viral hepatitis and cirrhosis) and heart diseases.

Official code: A.1035. Product type: Albumin test system. Official classification: Class 2. An albumin test system is a device intended to measure the albumin concentration in serum and plasma. Albumin measurements are used in the diagnosis and treatment of numerous diseases involving primarily the liver or kidneys.

Official code: A.1040. Product type: Aldolase test system. Official classification: Class 1. An aldolase test system is a device intended to measure the activity of the enzyme aldolase in serum or plasma. Aldolase measurements are used in the diagnosis and treatment of the early stages of acute hepatitis and for certain muscle diseases such as progressive Duchenne-type muscular dystrophy.

Official code: A.1045. Product type: Aldosterone test system. Official classification: Class 2. An aldosterone test system is a device designed for the measurement of aldosterone hormone concentrations in serum and urine. Aldosteronemeasurements are used in the diagnosis and treatment of primary aldosteronism (a disorder caused by the excessive secretion of aldosterone by the adrenal gland), hypertension caused by primary aldosteronism, selective hypoaldosteronism, edematous states, and other conditions of electrolyte imbalance.

Official code: A.1050. Product type: Alkaline phosphatase or isoenzymes test system. Official classification: Class 2. An alkaline phosphatase or isoenzymes test system is a device intended to measure alkaline phosphatase or its isoenzymes (a group of enzymes with similarbiological activity) in serum or plasma. Measurements of alkaline phosphatase or its isoenzymes are used in the diagnosis and treatment of liver, bone, parathyroid, and intestinal diseases. Annex

Official code: A.1055. Product type: Newborn screening test system for amino acids, free carnitine, and acylcarnitines using tandem mass spectrometry. Official classification: Class 2. A newborn screening test system for amino acids, free carnitine, and acylcarnitines using tandem mass spectrometry is a device that consists of stable isotope internal standards, control materials,extraction solutions, flow solvents, instrumentation, software packages, and other reagents and materials. The device is intended for the measurement and evaluation of amino acids, free carnitine, and acylcarnitine concentrations from newborn whole bloodfilter paper samples. The quantitative analysis of amino acids, free carnitine, and acylcarnitines and their relationship with each other provides analyte concentration profiles thatmay aid in screening newborns for one or more inborn errors of amino acid, free carnitine, and acyl-carnitine metabolism.

Official code: A.1060. Product type: Delta-aminolevulinic acid test system. Official classification: Class 1. A delta -aminolevulinic acid test system is a device intended to measure the level of delta-aminolevulinic acid (a precursor of porphyrin) in urine. Delta-aminolevulinic acid measurements are used in the diagnosis and treatment of lead poisoning and certain porphyrias (diseases affecting the liver, gastrointestinal, and nervous systems that are accompanied by increased urinary excretion of various heme compounds including delta-aminolevulinic acid).

Official code: A.1065. Product type: Ammonia test system. Official classification: Class 1. An ammonia test system is a device intended to measure ammonia levels in blood, serum, and plasma, Ammonia measurements are used in the diagnosis and treatment of severe liver disorders, such as cirrhosis, hepatitis, and Reye's syndrome.

Official code: A.1070. Product type: Amylase test system. Official classification: Class 2. An amylase test system is a device intended to measure the activity of the enzyme amylase in serum and urine. Amylase measurements are used primarily for the diagnosis and treatment of pancreatitis (inflammation of the pancreas).

Official code: A.1075. Product type: Androstenedione test system. Official classification: Class 1. An androstenedione test system is a device intended to measure androstenedione (a substance secreted by the testes, ovary, and adrenal glands) in serum. Androstenedione measurements are used in the diagnosis and treatment of females with excessive levels of androgen (male sex hormone) production.

Official code: A.1080. Product type: Androsterone test system. Official classification: Class 1. An androsterone test system is a device intended to measure the hormone androsterone in serum, plasma, and urine. Androsterone measurements are used in the diagnosis and treatment of gonadal and adrenal diseases.

Official code: A.1085. Product type: Angiotensin I and renin test system. Official classification: Class 2. An angiotensin I and renin test system is a device intended to measure the level ofangiotensin I generated by renin in plasma. Angiotensin I measurements are used in the diagnosis and treatment of certain types of hypertension.

Official code: A.1090. Product type: Angiotensin converting enzyme (A.C.E) test system. Official classification: Class 2. An angiotensin converting enzyme (A.C.E.) test system is a device intended to measure the activity of angiotensin converting enzyme in serum and plasma. Measurements obtained by this device are used in the diagnosis and treatment of diseases such as sarcoidosis, a disease characterized by the formation ofnodules in the lungs, bones, and skin, and Gaucher's disease, a hereditary disorder affecting the spleen.

Official code: A.1095. Product type: Ascorbic acid test system. Official classification: Class 1. An ascorbic acid test system is a device intended to measure the level of ascorbic acid (vitamin C) in plasma, serum, and urine. Ascorbic acid measurements are used in the diagnosis and treatment of ascorbic acid dietary deficiencies.

Official code: A.1100. Product type: Asparate amino transferase (AST/SGOT) test system. Official classification: Class 2. An aspartate amino transferase (AST/SGOT) test system is a device intendedto measure the activity of the enzyme aspartate amino transferase (AST) (also known as a serum glutamic oxaloacetic transferase or SGOT) in serum and plasma. Aspartate amino transferase measurements are used in the diagnosis and treatment of certain types of liver and heart disease.

Official code: A.1110. Product type: Bilirubin (total or direct). Official classification: Class 2. A bilirubin (total or direct) test system is a device intended to measure the levels of bilirubin (total or direct) in plasmaor serum. test systemMeasurements of the levels of bilirubin,an organic compound formed during the normal and abnormal distruction of red blood cells, if used in the diagnosis and treatment of liver, hemolytic hematological, and metabolic disorders, including hepatitisand gall bladder block.

Official code: A.1113. Product type: Bilirubin (total and unbound) in the neonate test system. Official classification: Class 1. A bilirubin (total and unbound) in the neonate test system is a device intended to measure the levels of bilirubin (total andunbound) in the blood (serum) of newborn infants to aid in indicating the risk of bilirubin encephalopathy (kernicterus).

Official code: A.1115. Product type: Urinary bilirubin and its conjugates (nonquantitative) test system. Official classification: Class 1. A urinary bilirubin and its conjugates (nonquantitative) test system is a device intended to measure the levels of bilirubinconjugates in urine. Measurements of urinary bilirubin and its conjugates (nonquantitative) are used in the diagnosis and treatment of certain liver diseases.

Official code: A.1117. Product type: B-type natriuretic peptide test system. Official classification: Class 2. The B-type natriuretic peptide (BNP) test system is an in vitro diagnostic device intended to measure BNP in whole blood and plasma. Measurements of BNP are used as an aid in the diagnosis of patients with congestive heart failure.

Official code: A.1118. Product type: Biotinidase test system. Official classification: Class 2. The biotinidase test system is an in vitro diagnostic device intended to measure the activity of the enzyme biotinidase in blood. Measurements of biotinidase are used in the treatment and diagnosis of biotinidase deficiency, an inborn error of metabolismin infants, characterized by the inability to utilize dietary protein bound vitamin or to recycle endogenous biotin. The deficiency may result in irreversible neurological impairment.

Official code: A.1120. Product type: Blood gases (PCO 2 , PO 2 ) and blood pH test system. Official classification: Class 2. A blood gases (PCO 2 , PO 2 ) and blood pH test system is a device intended to measure certain gases in blood, serum, plasma or pH of blood, serum, and plasma. Measurements of blood gases ( PCO 2 , PO 2 ) and blood pH are used in the diagnosis and treatment of life-threatening acid-base disturbances.

Official code: A.1130. Product type: Blood volume test system. Official classification: Class 1. A blood volume test system is a device intended to measure the circulating blood volume. Blood volume measurements are used in the diagnosis and treatment of shock, hemorrhage, and polycythemia vera (a disease characterized by an absolute increase in erythrocyte mass and total blood volume).

Official code: A.1135. Product type: C-peptides of proinsulin test system. Official classification: Class 1. A C-peptides of proinsulin test system is a device intended to measure C-peptides of proinsulin levels in serum, plasma, and urine. Measurements of C-peptides of proinsulin are used in the diagnosis and treatment of patients with abnormal insulin secretion, including diabetes mellitus.

Official code: A.1140. Product type: Calcitonin test system. Official classification: Class 2. A calcitonin test system is a device intended to measure the thyroid hormone calcitonin (thyrocalcitonin) levels in plasma and serum. Calcitonin measurements are used in the diagnosis and treatment of diseases involving the thyroid and parathyroid glands, including carcinoma and hyperparathyroidism (excessive activity of the parathyroid gland).

Official code: A.1145. Product type: Calcium test system. Official classification: Class 2. A calcium test system is a device intended to measure the total calcium level in serum. Calcium measurements are used in the diagnosis and treatment of parathyroid disease, a variety of bone diseases, chronic renal disease and tetany (intermittent muscular contractions or spasms).

Official code: A.1150. Product type: Calibrator. Official classification: Class 2. A calibrator is a device intended for medical purposes for use in a test system to establish points of reference that are used in the determination of values in the measurement of substances in human specimens.

Official code: A.1155. Product type: Human chorionic gonadotropin (HCG) test system. Official classification: Class 2,3. (a)Human chorionic gonadotropin (HCG) test system intended for the early detection of pregnancy--(1)Identification: A human chorionic gonadotropin (HCG) test system is a device intended for the early detection of pregnancy is intended to measure HCG, a placental hormone, in plasma or urine. (2)Classification: Class 2. (b)Human chorionic gonadotropin (HCG) test system intended for any uses other than early detection of pregnancy -- (1)Identification: A human chorionic goadotropin (HCG) test system is a device intended for any uses other than early detection of pregnancy (such as an aid in the diagnosis, prognosis, and management of treatment of persons with certain tumors or carcinomas) is intended to measure HCG, a placental hormone, in plasma or urine.(2)Classification: Class 3.

Official code: A.1160. Product type: Bicarbonate/carbon dioxide test system. Official classification: Class 2. A bicarbonate/carbon dioxide test system is a device intended to measure bicarbonate/carbon dioxide in plasma, serum, and whole blood. Bicarbonate/carbon dioxide measurements are used in the diagnosis and treatment of numerous potentially serious disorders associated with changes in body acid-base balance.

Official code: A.1163. Product type: Cardiac allograft gene expression profiling test system. Official classification: Class 2. A cardiac allograft gene expression profiling test system is a device that measures the ribonucleic acid (RNA) expression level of multiple genes and combines this information to yield a signature (pattern, classifier, index, score) to aid inthe identification of a low probability of acute cellular rejection (ACR) in heart transplant recipients with stable allograft function.

Official code: A.1165. Product type: Catecholamines (total) test system. Official classification: Class 1. A catecholamines (total) test system is a device intended to determine whether a group of similar compounds (epinephrine, norepinephrine, and dopamine) are present in urine and plasma. Catecholamine determinations are used in the diagnosis and treatment of adrenal medulla and hypertensive disorders, and for catecholamine-secreting tumors (pheochromocytoma, neuroblastoma, ganglioneuroma, and retinoblastoma).

Official code: A.1170. Product type: Chloride test system. Official classification: Class 2. A chloride test system is a device intended to measure the level of chloride in plasma, serum, sweat, and urine. Chloride measurements are usedin the diagnosis and treatment of electrolyte and metabolic disorders such as cystic fibrosis and diabetic acidosis.

Official code: A.1175. Product type: Cholesterol (total) test system. Official classification: Class 1. A cholesterol (total) test system is a device intended to measure cholesterol in plasma and serum. Cholesterol measurements are used in the diagnosis and treatment of disorders involving excess cholesterol in the blood and lipid and lipoprotein metabolism disorders.

Official code: A.1177. Product type: Cholylglycine test system. Official classification: Class 2. A cholylglycine test system is a device intended to measure the bile acid cholylglycine in serum. Measurements obtained by this device are used in the diagnosis and treatment of liver disorders, such as cirrhosis or obstructive liver disease.

Official code: A.1180. Product type: Chymotrypsin test system. Official classification: Class 1. A chymotrypsin test system is a device intended to measure the activity of the enzyme chymotrypsin in blood and other body fluids and in feces. Chymotrypsin measurements are used in the diagnosis and treatment of pancreatic exocrine insufficiency.

Official code: A.1185. Product type: Compound S (11- deoxycortisol) test system. Official classification: Class 1. A compound S (11-dioxycortisol) test system is a device intended to measure the level of compound S (11-dioxycortisol) in plasma. Compound S is a steroid intermediate in the biosynthesis of the adrenal hormone cortisol. Measurements of compound S are used in the diagnosis and treatment of certain adrenal and pituitary gland disorders resulting in clinical symptoms of masculinization and hypertension.

Official code: A.1187. Product type: Conjugated sulfolithocholic acid (SLCG) test system. Official classification: Class 2. A conjugated sulfolithocholicacid (SLCG) test system is a device intended to measure the bile acid SLCG in serum. Measurements obtained by this device are used in the diagnosis and treatment of liver disorders, such as cirrhosis or obstructive liver disease.

Official code: A.1190. Product type: Copper test system. Official classification: Class 1. A copper test system is a device intended to measure copper levels in plasma, serum, and urine. Measurements of copper are used in the diagnosis and treatment of anemia, infections, inflammations, and Wilson's disease (a hereditary disease primarily ofthe liver and nervous system). Test results are also used in monitoring patients with Hodgkin's disease (a disease primarily of the lymph system).

Official code: A.1195. Product type: Corticoids test system. Official classification: Class 1. A corticoids test system is a device intended to measure the levels of corticoids (hormones of the adrenal cortex) in serum and plasma. Measurements of corticoids are used in the diagnosis and treatment of disorders of the cortex of the adrenal glands, especially those associated with hypertension and electrolyte disturbances.

Official code: A.1200. Product type: Corticosterone test system. Official classification: Class 1. A corticosterone test system is a device intended to measure corticosterone (a steroid secreted by the adrenal gland) levelsin plasma. Measurements of corticosterone are used in the diagnosis and treatment of adrenal disorders such as adrenal cortex disorders and blocks in cortisol synthesis.

Official code: A.1205. Product type: Cortisol (hydrocortisone and hydroxycorticosterone) test system. Official classification: Class 2. A cortisol (hydrocortisone and hydroxycorticosterone) test system is a device intended to measure the cortisol hormones secreted by the adrenal gland in plasma and urine. Measurements of cortisol are used in the diagnosis and treatment of disorders of the adrenal gland.

Official code: A.1210. Product type: Creatine test system. Official classification: Class 1. A creatine test system is a device intended to measure creatine(a substance synthesized in the liver and pancreas and found in biological fluids) in plasma, serum, and urine. Measurements of creatine are used in the diagnosis and treatment of muscle diseases and endocrine disorders including hyperthyroidism.

Official code: A.1215. Product type: Creatine phosphokinase/ creatine kinase or isoenzymes test system. Official classification: Class 2. A creatine phosphokinase/creatine kinase or isoenzymes test system is a device intended to measure the activity of the enzyme creatine phosphokinase or its isoenzymes (a group of enzymes with similar biological activity) in plasma and serum. Measurements of creatine phosphokinase and its isoenzymes are used in the diagnosis and treatment of myocardial infarction and muscle diseases such as progressive, Duchenne-type muscular dystrophy.

Official code: A.1220. Product type: Acute Kidney Injury Test System. Official classification: Class 2. An acute kidney injury test system is a device that is intended to measure one or more analytes in human samples as an aid inthe assessment of a patient's risk for developing acute kidney injury. Test results are intended to be used in conjunction with other clinical and diagnostic findings, consistent with professional standards of practice, including confirmation by alternative methods.

Official code: A.1225. Product type: Creatinine test system. Official classification: Class 2. A creatinine test system is a device intended tomeasure creatinine levels in plasma and urine. Creatinine measurements are used in the diagnosis and treatment of renal diseases, in monitoring renal dialysis, and as a calculation basis for measuring other urine analytes.

Official code: A.1230. Product type: Cyclic AMP test system. Official classification: Class 2. A cyclic AMP test system is a device intended to measure the level of adenosine 3', 5'-monophosphate (cyclic AMP) in plasma, urine, and other body fluids. Cyclic AMP measurements are used in the diagnosis and treatment of endocrine disorders, including hyperparathyroidism (overactivity of the parathyroid gland). Cyclic AMP measurements may also be used in the diagnosis and treatment of Graves' disease (a disorder of the thyroid) and in the differentiation of causes of hypercalcemia (elevated levels of serum calcium.)

Official code: A.1235. Product type: Cyclosporine test system. Official classification: Class 2. A cyclosporine test system is a device intended to quantitatively determine cyclosporine concentrations as an aid in the management of transplant patients receiving therapy with this drug. This generic type ofdevice includes immunoassays and chromatographic assays for cyclosporine.

Official code: A.1240. Product type: Cystine test system. Official classification: Class 1. A cystine test system is a device intended to measure the amino acid cystine in urine. Cystine measurements are used in the diagnosis of cystinuria (occurrence of cystine in urine). Patients with cystinuria frequently develop kidney calculi (stones).

Official code: A.1245. Product type: Dehydroepiandrosterone (free and sulfate) test system. Official classification: Class 1. A dehydroepiandrosterone (free and sulfate) test system is a device intended to measure dehydroepiandrosterone (DHEA) and its sulfate in urine, serum, plasma, and amniotic fluid. Dehydroepiandrosterone measurements are used in the diagnosis and treatment of DHEA-secreting adrenal carcinomas.

Official code: A.1250. Product type: Desoxycorticosterone test system. Official classification: Class 1. A desoxycorticosterone test system is a device intended to measure desoxycorticosterone (DOC) in plasma and urine. DOC measurements are used in the diagnosis and treatment of patients with hypermineralocorticoidism (excess retention of sodium and loss of potassium) and other disorders of the adrenal gland. A.12552,3-Diphosphoglyceric acid test system 1A 2,3-diphosphoglyceric acid test system is a device intended to measure 2,3-diphosphoglyceric acid (2,3-DPG) in erythrocytes (red blood cells). Measurements of 2,3-diphosphoglyceric acid are used in the diagnosis and treatment of blood disorders that affect the delivery of oxygen by erythrocytes to tissues and in monitoring the quality of stored blood.

Official code: A.1260. Product type: Estradiol test system. Official classification: Class 1. An estradiol test system is a device intended to measure estradiol, an estrogenic steroid, in plasma. Estradiol measurements are used in the diagnosis and treatment of various hormonal sexual disorders and in assessing placental function in complicated pregnancy.

Official code: A.1265. Product type: Estriol test system. Official classification: Class 1. An estriol test system is a device intended to measure estriol, an estrogenic steroid, in plasma, serum, and urine of pregnant females. Estriol measurements are used in the diagnosis and treatment of fetoplacental distress in certain cases of high-risk pregnancy.

Official code: A.1270. Product type: Estrogens (total, in pregnancy) test system. Official classification: Class 1. As estrogens (total, in pregnancy) test system is a device intended to measure total estrogens in plasma, serum, and urine during pregnancy. The device primarily measures estrone plus estradiol. Measurements of total estrogens are used to aid in the diagnosis and treatment of fetoplacental distress in certain cases of high-risk pregnancy.

Official code: A.1275. Product type: Estrogens (total, nonpregnancy) test system. Official classification: Class 1. As estrogens (total, nonpregnancy) test system is adevice intended to measure the level of estrogens (total estrone, estradiol, and estriol) in plasma, serum, and urine of males and nonpregnant females. Measurement of estrogens (total, nonpregnancy) is usedin the diagnosis and treatment of numerous disorders, including infertility, amenorrhea (absence of menses) differentiation of primary and secondary ovarian malfunction, estrogen secreting testicular and ovarian tumors, and precocious puberty in females.

Official code: A.1280. Product type: Estrone test system. Official classification: Class 1. An estrone test system is a device intended to measure estrone, an estrogenic steroid, in plasma. Estrone measurements are used in the diagnosis and treatment of numerous disorders, including infertility, amenorrhea, differentiation of primary and secondary ovarian malfunction, estrogen secreting testicular and ovarian tumors, and precocious puberty in females.

Official code: A.1285. Product type: Etiocholanolone test system. Official classification: Class 1. An etiocholanolone test system is a device intended to measure etiocholanolone in serum and urine. Etiocholanolone is a metabolic product of the hormone testosterone and is excreted in the urine. Etiocholanolone measurements are used in the diagnosis and treatment of disorders of the testes and ovaries.

Official code: A.1290. Product type: Fatty acids test system. Official classification: Class 1. A fatty acids test system is a device intendedto measure fatty acids in plasma and serum. Measurements of fatty acids are used in the diagnosis and treatment of various disorders of lipid metabolism.

Official code: A.1295. Product type: Folic acid test system. Official classification: Class 2. A folic acid test system is a device intended to measure the vitaminfolic acid in plasma and serum. Folic acid measurements are used in the diagnosis and treatment of megaloblastic anemia, which is characterized by the presence of megaloblasts (an abnormal red blood cell series) in the bone marrow.

Official code: A.1300. Product type: Follicle-stimulating hormone test system. Official classification: Class 1. A follicle-stimulating hormone test system is a device intended to measure follicle-stimulating hormone (FSH) in plasma, serum, and urine. FSH measurements are used in the diagnosis and treatment of pituitary gland and gonadal disorders.

Official code: A.1305. Product type: Formiminoglutamic acid (FIGLU) test system. Official classification: Class 1. A formiminoglutamic acid (FIGLU) test system is a device intended to measure formiminolutamic acid in urine. FIGLU measurements obtained by this device are used in the diagnosis of anemias, suchas pernicious anemia and congenital hemolytic anemia.

Official code: A.1310. Product type: Galactose test system. Official classification: Class 1. A galactose test system is a device intended to measure galactose in blood and urine. Galactose measurements are used in the diagnosis and treatment of the hereditary disease galactosemia (a disorder of galactose metabolism) in infants.

Official code: A.1315. Product type: Galactose-1-phosphate uridyl transferase test system. Official classification: Class 2. A galactose-1-phosphate uridyl transferase test system is a device intended to measure the activity of the enzyme galactose-1- phosphate uridyl transferase in erythrocytes (red blood cells). Measurements of galactose-1-phosphate uridyl transferase are used in the diagnosis and treatment of the hereditary disease galactosemia (disorder of galactose metabolism) in infants.

Official code: A.1320. Product type: Gastric acidity test system. Official classification: Class 1. A gastric acidity test system is a device intended to measure the acidity of gastric fluid. Measurements of gastric acidity are used in the diagnosis and treatment of patients with peptic ulcer, Zollinger-Ellison syndrome (peptic ulcer due to gastrin-secreting tumor of the pancreas), and related gastric disorders.

Official code: A.1325. Product type: Gastrin test system. Official classification: Class 1. A gastrin test system is a device intended to measure the hormone gastrin in plasma and serum. Measurements of gastrin are used in the diagnosis and treatment of patients with ulcers, pernicious anemia, and the Zollinger-Ellison syndrome (peptic ulcer due to a gastrin-secreting tumor of the pancreas).

Official code: A.1330. Product type: Globulin test system. Official classification: Class 1. A globulin test system is a device intended to measure globulins (proteins) in plasma and serum. Measurements of globulin are used in the diagnosis and treatment of patients with numerous illnesses including severe liver and renal disease, multiple myeloma, and other disorders of blood globulins.

Official code: A.1335. Product type: Glucagon test system. Official classification: Class 1. A glucagon test system is a device intended to measure the pancreatic hormone glucagon in plasma and serum. Glucagon measurements are used in the diagnosis and treatment of patients with various disorders of carbohydrate metabolism, including diabetes mellitus, hypoglycemia, and hyperglycemia.

Official code: A.1340. Product type: Urinary glucose (nonquantitative) test system. Official classification: Class 2. A urinary glucose (nonquantitative) test system is a device intended to measure glucosuria (glucose in urine). Urinary glucose (nonquantitative) measurements are used in the diagnosis and treatment of carbohydrate metabolism disorders including diabetes mellitus, hypoglycemia, and hyperglycemia.

Official code: A.1345. Product type: Glucose test system. Official classification: Class 2. A glucose test system is a device intended to measure glucose quantitatively in blood and other body fluids. Glucose measurements are used in the diagnosis and treatment of carbohydrate metabolism disordersincluding diabetes mellitus, neonatal hypoglycemia, and idiopathic hypoglycemia, and of pancreatic islet cell carcinoma.

Official code: A.1350. Product type: Continuous Glucose Monitor Secondary Display. Official classification: Class 2. A continuous glucose monitor secondary display is identified as a device intended to be used for passive real-time monitoring of continuous glucose monitoring data. It must not be capable of serving as a stand-alone primary display device. The primary display device, which is not a part of the continuous glucose monitor secondary display, directly receives the glucose data (for example, it communicates directly with transmitter) from the continuous glucosemeter, which is not a part of the continuous glucose monitor secondary display, and is the primary means of viewing the continuous glucose monitor data and alerting the patient to a lowor high glucose value. A continuous glucose monitor secondary displaycan be used by caregivers of people with diabetes to monitor a person's continuous glucose monitoring data. A device is not a continuous glucose monitor secondary display if the data from the primary display device is modified (for example, predicting future glucose values) or the patient can use the secondary display in lieu of a primary display device (for example, the primary display device is blinded or the primary display does not haveto be near the person wearing the sensor and transmitter).

Official code: A.1355. Product type: Integrated continuous glucose monitoring system. Official classification: Class 2,3. An integrated continuous glucose monitoring system (iCGM) is intended to automatically measure glucose in bodily fluids continuously or frequently for a specified period of time. Classification: (1) Class 2 devices are intended to be used alone for diabetes self-management. (2) Class 3 devices are intended to transmit glucose measurement data to automated insulin dosing systems, and to adjust insulin dose.

Official code: A.1358. Product type: Insulin therapy adjustment device. Official classification: Class 2. An insulin therapy adjustment device is a device intended to incorporate biological inputs, including glucose measurement data from a continuous glucose monitor, to recommend insulin therapy adjustments as an aid in optimizing insulin therapy regimens for patients with diabetes mellitus. The device must not be intended for use in implementing automated insulin dosing.

Official code: A.1360. Product type: Gamma-glutamyl transpeptidase and isoenzymes test system. Official classification: Class 1. A gamma-glutamyl transpeptidase and isoenzymes test system is a device intended to measure the activity of the enzyme gamma- glutamyl transpeptidase (GGTP) in plasma and serum. Gamma-glutamyl transpeptidase and isoenzymes measurements are used in the diagnosis and treatment of liver diseases such as alcoholic cirrhosis and primary and secondary liver tumors.

Official code: A.1365. Product type: Glutathione test system. Official classification: Class 1. A glutathione test system is a device intended to measure glutathione (the tripeptide of glycine, cysteine, and glutamic acid) in erythrocytes (red blood cells). Glutathione measurements are used in the diagnosis and treatment of certain drug-induced hemolytic (erythrocyte destroying) anemias due to an inherited enzyme deficiency.

Official code: A.1370. Product type: Human growth hormone test. Official classification: Class 1. A human growth hormone test system is a device intended to measure the levels of human growth hormone in plasma. Human systemgrowth hormone measurements are used in the diagnosis and treatment of disorders involving the anterior lobe of the pituitary gland.

Official code: A.1373. Product type: Hemoglobin A1c test system. Official classification: Class 2. A hemoglobin A1c test system is a device used to measure the percentage concentration of hemoglobin A1c in blood. Measurement of hemoglobin A1c is used as an aid in the diagnosis of diabetes mellitus and as an aid in the identification of patients atrisk for developing diabetes mellitus.

Official code: A.1375. Product type: Histidine test system. Official classification: Class 1. A histidine test system is a device intended to measure free histidine (an amino acid) in plasma and urine. Histidine measurements are used in the diagnosis and treatment of hereditary histidinemia characterized by excess histidine in the blood and urine often resulting in mental retardation and disordered speech development.

Official code: A.1377. Product type: Urinary homocystine (nonquantitative) test system. Official classification: Class 2. A urinary homocystine (nonquantitative) test system is a device intended to identify homocystine (ananalogue of the amino acid cystine) in urine. The identification of urinary homocystine is used in the diagnosis and treatment of homocystinuria (homosystine in urine), a heritable metabolic disorder which may cause mental retardation.

Official code: A.1380. Product type: Hydroxybutyric dehydrogenase test system. Official classification: Class 1. A hydroxybutyric dehydrogenase test system is a device intended to measure the activity of the enzyme alpha-hydroxybutyric dehydrogenase (HBD) in plasma or serum. HBD measurements are used in the diagnosis and treatment of myocardial infarction, renal damage (such as rejection of transplants), certain hematological diseases (such as acute leukemias and megaloblastic anemias) and, to a lesser degree, liver disease. A.138517-Hydroxycorticosteroids (17-ketogenic steroids) test system 1A 17-hydroxycorticosteroids (17-ketogenic steroids) test system is a device intended to measure corticosteroids that possess a dihydroxyacetone moiety on the steroid nucleus in urine. Corticosteroids with this chemical configuration include cortisol, cortisone 11-desoxycortisol, desoxycorticosterone, and their tetrahydroderivatives. This group of hormones is synthesized by the adrenal gland. Measurements of 17-hydroxycorticosteroids (17-ketogenic steroids) are used in the diagnosis and treatment of various diseases of the adrenal or pituitary glands and gonadal disorders. A.13905-Hydroxyindole acetic acid/serotonin test system 1 A 5-hydroxyindole acetic acid/serotonin test system is a device intended to measure 5-hydroxyindole acetic acid/serotonin in urine. Measurements of 5-hydroxyindole acetic acid/serotonin are used in the diagnosis and treatment of carcinoid tumors of endocrine tissue. A.139517-Hydroxyprogesterone test system 1A 17-hydroxyprogesterone test system is a device intended to measure 17-hydroxyprogesterone (a steroid) in plasma and serum. Measurements of 17-hydroxyprogesterone are used in the diagnosis and treatment of various disorders of the adrenal glands or the ovaries.

Official code: A.1400. Product type: Hydroxyproline test system. Official classification: Class 1. A hydroxyproline test system is a device intended to measure the amino acid hydroxyproline in urine. Hydroxyproline measurements are used in the diagnosis and treatment of various collagen (connective tissue) diseases, bone disease such as Paget's disease, and endocrine disorders such as hyperparathyroidism and hyperthyroidism.

Official code: A.1405. Product type: Immunoreactive insulin test. Official classification: Class 1. An immunoreactive insulin test system is a device intended to measure immunoreactive insulin in serum and plasma. systemImmunoreactive insulin measurements are used in the diagnosis and treatment of various carbohydrate metabolism disorders, including diabetes mellitus, and hypoglycemia.

Official code: A.1410. Product type: Iron (non-heme) test system. Official classification: Class 1. An iron (non-heme) test system is a device intended to measure iron (non-heme) in serum and plasma. Iron (non-heme) measurements are used in the diagnosis and treatment of diseases such as iron deficiency anemia, hemochromatosis (a disease associated with widespread deposit in the tissues of two iron-containing pigments, hemosiderin and hemofuscin, and characterized by pigmentation of the skin), and chronic renal disease.

Official code: A.1415. Product type: Iron-binding capacity test system. Official classification: Class 1. An iron-binding capacity test system is a device intended to measure iron-binding capacity in serum. Iron-binding capacity measurements are used in the diagnosis and treatment of anemia.

Official code: A.1420. Product type: Isocitric dehydrogenase test system. Official classification: Class 1. An isocitric dehydrogenase test system is a device intended to measure the activity of the enzyme isocitric dehydrogenase inserum and plasma. Isocitric dehydrogenase measurements are used in the diagnosis and treatment of liver disease such as viral hepatitis, cirrhosis, or acute inflammation of the biliary tract; pulmonary disease such as pulmonary infarction (local arrest or sudden insufficiency of the blood supply to the lungs), and diseases associated with pregnancy. A.143017-Ketosteroids test system1A 17-ketosteroids test system is a device intended to measure 17-ketosteroids in urine. Measurements of 17-ketosteroids are used in the diagnosis and treatment of disorders of the adrenal cortex and gonads and of other endocrine disorders, including hypertension, diabetes, and hypothyroidism.

Official code: A.1435. Product type: Ketones (nonquantitative) test system. Official classification: Class 1. A ketones (nonquantitative) test system is a device intended to identify ketones in urine and other body fluids. Identification of ketones is used in the diagnosis and treatment of acidosis (a condition characterized by abnormally high acidity of body fluids) or ketosis (a condition characterized by increased production ofketone bodies such as acetone) and for monitoring patients on ketogenic diets and patients with diabetes.

Official code: A.1440. Product type: Lactate dehydrogenase test system. Official classification: Class 1. A lactate dehydrogenase test system is a device intended to measure the activity of the enzyme lactate dehydrogenase in serum. Lactate dehydrogenase measurements are used in the diagnosis and treatment of liver diseases such as acute viral hepatitis, cirrhosis, and metastatic carcinoma of the liver, cardiac diseases such as myocardial infarction, and tumors of the lung or kidneys.

Official code: A.1445. Product type: Lactate dehydrogenase isoenzymes test system. Official classification: Class 2. A lactate dehydrogenase isoenzymes test system is a device intended to measure the activity of lactate dehydrogenase isoenzymes (a group of enzymes with similar biological activity) in serum. Measurements of lactate dehydrogenase isoenzymes are used in the diagnosis and treatment of liver diseases, such as viral hepatitis, and myocardial infarction.

Official code: A.1450. Product type: Lactic acid test system. Official classification: Class 1. A lactic acid test system is a device intended to measure lactic acid in whole blood and plasma. Lactic acid measurements that evaluate the acid-base status are used in the diagnosis and treatment of lactic acidosis (abnormally high acidity of the blood).

Official code: A.1455. Product type: Lecithin/sphingomyelin ratio in amniotic fluid test system. Official classification: Class 2. A lecithin/sphingomyelin ratio in amniotic fluid test system is a device intended to measure the lecithin/sphingomyelin ratioin amniotic fluid. Lecithin and sphingomyelin are phospholipids (fats or fat-like substances containing phosphorus). Measurements of the lecithin/sphingomyelin ratio in amniotic fluid are used in evaluating fetal maturity.

Official code: A.1460. Product type: Leucine aminopeptidase test. Official classification: Class 1. A leucine aminopeptidase test system is a device intended to measure the activity of the enzyme leucine amino-peptidase in serum, systemplasma, and urine. Leucine aminopeptidase measurements are used in the diagnosis and treatment of liver diseases such as viral hepatitis and obstructive jaundice.

Official code: A.1465. Product type: Lipase test system. Official classification: Class 1. A lipase test system is a device intended to measure the activity of the enzymes lipase in serum. Lipase measurements are used in diagnosis and treatment of diseases of the pancreas such as acute pancreatitis and obstruction of the pancreatic duct.

Official code: A.1470. Product type: Lipid (total) test system. Official classification: Class 1. A lipid (total) test system is a device intended to measure total lipids (fats or fat-like substances) in serum and plasma. Lipid (total) measurements are used in the diagnosis and treatment of various diseases involving lipid metabolism and atherosclerosis.

Official code: A.1475. Product type: Lipoprotein test system. Official classification: Class 1. A lipoprotein test system is a chemical analysis device intended to measure lipoprotein in serum and plasma. Lipoprotein measurements are used in the diagnosis and treatment of lipid disorders (such as diabetes mellitus),atherosclerosis, and various liver and renal diseases.

Official code: A.1485. Product type: Luteinizing hormone test system. Official classification: Class 1. A luteinizing hormone test system is a device intended to measure luteinizing hormone in serum and urine. Luteinizing hormone measurements are used in the diagnosis and treatment of gonadal dysfunction.

Official code: A.1490. Product type: Lysozyme (muramidase) test system. Official classification: Class 1. A lysozyme (muramidase) test system is a device intended to measure the activity of the bacteriolytic enzyme lysozyme (muramidase) in serum, plasma, leukocytes, and urine. Lysozyme measurements are used in the diagnosis and treatment of monocytic leukemia and kidney disease.

Official code: A.1495. Product type: Magnesium test system. Official classification: Class 1. A magnesium test system is a device intended to measure magnesium levels in serum and plasma. Magnesium measurements are used in the diagnosis and treatment of hypomagnesemia (abnormally low plasma levels of magnesium) and hypermagnesemia (abnormally high plasma levels of magnesium).

Official code: A.1500. Product type: Malic dehydrogenase test system. Official classification: Class 1. A malic dehydrogenase test system is a device that is intended to measure the activity of the enzyme malic dehydrogenase in serum and plasma. Malic dehydrogenase measurements are used in the diagnosis and treatment of muscle and liver diseases, myocardial infarctions, cancer, and blood disorders such as myelogenous (produced in the bone marrow) leukemia.

Official code: A.1505. Product type: Mucopolysaccharides (nonquantitative) test system. Official classification: Class 1. A mucopolysaccharides (nonquantitative) test system is a device intended to measure the levels of mucopolysaccharides in urine. Mucopolysaccharide measurements in urine are used in the diagnosis and treatment of various inheritable disorders that affect bone and connective tissues, such as Hurler's, Hunter's, Sanfilippo's, Scheie's Morquio's and Maroteaux-Lamy syndromes.

Official code: A.1509. Product type: Methylmalonic acid (nonquantitative) test system. Official classification: Class 2. A methylmalonic acid (nonquantitative) test system is a device intended to identify methylmalonic acid in urine. The identification of methylmalonic acid in urine is used in the diagnosis and treatment of methylmalonicaciduria, a heritable metabolic disorder which, if untreated, may cause mental retardation.

Official code: A.1510. Product type: Nitrite (nonquantitative) test system. Official classification: Class 1. A nitrite (nonquantitative) test system is a device intended to identify nitrite in urine. Nitrite identification is used in the diagnosis and treatment of urinary tract infection of bacterial origin.

Official code: A.1515. Product type: Nitrogen (amino-nitrogen) test system. Official classification: Class 1. A nitrogen (amino-nitrogen) test system is a device intended to measure amino acid nitrogen levels in serum, plasma, and urine. Nitrogen (amino-nitrogen) measurements are used in the diagnosis and treatment of certain forms of severe liver disease and renal disorders. A.15205'-Nucleotidase test system1A 5'-nucleotidase test system is a device intended to measure the activity of the enzyme 5'-nucleotidase in serum and plasma. Measurements of 5'-nucleotidase are used in the diagnosis and treatment of liver diseases and in the differentiations between liver and bone diseases in the presence of elevated serum alkaline phosphatase activity.

Official code: A.1530. Product type: Plasma oncometry test system. Official classification: Class 1. A plasma oncometry test system is a device intended to measure plasma oncotic pressure. Plasma oncotic pressure is that portion of the total fluid pressure contributed by proteins and other molecules toolarge to pass through a specified membrane. Measurements of plasma oncotic pressure are used in the diagnosis and treatment of dehydration and circulatory disorders related to low serum protein levels and increased capillary permeability, such as edema and shock.

Official code: A.1535. Product type: Ornithine carbamyl transferase test system. Official classification: Class 1. An ornithine carbamyl transferase test system is a device intended to measure the activity of the enzyme ornithine carbamyl transferase (OCT) in serum. Ornithine carbamyl transferase measurements are used in the diagnosis and treatment of liver diseases, such as infectious hepatitis, acute cholecystitis (inflammation of the gall bladder), cirrhosis, and liver metastases.

Official code: A.1540. Product type: Osmolality test system. Official classification: Class 1. An osmolality test system is a device intended to measure ionic and nonionic solute concentration in body fluids, such as serum and urine. Osmolality measurement is used as an adjunct to other tests in the evaluation of a variety of diseases, includingkidney diseases (e.g., chronic progressive renal failure), diabetes insipidus, other endocrine and metabolic disorders, and fluid imbalances.

Official code: A.1542. Product type: Oxalate test system. Official classification: Class 1. An oxalate test system is a device intended to measure the concentration of oxalate in urine. Measurements of oxalate are used to aid in the diagnosis or treatment of urinary stones or certain other metabolic disorders.

Official code: A.1545. Product type: Parathyroid hormone test system. Official classification: Class 2. A parathyroid hormone test system is a device intended to measure the levels of parathyroid hormone in serum and plasma. Measurements of parathyroid hormone levels are used in the differential diagnosis of hypercalcemia (abnormally high levels of calcium in the blood) and hypocalcemia (abnormally low levels of calcium in the blood) resulting from disorders of calcium metabolism.

Official code: A.1550. Product type: Urinary pH (nonquantitative) test system. Official classification: Class 1. A urinary pH (nonquantitative) test system is a device intended to estimate the pH of urine. Estimations of pH are used to evaluate the acidity or alkalinity of urine as it relates to numerous renal andmetabolic disorders and in the monitoring of patients with certain diets.

Official code: A.1555. Product type: Phenylalanine test system. Official classification: Class 2. A phenylalanine test system is a device intended to measure free phenylalanine (an amino acid) in serum, plasma, and urine. Measurements of phenylalanine are used in the diagnosis and treatment of congenital phenylketonuria which, if untreated, may cause mental retardation.

Official code: A.1560. Product type: Urinary phenylketones (nonquantitative) test system. Official classification: Class 1. A urinary phenylketones (nonquantitative) test system is a deviceintended to identify phenylketones (such as phenylpyruvic acid) in urine. The identification of urinary phenylketones is used in the diagnosis and treatment of congenital phenylketonuria which, if untreated, may cause mental retardation. A.15656-Phosphogluconate dehydrogenase test system 1A 6-phosphogluconate dehydrogenase test system is a device intended to measure the activity of the enzyme 6-phosphogluconate dehydrogenase (6 PGD) in serum and erythrocytes. Measurements of 6-phosphogluconate dehydrogenase are used in the diagnosis and treatment of certain liver diseases (such as hepatitis) and anemias.

Official code: A.1570. Product type: Phosphohexose isomerase test system. Official classification: Class 1. A phosphohexose isomerase test system is a device intended to measure the activity of the enzyme phosphohexose isomerase in serum. Measurements of phosphohexose isomerase are used in the diagnosis and treatment of muscle diseases such as muscular dystrophy, liver diseases such as hepatitis or cirrhosis, and metastatic carcinoma.

Official code: A.1575. Product type: Phospholipid test system. Official classification: Class 1. A phospholipid test system is a device intended to measure phospholipids in serum and plasma. Measurements of phospholipids are used in the diagnosis and treatment of disorders involving lipid (fat) metabolism.

Official code: A.1580. Product type: Phosphorus (inorganic) test system. Official classification: Class 1. A phosphorus (inorganic) test system is a device intended to measure inorganic phosphorus in serum, plasma, and urine. Measurements of phosphorus (inorganic) are used in the diagnosis and treatment of various disorders, including parathyroid gland and kidney diseases, and vitamin D imbalance.

Official code: A.1585. Product type: Human placental lactogen test system. Official classification: Class 2. A human placental lactogen test system is a device intended to measure the hormone human placental lactogen (HPL), (also known as human chorionic somatomammotrophin (HCS)), in maternal serum and maternal plasma. Measurements of human placental lactogen are used in the diagnosis and clinical management of high-risk pregnancies involving fetal distress associated with placental insufficiency. Measurements of HPL are also used in pregnancies complicated by hypertension, proteinuria, edema, post- maturity, placental insufficiency, or possible miscarriage.

Official code: A.1590. Product type: Porphobilinogen test system. Official classification: Class 1. A porphobilinogen test system is a device intended to measure porphobilinogen (one of the derivatives of hemoglobin which can make the urine a red color) in urine. Measurements obtained by this device are used in the diagnosis and treatment of porphyrias (primarily inherited diseases associated with disturbed porphyrine metabolism), leadpoisoning, and other diseases characterized by alterations in the heme pathway.

Official code: A.1595. Product type: Porphyrins test system. Official classification: Class 1. A porphyrins test system is a device intended to measure porphyrins (compounds formed during the biosynthesis of heme, a constituent of hemoglobin, and related compounds) in urine and feces. Measurements obtained by this device are used in the diagnosis and treatment of lead poisoning, porphyrias (primarily inherited diseases associated with disturbed porphyrin metabolism), and other diseases characterized by alterations in the heme pathway.

Official code: A.1600. Product type: Potassium test system. Official classification: Class 2. A potassium test system is a device intended to measure potassium in serum, plasma, and urine. Measurements obtained by this device are used to monitor electrolyte balance in the diagnosis and treatment of diseases conditions characterized by low or high blood potassium levels.

Official code: A.1605. Product type: Pregnanediol test system. Official classification: Class 1. A pregnanediol test system is a device intended to measure pregnanediol (a major urinary metabolic product of progesterone) in urine. Measurements obtained by this device are used in the diagnosis and treatment of disorders of the ovaries or placenta.

Official code: A.1610. Product type: Pregnanetriol test system. Official classification: Class 1. A pregnanetriol test system is a device intended to measure pregnanetriol (a precursorin the biosynthesis of the adrenal hormone cortisol) in urine. Measurements obtained by this device are used in the diagnosis and treatment of congenital adrenal hyperplasia (congenital enlargement of the adrenal gland).

Official code: A.1615. Product type: Pregnenolone test system. Official classification: Class 1. A pregnenolone test system is a device intended to measure pregnenolone (a precursor in the biosynthesis of the adrenal hormone cortisol and adrenal androgen) in serum and plasma. Measurements obtained by this device are used in the diagnosis and treatment of diseases of the adrenal cortex or the gonads.

Official code: A.1620. Product type: Progesterone test system. Official classification: Class 1. A progesterone test system is a device intended to measure progesterone (a female hormone) in serum and plasma. Measurements obtained by this device are used in the diagnosis and treatment of disorders of the ovaries or placenta.

Official code: A.1625. Product type: Prolactin (lactogen) test system. Official classification: Class 1. A prolactin (lactogen) test system is a device intended to measure the anterior pituitary polypeptide hormone prolactin in serum and plasma. Measurementsobtained by this device are used in the diagnosis and treatment of disorders of the anterior pituitary gland or of the hypothalamus portion of the brain.

Official code: A.1630. Product type: Protein (fractionation) test system. Official classification: Class 1. A protein (fractionation) test system is a device intended to measure protein fractions in blood, urine, cerebrospinal fluid, and other body fluids. Protein fractionations are used as an aid in recognizing abnormal proteins in body fluids and genetic variants of proteins produced in diseases with tissue destruction.

Official code: A.1635. Product type: Total protein test system. Official classification: Class 1. A total protein test system is a device intended to measure total protein(s) in serum or plasma. Measurements obtained by this device are used in the diagnosis and treatment of a variety of diseases involving the liver, kidney, or bone marrow as well as other metabolic or nutritional disorders.

Official code: A.1640. Product type: Protein-bound iodine test system. Official classification: Class 1. A protein-bound iodine test system is a device intended to measure protein-bound iodine in serum. Measurements of protein-bound iodine obtained by this device are used in the diagnosis and treatment of thyroid disorders.

Official code: A.1645. Product type: Urinary protein or albumin (nonquantitative) test system. Official classification: Class 1. A urinary protein or albumin (nonquantitative) test system is a device intended to identify proteins or albumin in urine. Identification of urinary protein or albumin (nonquantitative) is used in the diagnosis and treatment of disease conditions such as renal or heart diseases or thyroid disorders, which are characterized by proteinuria or albuminuria.

Official code: A.1650. Product type: Pyruvate kinase test system. Official classification: Class 1. A pyruvate kinase test system is a device intended to measure the activity of the enzyme pyruvate kinase in erythrocytes (redblood cells). Measurements obtained by this device are used in the diagnosis and treatment of various inherited anemias due to pyruvate kinase deficiency or of acute leukemias.

Official code: A.1655. Product type: Pyruvic acid test system. Official classification: Class 1. A pyruvic acid test system is a device intended to measure pyruvic acid (an intermediate compound in the metabolism of carbohydrate) in plasma. Measurements obtained by this device are used in the evaluation of electrolyte metabolism, and in the diagnosis and treatmentof acid-base andelectrolyte disturbances or anoxia (the reduction of oxygen in body tissues).

Official code: A.1660. Product type: Quality control material (assayed and unassayed). Official classification: Class 1,2. (a) Identification: A quality control material (assayed and unassayed) for clinical chemistry is a device intended for medical purposes for use in a test system to estimate test precision and to detect systematic analytical deviations that may arise from reagent or analytical instrument variation. A quality control material (assayed and unassayed) may be used for proficiency testing in interlaboratory surveys. This generic type of device includes controls (assayed and unassayed) for blood gases, electrolytes, enzymes, multianalytes (all kinds), single (specified) analytes, or urinalysis controls. (b) Classification: (1) Class 1: The device is not made from serum of human or animal origin, or is used for proficiency testingin interlaboratory surveys. (2) Class 2: The device is made from serum of human or animal origin, or is used for drug abuse detection.

Official code: A.1665. Product type: Sodium test system. Official classification: Class 2. A sodium test system is a device intended to measure sodium in serum, plasma, and urine. Measurements obtained by this device are used in the diagnosis and treatment of aldosteronism (excessive secretion of the hormone aldosterone), diabetes insipidus (chronic excretion of large amounts of dilute urine, accompanied by extreme thirst), adrenal hypertension, Addison's disease (caused by destruction of the adrenal glands), dehydration, inappropriate antidiuretic hormone secretion, or other diseases involving electrolyte imbalance.

Official code: A.1670. Product type: Sorbitol dehydrogenase test system. Official classification: Class 1. A sorbitol dehydrogenasetest system is a device intended to measure the activity of the enzyme sorbitol dehydrogenase in serum. Measurements obtained by this device are used in the diagnosis and treatment of liver disorders such as cirrhosis or acute hepatitis.

Official code: A.1675. Product type: Blood specimen collection device. Official classification: Class 2. A blood specimen collection device is a device intended for medical purposes to collect and to handle blood specimens and to separate serum from nonserum (cellular) components prior to further testing. This generic type device mayinclude blood collection tubes, vials, systems, serum separators, blood collection trays, or vacuum sample tubes, blood sampling paper and other similar devices.

Official code: A.1678. Product type: Tacrolimus test system. Official classification: Class 2. A tacrolimus test system is a device intended to quantitatively determine tacrolimus concentrations as an aid in the management of transplant patients receiving therapy with this drug. This generic type of device includes immunoassays and chromatographic assays for tacrolimus.

Official code: A.1680. Product type: Testosterone test system. Official classification: Class 1. A testosterone test system is a device intended to measure testosterone (a male sex hormone) in serum, plasma, and urine. Measurement of testosterone are used in the diagnosis and treatment of disorders involving the male sex hormones (androgens), including primary and secondary hypogonadism, delayed or precocious puberty, impotence in male’s and, in female’s hirsutism (excessive hair) and virilization (masculinization) due to tumors, polycystic ovaries, and adrenogenital syndromes.

Official code: A.1685. Product type: Thyroxine-binding globulin test system. Official classification: Class 2. A thyroxine-binding globulin test system is a device intended to measure thyroxine (thyroid)-binding globulin (TBG), a plasma protein which binds thyroxine, in serum and plasma. Measurements obtained by this device are used in the diagnosis and treatment of thyroid diseases.

Official code: A.1690. Product type: Thyroid stimulating hormone test system. Official classification: Class 2. A thyroid stimulating hormone test system is a device intended to measure thyroid stimulating hormone, also known as thyrotrophin and thyrotrophic hormone, in serumand plasma. Measurements of thyroid stimulating hormone produced by the anterior pituitary are used in the diagnosis of thyroid or pituitary disorders.

Official code: A.1695. Product type: Free thyroxine test system. Official classification: Class 2. A free thyroxine test system is a device intended to measure free (not protein bound) thyroxine (thyroid hormone) in serum or plasma. Levels of free thyroxine in plasma are thought to reflect the amount of thyroxine hormone available to the cells andmay therefore determine the clinical metabolic status of thyroxine. Measurements obtained by this device are used in the diagnosis and treatment of thyroid diseases.

Official code: A.1700. Product type: Total thyroxine test system. Official classification: Class 2. A total thyroxine test system is a device intended to measure total (free and protein bound) thyroxine (thyroid hormone) inserum and plasma. Measurements obtained by this device are used in the diagnosis and treatment of thyroid diseases.

Official code: A.1705. Product type: Triglyceride test system. Official classification: Class 1. A triglyceride test system is a device intended to measure triglyceride (neutral fat) in serum and plasma. Measurements obtained by this device are used in the diagnosis and treatment of patients with diabetes mellitus, nephrosis, liver obstruction, other diseases involving lipid metabolism, or various endocrine disorders.

Official code: A.1710. Product type: Total triiodothyronine test system. Official classification: Class 1. A total triiodothyronine test system is a device intended to measure the hormone triiodothyronine in serum and plasma. Measurements obtained by this device are used in the diagnosis and treatment of thyroid diseases such as hyperthyroidism.

Official code: A.1715. Product type: Triiodothyronine uptake test system. Official classification: Class 1. A triiodothyronine uptake test system is a device intended to measure the total amount of binding sites available for bindingthyroid hormone on the thyroxine-binding proteins, thyroid-binding globulin, thyroxine-binding prealbumin, and albumin of serum and plasma. The device provides an indirect measurement of thyrkoxine levels in serum and plasma. Measurements of triiodothyronine uptake are used in the diagnosis and treatment of thyroid disorders.

Official code: A.1720. Product type: Triose phosphate isomerase test system. Official classification: Class 1. A triose phosphate isomerase test system is a device intended to measure the activity of the enzyme triose phosphate isomerase in erythrocytes (red blood cells). Triose phosphate isomerase is an enzyme important in glycolysis (the energy-yielding conversion of glucose to lactic acid in various tissues). Measurements obtained by this device are used in the diagnosis and treatment of congenital triose phosphate isomerase enzyme deficiency, which causes a type of hemolytic anemia.

Official code: A.1725. Product type: Trypsin test system. Official classification: Class 1. A trypsin test system is a device intended to measure the activity of trypsin (a pancreatic enzyme important in digestion forthe breakdown of proteins) in blood and other body fluids and in feces. Measurements obtained by this device are used in the diagnosis and treatment of pancreatic disease.

Official code: A.1730. Product type: Free tyrosine test system. Official classification: Class 1. A free tyrosine test system is a device intended to measure free tyrosine (an amino acid) in serum and urine. Measurements obtained by this deviceare used in the diagnosis and treatment of diseases such as congenital tyrosinemia (a disease that can cause liver/kidney disorders) and as an adjunct to the measurement of phenylalanine in detecting congenital phenylketonuria (a disease that can cause brain damage).

Official code: A.1770. Product type: Urea nitrogen test system. Official classification: Class 2. A urea nitrogen test system is a device intended to measure urea nitrogen (an end-product of nitrogen metabolism) in whole blood, serum, plasma, and urine. Measurements obtained by this device are used in the diagnosis and treatment of certain renal and metabolic diseases.

Official code: A.1775. Product type: Uric acid test system. Official classification: Class 1. A uric acid test system is a device intended to measure uric acid in serum, plasma, and urine. Measurements obtained by thisdevice are used in the diagnosisand treatment of numerous renal and metabolic disorders, including renal failure, gout, leukemia, psoriasis, starvation or other wasting conditions, and of patients receiving cytotoxic drugs.

Official code: A.1780. Product type: Urinary calculi (stones) test system. Official classification: Class 1. A urinary calculi (stones) test system is a device intended for the analysis of urinary calculi. Analysis of urinary calculi is used in the diagnosis and treatment of calculi of the urinary tract.

Official code: A.1785. Product type: Urinary urobilinogen (nonquantitative) test system. Official classification: Class 1. A urinary urobilinogen (nonquantitative) test system is a device intended to detect and estimate urobilinogen (a bile pigment degradation product of red cell hemoglobin) in urine. Estimations obtained by this device are used in the diagnosis and treatment of liver diseases and hemolytic (red cells) disorders.

Official code: A.1790. Product type: Uroporphyrin test system. Official classification: Class 1. A uroporphyrin test system is a device intended to measure uroporphyrin in urine. Measurements obtained by this device are used in the diagnosis and treatment of porphyrias (primarily inherited diseases associated with disturbed porphyrin metabolism), lead poisoning, and other diseases characterized by alterations in the heme pathway.

Official code: A.1795. Product type: Vanilmandelic acid test system. Official classification: Class 1. A vanilmandelic acid test system is a device intended to measure vanilmandelic acid in urine. Measurements of vanilmandelic acid obtained by this device are used in the diagnosis and treatment of neuroblastoma, pheochromocytoma, and certain hypertensive conditions.

Official code: A.1805. Product type: Vitamin A test system. Official classification: Class 1. A vitamin A testsystem is a device intended to measure vitamin A in serum or plasma. Measurements obtained by this device are used in the diagnosis and treatment of vitamin A deficiency conditions, including night blindness, or skin, eye, or intestinal disorders.

Official code: A.1810. Product type: Vitamin B12 test system. Official classification: Class 2. A vitamin B12 test system is a device intended to measure vitamin B12in serum, plasma, and urine. Measurements obtained by this device are used in the diagnosis and treatment of anemias of gastrointestinal malabsorption.

Official code: A.1815. Product type: Vitamin E test system. Official classification: Class 1. A vitamin E test system is a device intended to measure vitamin E (tocopherol) in serum. Measurements obtained by this device are used in the diagnosis and treatment of infants with vitamin E deficiency syndrome.

Official code: A.1820. Product type: Xylose test system. Official classification: Class 1. A xylose test system is a device intended to measure xylose (a sugar) in serum, plasma, and urine. Measurements obtained by this device are used in the diagnosis and treatment of gastrointestinal malabsorption syndrome (a group of disorders in which there is subnormal absorption of dietary constituents and thus excessive loss from the body of the nonabsorbed substances).

Official code: A.1825. Product type: Vitamin D test system. Official classification: Class 2. A vitamin D test system is a device intended for use in clinical laboratories for the quantitative determination of 25-hydroxyvitamin D (25-OH-D) and other hydroxylated metabolites of vitamin D in serum or plasma to be used in the assessment of vitamin D sufficiency.

Official code: A.1840. Product type: Total 25-hydroxyvitamin D mass spectrometry test system. Official classification: Class 2. A total 25-hydroxyvitamin D mass spectrometry test system is a device intended for use in clinical laboratories for the quantitative determination of total 25-hydroxyvitamin D (25-OH-D) in serum or plasma to be used in the assessment of vitamin D sufficiency.

Official code: A.2140. Product type: Centrifugal chemistry analyzer for clinical use. Official classification: Class 1. A centrifugal chemistry analyzer for clinical use is an automatic device intended to centrifugally mix a sample and a reagentand spectrophotometrically measure concentrations of the sample constituents. This device is intended for use in conjunction with certain materials to measure a variety of analytes.

Official code: A.2150. Product type: Continuous flow sequential multiple chemistry analyzer for clinical use. Official classification: Class 1. A continuous flow sequential multiple chemistry analyzer for clinical use isa modular analytical instrument intended to simultaneously perform multiple chemical procedures using the principles of automated continuous flow systems. This device is intended for use in conjunction with certain materials to measure a variety of analytes.

Official code: A.2160. Product type: Discrete photometric chemistry analyzer for clinical use. Official classification: Class 1. A discrete photometric chemistry analyzer for clinical use is a device intended to duplicate manual analytical procedures by performing automatically various steps such as pipetting, preparing filtrates, heating, and measuring color intensity. This device is intended for use in conjunction with certain materials to measure a variety of analytes. Different models of the device incorporate various instrumentation such as micro analysis apparatus, double beam, single, or dual channel photometers, and bichromatic 2- wavelength photometers. Some models of the device may include reagent-containing components that may also serve as reaction units.

Official code: A.2170. Product type: Micro chemistry analyzer for clinical use. Official classification: Class 1. A micro chemistry analyzer for clinical use is a device intended to duplicate manual analytical procedures by performing automatically various steps such as pipetting, preparing filtrates, heating, and measuring color intensity. The distinguishing characteristic of the device is that it requires only micro volume samples obtainable from pediatric patients. This device is intended for use in conjunction with certain materials to measure a variety of analytes.This item does not include instrumentation for clinical multiplex test systems (A.2570) to measure and analyze multiple signals generated from a single test.

Official code: A.2250. Product type: Gas liquid chromatography system for clinical use. Official classification: Class 1. A gas liquid chromatography system for clinical use is a device intended to separateone or more drugs or compounds from a mixture. Each of the constituents in a vaporized mixture of compounds is separated according to its vapor pressure. The device may include accessories such as columns, gases, column supports, and liquid coating.

Official code: A.2260. Product type: High pressure liquid chromatography system for clinical use. Official classification: Class 1. A high pressure liquid chromatography system for clinical use is a device intended to separate one or more drugs or compounds from a solution by processing the mixture of compounds (solutes) through a column packed with materials of uniform size (stationary phase) under the influence of a high pressure liquid (mobile phase). Separation of the solutes occurs either by absorption, sieving, partition, or selective affinity.

Official code: A.2265. Product type: High throughput genomic sequence analyzer for clinical use. Official classification: Class 2. A high throughput genomic sequence analyzer for clinical use is an analytical instrument system intended to generate, measure and sort signals in order to analyze nucleic acid sequences in a clinical sample. The device may include a signal reader unit; reagent handling, dedicated instrument control, and other hardware components; raw data storage mechanisms; data acquisition software; and software to process detected signals.

Official code: A.2270. Product type: Thin-layer chromatography system for clinical use. Official classification: Class 1. A thin-layer chromatography (TLC) system for clinical use is a device intended to separate one or more drugs or compounds from a mixture. The mixture of compounds is absorbed onto a stationary phase or thin layer of inert material (e.g., cellulose, alumina, etc.) and eluted off by a moving solvent (moving phase) until equilibrium occurs between the two phases.

Official code: A.2300. Product type: Colorimeter, photometer, or spectrophotometer for clinical use. Official classification: Class 1. A colorimeter, a photometer, or a spectrophotometerfor clinical use is an instrument intended to measure radiant energy emitted, transmitted, absorbed, or reflected under controlled conditions. The device may include a monochromator to produce light of a specific wavelength.

Official code: A.2320. Product type: Beta or gamma counter for clinical use. Official classification: Class 1. A beta or gamma counter for clinical use is a device intended to detect and count beta or gamma radiation emitted by clinical samples. Clinical samples are prepared by addition of a radioactive reagent to the sample. These measurements are useful in the diagnosis and treatment of various disorders.

Official code: A.2400. Product type: Densitometer/scanner (integrating, reflectance, TLC, or. Official classification: Class 1. A densitometer/scanner (integrating, reflectance, thin-layer chromatography, or radiochromatogram) for clinical use is device intended to measure the concentration of a substance on the surface of a film or other support media by either a photocell measurement of the light transmission through a given area of the medium or, in the case of the radiochromatogram scanner, by radiochromatogram) for clinical use measurement of the distribution of a specific radio-active element on a radiochromatogram.

Official code: A.2485. Product type: Electrophoresis apparatus for clinical use. Official classification: Class 1. An electrophoresis apparatus for clinical use is a device intended to separate molecules or particles, including plasma proteins, lipoproteins, enzymes, and hemoglobulin on the basis of their net charge in specified buffered media. This device is used in conjunction with certain materials to measure a variety of analytes as an aid in the diagnosis and treatment of certain disorders.

Official code: A.2500. Product type: Enzyme analyzer for clinical use. Official classification: Class 1. An enzyme analyzer for clinical use is a device intended to measure enzymes in plasma or serum by nonkinetic or kinetic measurement of enzyme-catalyzed reactions. Thisdevice is used in conjunction with certain materials to measure a variety of enzymes as an aid in the diagnosis and treatment of certain enzyme-related disorders.

Official code: A.2540. Product type: Flame emission photometer for clinical use. Official classification: Class 1. A flame emission photometer for clinicaluse is a device intended to measure the concentration of sodium, potassium, lithium, and other metal ions in body fluids. Abnormal variations in the concentration of these substances in the body are indicative of certain disorders (e.g., electrolyte imbalance and heavy metal intoxication), therefore, it isuseful in diagnosis and treatment of those disorders.

Official code: A.2560. Product type: Fluorometer for clinical use. Official classification: Class 1. A fluorometer for clinical use is a device intended to measure by fluorescence certain analytes. Fluorescenceis the property of certain substances of radiating, when illuminated, a light of a different wavelength. This device is used in conjunction withcertain materials to measure a variety of analytes.

Official code: A.2570. Product type: Instrumentation for clinical multiplex test systems. Official classification: Class 2. Instrumentation for clinical multiplex test systems is a device intended to measure and sort multiple signals generated by anassay from a clinical sample. This instrumentation is used with a specific assay to measure multiple similar analytes that establish a single indicator to aid in diagnosis. Such instrumentation may be compatible with more than one specific assay. The device includes a signal reader unit, and may also integrate reagent handling, hybridization, washing, dedicated instrument control, and other hardware components, as well as raw data storage mechanisms, data acquisition software, and software to process detected signals.

Official code: A.2700. Product type: Nephelometer for clinical use. Official classification: Class 1. A nephelometer for clinical use is a device intended to estimate the concentration of particles in a suspension by measuring their light scattering properties (the deflection of light rays by opaque particles in their path). The device is used in conjunction with certain materials to measure the concentration of a variety of analytes.

Official code: A.2720. Product type: Plasma oncometer for clinical use. Official classification: Class 1. A plasma oncometer for clinical use is a device intended to measure plasma oncotic pressure, which is that portion of the total plasma osmotic pressure contributed by protein and other molecules too largeto pass through a specified semipermeable membrane. Because variations in plasma oncotic pressure are indications of certain disorders, measurements of the variationsare useful in the diagnosis and treatment of these disorders.

Official code: A.2730. Product type: Osmometer for clinical use. Official classification: Class 1. An osmometer for clinical use is a device intended to measure the osmotic pressure of body fluids. Osmotic pressure is the pressure required to prevent the passage of a solution with a lesser solute concentration into a solution with greater solute concentration when the two solutions are separated by a semipermeable membrane. The concentration of a solution affects its osmotic pressure, freezing point, and other physiochemical properties. Osmometers determine osmotic pressure by methods such as the measurement of the freezing point. Measurements obtained by this device are used in the diagnosis and treatment of body fluid disorders.

Official code: A.2800. Product type: Refractometer for clinical use. Official classification: Class 1. A refractometer for clinical use is a device intended to determine the amount of solute in a solution by measuring the index of refraction (the ratio of the velocity of light in a vacuum to the velocity of light in the solution). The index of refractionis used to measure the concentration of certain analytes (solutes), such a plasma total proteins and urinary total solids. Measurements obtained by this device are used in the diagnosis and treatment of certain conditions.

Official code: A.2850. Product type: Atomic absorption spectrophotometer for clinical use. Official classification: Class 1. An atomic absorption spectrophotometer for clinical use is a device intended to identify and measure elements and metals (e.g., lead and mercury) in human specimens. The metal elements are identified according to the wavelength and intensity of the light that is absorbed when the specimen is convertedto the atomic vapor phase. Measurements obtained by this device are used in the diagnosis and treatment of certain conditions.

Official code: A.2860. Product type: Mass spectrometer for clinical use. Official classification: Class 1. A mass spectrometer for clinical use is a device intended to identify inorganic or organic compounds (e.g., lead, mercury, and drugs) in human specimens by ionizing the compound under investigation and separating the resulting ions by means of an electrical and magnetic field according to their mass.

Official code: A.2900. Product type: Automated urinalysis system. Official classification: Class 1. An automated urinalysis system is a device intended to measure certain of the physical properties and chemical constituents of urine by procedures that duplicate manual urinalysis systems. This device is used in conjunction with certain materials to measure a variety of urinary analytes.

Official code: A.2920. Product type: Plasma viscometer for clinical use. Official classification: Class 1. A plasma viscometer for clinical use is a device intended to measure the viscosity of plasma by determining the time period required for the plasma to flow a measured distance through a calibrated glass tube. Measurements obtained by this device are used to monitor changes in the amount of solids present in plasma in various disorders.

Official code: A.3030. Product type: Acetaminophen tests system. Official classification: Class 2. An acetaminophen test system is a device intended to measure acetaminophen, an analgesic and fever reducing drug, in serum. Measurements obtained by this device are used in the diagnosis and treatment of acetaminophen overdose.

Official code: A.3035. Product type: Amikacin test system. Official classification: Class 2. An amikacin test system is a device intended to measureamikacin, an aminoglycoside antibiotic drug, in serum and plasma. Measurements obtained by this device are used in the diagnosis and treatment of amikacin overdose and in monitoring levels of amikacin to ensure appropriate therapy.

Official code: A.3040. Product type: Alcohol test system. Official classification: Class 2. An alcohol test system is a device intended to measure alcohol (e.g., ethanol, methanol, isopropanol, etc.) in human body fluids (e.g., serum, whole blood, and urine). Measurements obtained by this device are used in the diagnosis and treatment of alcohol intoxication and poisoning.

Official code: A.3050. Product type: Breath-alcohol test system. Official classification: Class 1. A breath-alcohol test system is a device intended to measure alcohol in the human breath.Measurements obtained by this device are used in the diagnosis of alcohol intoxication.

Official code: A.3080. Product type: Breath nitric oxide test system. Official classification: Class 2. A breath nitric oxide test system is a device intended to measure fractional nitric oxide in human breath. Measurement of changes in fractional nitric oxide concentration in expired breath aids in evaluating an asthma patient's response to anti-inflammatory therapy, as an adjunct to established clinical and laboratory assessments of asthma. A breath nitric oxide test system combines chemiluminescence detection of nitric oxide with a pneumotachograph, display, and dedicated software.

Official code: A.3100. Product type: Amphetamine test system. Official classification: Class 2. An amphetamine test system is a device intended to measure amphetamine, a central nervous system stimulating drug, in plasma and urine. Measurements obtained by this device are used in the diagnosis and treatment of amphetamine use or overdose and in monitoring levels of amphetamine to ensure appropriate therapy.

Official code: A.3110. Product type: Antimony test system. Official classification: Class 1. An antimony test system is a device intended to measure antimony, a heavy metal, in urine, blood, vomitus, and stomach contents. Measurements obtained by this device are used in the diagnosis and treatment of antimony poisoning.

Official code: A.3120. Product type: Arsenic test system. Official classification: Class 1. An arsenic test system is a device intended to measure arsenic, a poisonous heavy metal, in urine, vomitus, stomach contents, nails, hair, and blood. Measurements obtained by this device are used in the diagnosis and treatment of arsenic poisoning.

Official code: A.3150. Product type: Barbiturate test system. Official classification: Class 2. A barbiturate test system is a device intended to measure barbiturates, a class of hypnoticand sedative drugs, in serum, urine, and gastric contents. Measurements obtained by this device are used in the diagnosis and treatment of barbiturate use or overdoseand in monitoring levels of barbiturate to ensure appropriate therapy.

Official code: A.3170. Product type: Benzodiazepine test system. Official classification: Class 2. A benzodiazepine test system is a device intended to measure any of the benzodiazepine compounds, sedative and hypnotic drugs, in blood, plasma, and urine. The benzodiazepine compounds include chlordiazepoxide, diazepam, oxazepam, chlorzepate, flurazepam, and nitrazepam. Measurements obtained by this device are used in the diagnosis and treatment of benzodiazepine use or overdose and in monitoring levels of benzodiazepines to ensure appropriate therapy.

Official code: A.3200. Product type: Clinical toxicology calibrator. Official classification: Class 2. A clinical toxicology calibrator is a device intended for medical purposes for use in a test system to establish points of reference that are used in the determination of values in the measurement of substances in human specimens. A clinical toxicology calibrator can be a mixture of drugs or a specific material for a particular drug (e.g., ethanol, lidocaine, etc.).

Official code: A.3220. Product type: Carbon monoxide test system. Official classification: Class 1. A carbon monoxide test system is a device intended to measure carbon monoxide or carboxyhemoglobin(carbon monoxide bound to the hemoglobin in the blood) in blood. Measurements obtained by this device are used in the diagnosis and treatment of or confirmation of carbon monoxide poisoning.

Official code: A.3240. Product type: Cholinesterase test system. Official classification: Class 1. A cholinesterase test system is a device intended to measure cholinesterase (an enzyme that catalyzes the hydrolysis of acetylcholine to choline) in human specimens. There are two principal types of cholinesterase in human tissues. True cholinesterase is present at nerve endings andin erythrocytes (red blood cells) but is not present in plasma. Pseudo cholinesterase is present in plasma and liver but is not present in erythrocytes. Measurements obtained by this device are used in the diagnosis and treatment of cholinesterase inhibition disorders (e.g., insecticide poisoning, and succinylcholine poisoning).

Official code: A.3250. Product type: Cocaine and cocaine metabolite test system. Official classification: Class 2. A cocaine and cocaine metabolite test system is a device intended to measure cocaine and a cocaine metabolite (benzoylecgonine) in serum, plasma, and urine. Measurements obtained by this device are used in the diagnosis and treatment of cocaine use or overdose.

Official code: A.3270. Product type: Codeine test system. Official classification: Class 2. A codeine test system is a device intended to measure codeine (a narcotic pain-relieving drug) in serum and urine. Measurements obtained by this device are used in the diagnosis and treatment of codeine use or overdose and in monitoring levels of codeine to ensure appropriate therapy.

Official code: A.3300. Product type: Digitoxin test system. Official classification: Class 2. A digitoxin test system is adevice intended to measure digitoxin, a cardiovascular drug, in serum and plasma. Measurements obtained by this device are used in the diagnosis and treatment of digitoxin overdose and in monitoring levels of digitoxin to ensure appropriate therapy.

Official code: A.3320. Product type: Digoxin test system. Official classification: Class 2. A digoxin test system is a device intended to measure digoxin, a cardiovascular drug, in serum and plasma. Measurements obtained by this device are used in the diagnosis and treatment of digoxin overdose and in monitoring levels ofdigoxin to ensure appropriate therapy.

Official code: A.3350. Product type: Diphenylhydantoin test system. Official classification: Class 2. A diphenylhydantoin test system is a device intended to measure diphenylhydantoin, an antiepileptic drug, in human specimens. Measurements obtained by this device are used in the diagnosis and treatment of diphenylhydantoin overdose and in monitoring levels of diphenylhydantoin to ensure appropriate therapy.

Official code: A.3360. Product type: Drug metabolizing enzyme genotyping system. Official classification: Class 2. A drug metabolizing enzyme genotyping system is a device intended foruse in testing deoxyribonucleic acid (DNA) extracted from clinical samples to identify the presence or absence of human genotypic markers encoding a drug metabolizing enzyme. This device is used as an aid in determining treatment choice and individualizing treatment dose for therapeutics that are metabolized primarily by the specific enzyme about which the system provides genotypic information.

Official code: A.3380. Product type: Ethosuximide test system. Official classification: Class 2. An ethosuximide test system is a device intended to measure ethosuximide concentrations, an antiepileptic drug, in human specimens. Measurements obtained by this device are used in the diagnosis and treatment of ethosuximide overdose and in monitoring levels of ethosuximide to ensure appropriate therapy.

Official code: A.3450. Product type: Gentamicin test system. Official classification: Class 2. A gentamicin test system is a device intended to measure gentamicin, an antibiotic drug, in human specimens. Measurements obtained by this device are used in the diagnosis and treatment of gentamicin overdose and in monitoring levels of gentamicinto ensure appropriate therapy.

Official code: A.3520. Product type: Kanamycin test system. Official classification: Class 2. A kanamycin test system is a device intended to measure kanamycin, an antibiotic drug, in plasma and serum. Measurements obtained by this device are used in the diagnosis and treatment of kanamycin overdose and in monitoring levels of kanamycin to ensure appropriate therapy.

Official code: A.3550. Product type: Lead test system. Official classification: Class 2. A lead test system is a device intended to measure lead, a heavy metal, in blood and urine. Measurements obtained by this device are used in the diagnosis and treatment of lead poisoning.

Official code: A.3555. Product type: Lidocaine test system. Official classification: Class 2. A lidocaine test system is a device intended to measure lidocaine, an antiarrhythmic and anticonvulsant drug, in serum and plasma. Measurements obtained by this device are used in the diagnosis and treatment of lidocaine overdose or in monitoring levels of lidocaine to ensure appropriate therapy.

Official code: A.3560. Product type: Lithium test system. Official classification: Class 2. A lithium test system is a device intended to measure the concentration of lithium (from the drug lithium carbonate) in serum or plasma. Measurements of lithium are used to assure that the proper drug dosage is administered in the treatment of patients with mental disturbances, such as manic-depressive illness.

Official code: A.3580. Product type: Lysergic acid diethylamide (LSD) test system. Official classification: Class 2. Alysergic acid diethylamide (LSD) test system is a device intended to measure lysergic acid diethylamide concentrations, a hallucinogenic drug, in serum, urine, and gastric contents. Measurements obtained by this device are used in the diagnosis and treatment of LSD use or overdose.

Official code: A.3590. Product type: Meprobamate test system. Official classification: Class 2. A meprobamate test system is a device intended to measure meprobamate in human specimens. Measurements obtained by this device are used to detect the presence of meprobamate to diagnose the use or overdose of meprobamate or structurally-related drug compounds (e.g., prodrugs).

Official code: A.3600. Product type: Mercury test system. Official classification: Class 1. A mercury test system is a device intended to measure mercury, a heavy metal, in human specimens. Measurements obtained by this device are used in the diagnosis and treatment of mercury poisoning.

Official code: A.3610. Product type: Methamphetamine test system. Official classification: Class 2. A methamphetamine test system is a device intended to measure methamphetamine, a central nervous system stimulating drug, in serum, plasma, and urine. Measurementsobtained by this device are used in the diagnosis and treatment of methamphetamine use or overdose.

Official code: A.3620. Product type: Methadone test system. Official classification: Class 2. A methadone test system is a device intended to measure methadone, an addictive narcotic pain-relieving drug, in serum andurine. Measurements obtained by this device are used in the diagnosis and treatment of methadone use or overdose and to determine compliance with regulations in methadone maintenance treatment.

Official code: A.3630. Product type: Methaqualone test system. Official classification: Class 2. A methaqualone test systemis a device intended to measure methaqualone, a hypnotic and sedative drug, in urine. Measurements obtained by this device are used in the diagnosis and treatment of methaqualone use or overdose.

Official code: A.3640. Product type: Morphine test system. Official classification: Class 2. A morphine test system is a device intended to measure morphine, an addictive narcotic pain-relieving drug, and its analogs in serum, urine, and gastric contents. Measurements obtained by this device are used in the diagnosis and treatment of morphineuse or overdose and in monitoring levels of morphine and its analogs to ensure appropriate therapy.

Official code: A.3645. Product type: Neuroleptic drugs radioreceptor assay test system. Official classification: Class 2. A neuroleptic drugs radioceptor assay test system is a device intended to measure in serum or plasma the dopamine receptor blocking activity of neuroleptic drugs and their active metabolites. A neuroleptic drug has anti-psychotic action affecting principally psychomotor activity, is generally without hypnotic effects, and is a tranquilizer. Measurements obtained by this device areused to aid in determining whether a patient is taking the prescribed dosage level of such drugs.

Official code: A.3650. Product type: Opiate test system. Official classification: Class 2. An opiate test system is a device intended to measure any of the addictive narcotic pain-relieving opiate drugs in blood, serum, urine, gastric contents, and saliva. An opiate is any natural or synthetic drug that has morphine-like pharmacological actions. The opiates include drugs such as morphine, morphine glucoronide, heroin, codeine, nalorphine, and meperedine. Measurements obtained by this device are used in the diagnosis and treatment of opiate use or overdose and in monitoring the levels of opiate administration to ensure appropriate therapy.

Official code: A.3652. Product type: Organophosphate test system. Official classification: Class 2. An organophosphate test system is a device intended to measure organophosphate metabolites quantitatively in human urine from individuals who have signs and symptoms consistent with cholinesterase poisoning. The data obtained by this device is intended to aid in the confirmation and investigation of organophosphate exposure.

Official code: A.3660. Product type: Phenobarbital test system. Official classification: Class 2. A phenobarbitol test system is a device intended to measure phenobarbital, an antiepileptic and sedative-hypnotic drug, in human specimens. Measurements obtained by this device are used in the diagnosis and treatment of phenobarbital use or overdose and in monitoring levels of phenobarbital to ensure appropriate therapy.

Official code: A.3670. Product type: Phenothiazine test system. Official classification: Class 2. A phenothiazine test system is a device intended to measure any of the drugs of the phenothiazine class in human specimens. Measurements obtained by this device are used in the diagnosis and treatment of phenothiazine use or overdose.

Official code: A.3680. Product type: Primidone test system. Official classification: Class 2. A primidone test system is a device intended to measure primidone, an antiepileptic drug, in human specimens. Measurements obtained by this device are used in the diagnosis and treatment of primidone overdose and in monitoring levels of primidone to ensure appropriate therapy.

Official code: A.3700. Product type: Propoxyphene test system. Official classification: Class 2. A propoxyphene test system is a device intended to measure propoxyphene, a pain-relieving drug, in serum, plasma, and urine. Measurements obtained by this device are used in the diagnosis and treatment of propoxyphene use or overdose or in monitoring levels of propoxyphene to ensure appropriate therapy.

Official code: A.3750. Product type: Quinine test system. Official classification: Class 1. A quinine test system is a device intended to measure quinine, a fever-reducing and pain-relieving drug intended in the treatment of malaria, in serum and urine. Measurements obtained by this device areused in the diagnosis and treatment of quinine overdose and malaria.

Official code: A.3830. Product type: Salicylate test system. Official classification: Class 2. A salicylate test system is a device intended to measure salicylates, a class of analgesic, antipyretic and anti-inflammatory drugs that includes aspirin, in human specimens. Measurements obtained by this device are used in diagnosis and treatment of salicylate overdose and in monitoring salicylate levels to ensure appropriate therapy.

Official code: A.3840. Product type: Sirolimus test system. Official classification: Class 2. A sirolimus test system is a device intended to quantitatively determine sirolimus concentrations in whole blood. Measurements are used as an aid in management of transplant patients receiving therapy with sirolimus.

Official code: A.3850. Product type: Sulfonamide test system. Official classification: Class 1. A sulfonamide test system is a device intended to measure sulfonamides, any of the antibacterial drugs derived from sulfanilamide, in human specimens. Measurements obtained by this device are used in the diagnosis and treatment of sulfonamide overdose and in monitoring sulfonamide levels to ensure appropriate therapy.

Official code: A.3870. Product type: Cannabinoid test system. Official classification: Class 2. A cannabinoid test system is a device intended to measure any of the cannabinoids, hallucinogenic compounds endogenous to marihuana, in serum, plasma, saliva, and urine. Cannabinoid compounds include delta-9-tetrahydrocannabinol, cannabidiol, cannabinol, and cannabichromene. Measurements obtained by this device are used in the diagnosis and treatment of cannabinoid use or abuse and in monitoring levels of cannabinoids during clinical investigational use.

Official code: A.3880. Product type: Theophylline test system. Official classification: Class 2. A theophylline test system is a device intended to measure theophylline (a drug used for stimulation of the muscles in the cardiovascular, respiratory, and central nervous systems) in serum and plasma. Measurements obtained by this device are used in the diagnosis and treatment of theophylline overdose or in monitoring levels of theophylline to ensure appropriate therapy.

Official code: A.3900. Product type: Tobramycin test system. Official classification: Class 2. A tobramycin test system is a device intended to measure tobramycin, an aminoglycoside antibiotic drug, in plasma and serum. Measurements obtained by this device are used in the diagnosis and treatment of tobramycin overdose and in monitoring levelsof tobramycin to ensure appropriate therapy.

Official code: A.3910. Product type: Tricyclic antidepressant drugs test system. Official classification: Class 2. A tricyclic antidepressant drugs test system is a device intended to measure any of the tricyclic antidepressant drugs in serum. The tricyclic antidepressant drugs include imipramine, desipramine, amitriptyline, nortriptyline, protriptyline, and doxepin. Measurements obtained by this device are used in the diagnosis and treatment of chronic depression to ensure appropriate therapy.

Official code: A.3950. Product type: Vancomycin test system. Official classification: Class 2. A vancomycin test system is a device intended to measure vancomycin,an antibiotic drug, in serum. Measurements obtained by this device are used in the diagnosis and treatment of vancomycin overdose and in monitoring the level of vancomycin to ensure appropriate therapy.

Official code: A.9999. Product type: Others (Clinical Chemistry and Clinical Toxicology Devices) 1,. Official classification: Class 2,3. The products excluded from the above-classification are adopted in this classification and specified by the central competent health authority.

Official code: B.0001. Product type: Human leukocyte antigen typing system. Official classification: Class 2. Human leukocyte antigen typing system is a device for human leukocyte antigen identification and typing.

Official code: B.0002. Product type: Blood component extractor. Official classification: Class 1,2. Blood component extractor is a device to separate blood components from centrifuged whole blood. Classification: (1) Automatic blood component extractors including sensors, weighting devices, are Class 2 devices; (2) Other devices are Class 1 devices.

Official code: B.1850. Product type: Dye and chemical solution stains. Official classification: Class 1. Dye and chemical solution stains for medical purposes are mixtures of synthetic or natural dyes or nondye chemicals in solutions used in staining cells and tissues for diagnostic histopathology, cytopathology, or hematology.

Official code: B.1860. Product type: Immunohistochemistry reagents and kits 1,2,. Official classification: Class 3. Immunohistochemistry test systems (IHC's) are in vitro diagnostic devices consisting of polyclonal or monoclonal antibodies labeled with directions for use and performance claims, which may be packaged with ancillary reagents in kits. Their intendeduse is to identify, by immunological techniques, antigens in tissues or cytologic specimens. Similardevices intended for use with flow cytometry devices are not considered IHC's. Classification: (1)Class 1 devices used after the primary diagnosis of tumor (neoplasm) has been made by conventional histopathology using nonimmunologic histochemical stains,such as hematoxylin and eosin. Examples of class I IHC's are differentiation markers that are used as adjunctive tests to subclassify tumors, such askeratin. (2) Class 2 devices intended for the detection and/or measurement of certain target analytes inorder to provide prognostic or predictive data that are not directly confirmed by routine histopathologic internal and external control specimens. These IHC's provide the pathologist with information that is ordinarily reported as independent diagnostic information to the ordering clinician, and the claims associated with these data are widely accepted and supported by valid scientific evidence. Examples of class 2 IHC's are those intended for semiquantitative measurement of an analyte, such as hormone receptors in breast cancer. (3) Class 3 devices intended for any use not described in paragraphs (1) or (2) of this section.

Official code: B.1865. Product type: Cervical intraepithelial neoplasia (CIN) test system. Official classification: Class 2. A cervical intraepithelial neoplasia (CIN) test system is a device usedto detect a biomarker associated with CIN in human tissues. The device is indicated as an adjunct test and not to be used as a stand-alone device. The test results must be interpreted in the context of the patient's clinical history including, but not limited to, prior and current cervical biopsy results, Papanicolaou (Pap) test results, human papillomavirus (HPV) test results, and morphology on hematoxylin and eosin (H&E) stained sections. This device is not intended to detect the presence of HPV.

Official code: B.1866. Product type: Lynch Syndrometest systems. Official classification: Class 2. Lynch syndrome test systems are in vitro diagnostic tests for use with tumor tissue to identify previously diagnosed cancer patients at risk for having Lynch syndrome.

Official code: B.2220. Product type: Synthetic cell and tissue culture media and components. Official classification: Class 1. Synthetic cell and tissue culture media and components are substances that are composed entirely of defined components (e.g., amino acids, vitamins, inorganic salts, etc.) that are essential for the survival and development of cell lines of humans and other animals.

Official code: B.2260. Product type: Chromosome culture kit. Official classification: Class 1. A chromosome culture kit is a device containing the necessary ingredients (e.g.,Minimum Essential Media (MEM) of McCoy's 5A culture media, phytohemagglutinin, fetal calf serum, antibiotics, and heparin)used to culture tissues for diagnosis of congenital chromosome abnormalities.

Official code: B.2280. Product type: Cultured animal and human cells. Official classification: Class 1. Cultured animal and human cells are in vitro cultivated cell lines from the tissue of humans or other animals which are usedin various diagnostic procedures, particularly diagnostic virology and cytogenetic studies.

Official code: B.2360. Product type: Mycoplasma detection media and components. Official classification: Class 1. Mycoplasma detection media and components are used to detect and isolate mycoplasma pleuropneumonia-like organisms (PPLO), a common microbial contaminant in cell cultures.

Official code: B.2875. Product type: Balanced salt solutions or formulations. Official classification: Class 1. A balanced salt solution or formulation is a defined mixture of salts and glucose in a simple medium. This device is includedas a necessary component of most cell culture systems. This media component controls for pH, osmotic pressure, energy source, and inorganic ions.

Official code: B.3700. Product type: Whole slide imaging system. Official classification: Class 2. The whole slide imaging system is an automated digital slide creation, viewing, and management system intended as an aid to the pathologist to review and interpret digital images of pathology slides.

Official code: B.4020. Product type: Analyte specific reagents1,. Official classification: Class 2,3. (a)Analyte specific reagents (ASR's) are antibodies, both polyclonal and monoclonal, specific receptor proteins, ligands, nucleic acid sequences, and similar reagents which, through specific binding or chemical reaction with substances in a specimen, are intended for use in a diagnostic application for identification and quantification of an individual chemical substance or ligand in biological specimens. ASR's that otherwise fall within this definition are not within the scope when they are sold to:(1) In vitro diagnostic manufacturers; or(2) Organizations that use the reagents to make tests for purposes other than providing diagnostic information to patients and practitioners, e.g., forensic, academic, research, and other nonclinical laboratories. (b)Classification: (1) Class 1;(2) Class 2 devices used in blood banking tests;(e.g., certain cytomegalovirus tests, serological tests, and non-spirochete tests for treponema pallidum).(3) Class 3 (i) The analyte is intended as a component in a test intended for use in the diagnosis of a contagious condition that is highly likely to result in a fatal outcome and prompt, accurate diagnosis offers the opportunity to mitigate the public health impact of the condition (e.g., human immunodeficiency virus (HIV/AIDS)or tuberculosis (TB)severe acute respiratory syndrome (SARS) or hepatitis; or (ii) The analyte is intended as a component in a test intended for use in donor screening for conditions for which TFDA has recommended or required testing in order to safeguard the blood supply or establish the safe use of blood and blood products (e.g., tests for hepatitis or tests for identifying blood groups). (c)Devices for the following intended use should refer to other TFDA regulations including. (1) Devices intended to use in the diagnosis of a contagious condition that is highly likely to result in a fatal outcome and prompt, accurate diagnosis offers the opportunity to miti-gate the public health. (2) devices intended as a component in a test intended for use in donor screening for conditions for which TFDA has recommended or required testing in order to safeguard the blood supply or establish the safe use of blood and blood products.

Official code: B.4400. Product type: Enzyme preparations. Official classification: Class 1. Enzyme preparations are products that are used in the histopathology laboratory for the following purposes:(1) To disaggregate tissues and cells already in established cultures for preparation into subsequent cultures (e.g., trypsin);(2) To disaggregate fluid specimens for cytological examination (e.g.,papain for gastric lavage or trypsin for sputum liquefaction);(3) To aid in the selective staining of tissue specimens (e.g., diastase for glycogen determination).

Official code: B.5200. Product type: Automated cell counter. Official classification: Class 2. An automated cell counter is a fully-automated or semi-automated device used to count red blood cells, white blood cells, or blood platelets using a sample of the patient's peripheral blood(blood circulating in one of the body's extremities, such as the arm). These devices may also measure hemoglobin or hematocrit and may also calculate or measure one or more of the red cell indices (the erythrocyte mean corpuscular volume, the mean corpuscular hemoglobin, or the mean corpuscular hemoglobin concentration). These devices may use either an electronic particle counting method or an optical counting method.

Official code: B.5220. Product type: Automated differential cell counter. Official classification: Class 2. An automated differential cell counter is adevice used to identify one or more of the formed elements of the blood. The device may also have the capability to flag, count, or classify immature or abnormal hematopoietic cells of the blood, bone marrow,or other body fluids. These devices may combinean electronic particle counting method, optical method, or a flow cytometric method utilizing monoclonal CD (cluster designation) markers. The device includes accessory CD markers.

Official code: B.5240. Product type: Automated blood cell diluting apparatus. Official classification: Class 1. An automated blood cell diluting apparatus is a fully automated or semi-automated device used to make appropriate dilutions of a blood sample for further testing.

Official code: B.5260. Product type: Automated cell-locating device. Official classification: Class 2. An automated cell-locating device is a device used to locate blood cells ona peripheral blood smear, allowing the operator to identify and classify each cell according to type. (Peripheral blood is blood circulating in one of the body's extremities, such as the arm.)

Official code: B.5300. Product type: Red cell indices device. Official classification: Class 2. A red cell indices device, usually part of a larger system, calculates or directly measures the erythrocyte mean corpuscular volume (MCV), the mean corpuscular hemoglobin (MCH), and the mean corpuscular hemoglobin concentration (MCHC). The red cell indices are used for the differential diagnosis of anemias.

Official code: B.5350. Product type: Microsedimentation centrifuge. Official classification: Class 1. A microsedimentation centrifuge is a device used to sediment red cells for the microsedimentation rate test.

Official code: B.5400. Product type: Coagulation instrument. Official classification: Class 2. A coagulation instrument is an automated or semiautomated device used to determine the onset of clot formation for in vitro coagulation studies.

Official code: B.5425. Product type: Multipurpose system for in vitro coagulation studies. Official classification: Class 2. A multipurpose system for in vitro coagulation studies is a device consisting of one automated orsemiautomated instrument and its associated reagents and controls. The system is used to perform a series of coagulation studies and coagulation factor assays.

Official code: B.5600. Product type: Automated hematocrit instrument. Official classification: Class 2. An automated hematocrit instrument is a fully automated or semi-automated device which may or may not be part of a larger system. This device measures the packed red cell volume of a blood sample to distinguish normal from abnormal states, such as anemia and erythrocytosis (an increase in the number of red cells).

Official code: B.5620. Product type: Automated hemoglobin system. Official classification: Class 2. An automated hemoglobin system is a fully automated or semi-automated device which may or may not be part of a larger system. The generic type of device consists of the reagents, calibrators, controls, and instrumentation used to determine the hemoglobin content of human blood.

Official code: B.5680. Product type: Automated heparin analyzer. Official classification: Class 2. An automated heparin analyzer is a device used to determine the heparin level in a blood sample by mixing the sample with protamine (a heparin-neutralizing substance) and determining photometrically the onset of air-activated clotting. The analyzer also determines the amount of protamine necessary to neutralize the heparin in the patient's circulation.

Official code: B.5700. Product type: Automated platelet aggregation system. Official classification: Class 2. An automated platelet aggregation system is a device used to determine changes in platelet shape and platelet aggregation following the addition of an aggregating reagent to a platelet-rich plasma.

Official code: B.5800. Product type: Automated sedimentation rate device. Official classification: Class 1. An automated sedimentation rate device is an instrument that measures automatically the erythrocyte sedimentation rate in whole blood. Because an increased sedimentation rate indicates tissue damage or inflammation, the erythrocyte sedimentation rate device is useful in monitoring treatment of a disease.

Official code: B.5850. Product type: Automated slide spinner. Official classification: Class 1. An automated slide spinner is a device that prepares automatically a blood film on a microscope slide using a small amount of peripheral blood (blood circulating in one of the body's extremities, such as the arm).

Official code: B.5950. Product type: Blood volume measuring device. Official classification: Class 2. A blood volume measuring device is a manual, semiautomated, or automated system that is used to calculate the red cell mass, plasma volume, and total blood volume.

Official code: B.6100. Product type: Bleeding time device. Official classification: Class 1. A bleeding time device is a device, usually employing two spring-loaded blades, that produces two small incisions in the patient's skin. The length of time required for the bleeding to stop is a measure of the effectiveness of the coagulation system, primarily the platelets.

Official code: B.6150. Product type: Capillary blood collection tube. Official classification: Class 1. A capillary blood collection tube is a plain or heparinized glass tube of very small diameter used to collect blood by capillary action.

Official code: B.6160. Product type: Manual blood cell counting device. Official classification: Class 1. A manual blood cell counting device is a device used to count red blood cells, white blood cells, or blood platelets.

Official code: B.6400. Product type: Hematocrit measuring device. Official classification: Class 1. A hematocrit measuring device is a system consisting of instruments, tubes, racks, and a sealer and a holder.The device is used to measure the packed red cell volume in blood to determine whether the patient's total red cell volume is normal or abnormal. Abnormal states include anemia (an abnormally low total red cell volume) and erythrocytosis (an abnormally high total red cell mass). The packed red cell volume is produced by centrifuging a given volume of blood.

Official code: B.6550. Product type: Occult blood test. Official classification: Class 2. An occult blood test is a device used to detect occult blood in urine or feces. (Occult blood is blood present in such small quantities that it can be detected only by chemical tests of suspected material, or by microscopic or spectroscopic examination.)

Official code: B.6600. Product type: Osmotic fragility test. Official classification: Class 1. An osmotic fragility test is a device used to determine the resistance of red blood cells to hemolysis (destruction) in varying concentrations of hypotonic saline solutions.

Official code: B.6650. Product type: Platelet adhesion test. Official classification: Class 2. A platelet adhesion test is a device used to determine in vitro platelet function.

Official code: B.6675. Product type: Platelet aggregometer. Official classification: Class 2. A platelet aggregometer is a device, used to determine changes in platelet shape and platelet aggregation following the addition of an aggregating reagent to a platelet rich plasma.

Official code: B.6700. Product type: Erythrocyte sedimentation rate test. Official classification: Class 1. An erythrocyte sedimentation rate test is a device that measures the length of time required for the red cells in a blood sample to fall a specified distance or a device that measures the degree of sedimentation taking place in a given length of time. An increased rate indicates tissue damage or inflammation.

Official code: B.7010. Product type: Flow cytometric test for hematopoietic neoplasms. Official classification: Class 2. A flow cytometric test for hematopoietic neoplasms is a device that consists of reagents for immunophenotyping of human cells in relation to the level of expression, antigen density, and distribution of specific cellular markers. These reagents are used as an aid in the differential diagnosis or monitoring of hematologic abnormalities inpatients having or suspected of having hematopoietic neoplasms. The results should be interpreted by a pathologist or equivalent professional in conjunction with other clinical and laboratory findings.

Official code: B.7040. Product type: Adenosine triphosphate release assay. Official classification: Class 1. An adenosine triphosphate release assay is a device that measures the release of adenosine triphosphate (ATP) from platelets following aggregation. This measurement is made on platelet-rich plasma using a photometer and a luminescent firefly extract. Simultaneous measurements of platelet aggregation and ATP release are used to evaluate platelet function disorders.

Official code: B.7060. Product type: Antithrombin III assay. Official classification: Class 2. An antithrombin III assay is a device that is used to determine the plasma level of antithrombin III (a substance which actswith the anticoagulant heparin to prevent coagulation). This determination is used to monitor the administration of heparin in the treatment of thrombosis. The determination may also be used in the diagnosis of thrombophilia (a congenital deficiency of antithrombin III).

Official code: B.7100. Product type: Red blood cell enzyme assay. Official classification: Class 2. Red blood cell enzyme assay is a device used to measure the activity in red blood cells of clinically important enzymatic reactions and their products, such as pyruvate kinase or 2,3-diphosphoglycerate. A red blood cell enzyme assay is used to determine the enzyme defects responsible for a patient's hereditary hemolytic anemia.

Official code: B.7140. Product type: Activated whole blood clotting time tests. Official classification: Class 2. An activated whole blood clotting time tests is a device, used to monitor heparin therapy for the treatment of venous thrombosis or pulmonary embolism by measuring the coagulation time of whole blood.

Official code: B.7250. Product type: Erythropoietin assay. Official classification: Class 2. A erythropoietin assay is a device that measures the concentration of erythropoietin (an enzyme that regulates the productionof red blood cells) in serum or urine. This assay provides diagnostic information for the evaluation of erythrocytosis (increased total red cell mass) and anemia.

Official code: B.7275. Product type: Euglobulin lysis time tests. Official classification: Class 2. A euglobulin lysis time test is a device that measures the length of time required for the lysis (dissolution) of a clot formed from fibrinogen in the euglobulin fraction (that fraction of the plasma responsible for the formation of plasmin, a clot lysing enzyme). This test evaluates natural fibrinolysis (destruction of a blood clot after bleeding has been arrested). The test also will detect accelerated fibrinolysis.

Official code: B.7280. Product type: Factor V Leiden DNA mutation detection systems. Official classification: Class 2. Factor V Leiden deoxyribonucleic acid (DNA) mutation detection systems are devices that consist of different reagents and instruments which include polymerase chain reaction (PCR) primers, hybridization matrices, thermal cyclers, imagers, and software packages. The detection of the Factor V Leiden mutation aids in the diagnosis of patients with suspected thrombophilia.

Official code: B.7290. Product type: Factor deficiency test. Official classification: Class 2. A factor deficiency test is a device used to diagnose specific coagulation defects, to monitor certain types of therapy, to detect coagulation inhibitors, and to detect a carrier state (a person carrying both a recessive gene for a coagulation factor deficiency such as hemophilia and the corresponding normal gene).

Official code: B.7300. Product type: Fibrin monomer paracoagulation test. Official classification: Class 2. A fibrin monomer paracoagulation test is a device used to detect fibrin monomer in the diagnosis of disseminated intravascular coagulation (nonlocalized clotting within a blood vessel) or in the differential diagnosis between disseminated intravascular coagulation and primary fibrinolysis (dissolution of the fibrin in a blood clot).

Official code: B.7320. Product type: Fibrinogen/fibrin degradation products assay. Official classification: Class 2. A fibrinogen/fibrin degradation products assay is a device used to detect and measure fibrinogen degradation products and fibrin degradation products (protein fragments produced by the enzymatic action of plasmin on fibrinogen and fibrin) as an aid in detecting the presence and degree ofintravascular coagulation and fibrinolysis (the dissolution of the fibrin in a blood clot) and in monitoring therapy for disseminated intravascular coagulation (nonlocalized clotting in the blood vessels).

Official code: B.7340. Product type: Fibrinogen determination system. Official classification: Class 2. A fibrinogen determination system is a device that consists of the instruments, reagents, standards, and controls used to determine the fibrinogen levels in disseminated intravascular coagulation (nonlocalized clotting within the blood vessels) and primary fibrinolysis (the dissolution of fibrin in a blood clot).

Official code: B.7360. Product type: Erythrocytic glucose-6- phosphate dehydrogenase assay. Official classification: Class 2. An erythrocytic glucose-6-phosphate dehydrogenase assay is a device used to measure the activity of the enzyme glucose-6- phosphate dehydrogenase or of glucose-6-phosphate dehydrogenase isoenzymes. The results of this assay are used in the diagnosis and treatment of nonspherocytic congenital hemolytic anemia or drug-induced hemolytic anemia associated with a glucose-6- phosphate dehydrogenase deficiency. This generic device includes assays based on fluorescence, electrophoresis, methemoglobin reduction, catalase inhibition, and ultraviolet kinetics.

Official code: B.7375. Product type: Glutathione reductase assay. Official classification: Class 2. A glutathione reductase assay is a device used to determine the activity of the enzyme glutathione reductase in serum, plasma, or erythrocytes by such techniques as fluorescence and photometry. The results of this assay are used in the diagnosis of liverdisease, glutathione reductase deficiency, or riboflavin deficiency.

Official code: B.7400. Product type: Hemoglobin A2 assay. Official classification: Class 2. A hemoglobin A2 assay is a device used to determine the hemoglobin A2content of human blood. The measurement of hemoglobin A2 is used in the diagnosis of the thalassemias (hereditary hemolytic anemias characterized by decreased synthesis of one or more types of hemoglobin polypeptide chains).

Official code: B.7415. Product type: Abnormal hemoglobin assay. Official classification: Class 2. An abnormal hemoglobin assay is a device consisting of the reagents, apparatus, instrumentation, and controls necessary to isolate and identify abnormal genetically determined hemoglobin types.

Official code: B.7425. Product type: Carboxyhemoglobin assay. Official classification: Class 2. A carboxyhemoglobin assay is a device used to determine the carboxyhemoglobin (the compound formed when hemoglobin is exposed to carbon monoxide) content of human blood as an aid in the diagnosis of carbon monoxide poisoning. This measurement may be made using methods such as spectroscopy, colorimetry, spectrophotometry, and gasometry.

Official code: B.7440. Product type: Electrophoretic hemoglobin analysis system. Official classification: Class 2. A hemoglobin electrophoresis analysissystem is a device that electrophoretically separates and identifies normal and abnormal hemoglobin types as an aid in the auxiliary diagnosis of anemia or erythrocytosis (increased total red cell mass) due to a hemoglobin abnormality.

Official code: B.7455. Product type: Fetal hemoglobin assay. Official classification: Class 2. A fetal hemoglobin assay is a device that is used to determine the presence and distribution of fetal hemoglobin (hemoglobinF) in red cells or to measure the amount of fetal hemoglobin present. The assay may be used to detect fetal red cellsin the maternal circulation or to detect the elevated levels of fetal hemoglobin exhibited in cases of hemoglobin abnormalities such as thalassemia (a hereditary hemolytic anemia characterized by a decreased synthesis of one or more types of hemoglobin polypeptide chains). The hemoglobin determination may be made by methods such as electrophoresis, alkali denaturation, column chromatography, or radial immunodiffusion.

Official code: B.7470. Product type: Glycosylated hemoglobin assay. Official classification: Class 2. A glycosylated hemoglobin assay is a device usedto measure the glycosylated hemoglobins (A1a, A1b, and A1c) in a patient's blood by a column chromatographic procedure. Measurement of glycosylated hemoglobin is used to assess the level of control of a patient's diabetes and to determine the proper insulin dosage for a patient. Elevated levels of glycosylated hemoglobin indicate uncontrolled diabetes in a patient.

Official code: B.7490. Product type: Sulfhemoglobin assay. Official classification: Class 2. A sulfhemoglobin assay is a device consisting of the reagents, calibrators, controls, and instrumentation used todetermine the sulfhemoglobin (a compound of sulfur and hemoglobin) content of human blood as an aid in the diagnosis of sulfhemoglobinemia (presence of sulfhemoglobin in the blood due to drug administration or exposure to a poison). This measurement may be made using methods such as spectroscopy, colorimetry, spectrophotometry, or gasometry.

Official code: B.7500. Product type: Whole blood hemoglobin assays. Official classification: Class 2. A whole blood hemoglobin assay is a device consisting or reagents, calibrators, controls, or photometric or spectrophotometric instrumentation used to measure the hemoglobin content of whole blood for the detection of anemia. This generic device category does not include automated hemoglobin systems.

Official code: B.7525. Product type: Heparin assay. Official classification: Class 2. A heparin assay is a device used to determine the level of the anticoagulant heparin in the patient's circulation. These assays are quantitative clotting time procedures using the effect of heparin on activated coagulation factor X (Stuart factor) or procedures based on the neutralization of heparin by protamine sulfate (a protein that neutralizes heparin).

Official code: B.7660. Product type: Leukocyte alkaline phosphatase test. Official classification: Class 1. A leukocyte alkaline phosphatase test is a device used to identify the enzyme leukocyte alkaline phosphatase in neutrophilic granulocytes (granular leukocytes stainable by neutral dyes). The cytochemical identification of alkaline phosphatase depends on the formation of blue granules in cells containing alkaline phosphatase. The results of this test are used to differentiate chronic granulocytic leukemia (a malignant disease characterized by excessive overgrowth of granulocytes in the bone marrow) and reactions that resemble true leukemia, such as those occurring in severe infections and polycythemia (increased total red cell mass).

Official code: B.7675. Product type: Leukocyte peroxidase test. Official classification: Class 1. A leukocyte peroxidase test is a device used to distinguish certain myeloid cells derived from the bone marrow, i.e., neutrophils, eosinophils, and monocytes, from lymphoid cells of the lymphatic system and erythroid cells of the red blood cell series base on their peroxidase activity as evidenced by staining. The results of this test are used in the differential diagnosis of the leukemias.

Official code: B.7695. Product type: Platelet factor 4 radioimmunoassay. Official classification: Class 2. A platelet factor 4 radioimmunoassay is a device used to measure the level of platelet factor 4, a protein released during platelet activation by radioimmunoassay. This device measures platelet activation, which may indicate a coagulation disorder, such as myocardial infarction or coronary artery disease.

Official code: B.7720. Product type: Prothrombin consumption test. Official classification: Class 2. A prothrombin consumption tests is a device that measures the patient's capacity to generate thromboplastin in the coagulation process. The test also is an indirect indicator of qualitative or quantitative platelet abnormalities. It is ascreening test for thrombocytopenia (decreased number of blood platelets) and hemophilia A and B.

Official code: B.7735. Product type: Prothrombin-proconvertin test and thrombotest. Official classification: Class 2. The prothrombin-proconvertin test and thrombotest are devices used in the regulation of coumarin therapy (administration of a coumarin anticoagulant such as sodium warfarin in the treatment of venous thrombosis and pulmonary embolism) and as a diagnostic test in conjunction with, or in place of, the Quick prothrombin time test to detect coagulation disorders.

Official code: B.7750. Product type: Prothrombin time test. Official classification: Class 2. A prothrombin time test is a device used as a general screening procedure for the detection of possible clotting factor deficiencies in the extrinsic coagulation pathway, which involves the reaction between coagulationfactors III and VII, and to monitor patients receiving coumarin therapy (the administration of one of the coumarin anticoagulants in the treatment of venous thrombosis or pulmonary embolism).

Official code: B.7825. Product type: Sickle cell test. Official classification: Class 2. A sickle cell test is a device used to determine the sickle cell hemoglobin content of human blood to detect sickle cell trait or sickle cell diseases.

Official code: B.7875. Product type: Thrombin time test. Official classification: Class 2. A thrombin time test is a device used to measure fibrinogen concentration and detect fibrin or fibrinogen splitproducts for the evaluation of bleeding disorders.

Official code: B.7900. Product type: Thromboplastin generation test. Official classification: Class 1. A thromboplastin generation test is a device used to detect and identify coagulation factor deficiencies and coagulation inhibitors.

Official code: B.7925. Product type: Partial thromboplastin time tests. Official classification: Class 2. A partial thromboplastin time test is a device used for primary screening for coagulation abnormalities, for evaluation of the effect of therapy on procoagulant disorders, and as an assay for coagulation factor deficiencies of the intrinsic coagulation pathway

Official code: B.8100. Product type: Bothrops atrox reagent. Official classification: Class 2. A Bothrops atrox reagent is a device made from snake venom and used to determine blood fibrinogen levels to aid in the evaluation of disseminated intravascular coagulation (nonlocalized clotting in the blood vessels) in patients receiving heparin therapy (the administration of the anticoagulant heparin in the treatment of thrombosis) or as an aid in the classification of dysfibrinogenemia (presence in the plasma of functionally defective fibrinogen).

Official code: B.8150. Product type: Calibrator for cell indices. Official classification: Class 2. A calibrator for cell indices is a device that approximates whole blood or certain blood cells and that is used to set an instrument intended to measure mean cell volume (MCV), mean corpuscular hemoglobin (MCH), and mean corpuscular hemoglobin concentration (MCHC), or other cell indices. It is a suspension of particles or cells whose size, shape, concentration, and other characteristics have been precisely and accurately determined.

Official code: B.8165. Product type: Calibrator for hemoglobin or hematocrit measurement. Official classification: Class 2. A calibrator for hemoglobin or hematocrit measurement is a device that approximates whole blood, red blood cells, or a hemoglobin derivative and that is used to set instruments intended to measure hemoglobin, the hematocrit, or both. Itis a material whose characteristics have been precisely and accurately determined.

Official code: B.8175. Product type: Calibrator for platelet counting. Official classification: Class 2. A calibrator for platelet counting is a device that resembles platelets in plasma or whole blood and that is used to set a platelet counting instrument. It is a suspension of particles or cells whose size, shape concentration, and other characteristics havebeen precisely and accurately determined.

Official code: B.8185. Product type: Calibrator for red cell and white cell counting. Official classification: Class 2. A calibrator for red cell and white cell counting is a device that resembles red or white blood cells and that is used to set instruments intended to count red cells, white cells, or both. It is a suspension of particles or cells whose size, shape, concentration,and other characteristics have been precisely and accurately determined.

Official code: B.8200. Product type: Blood cell diluent. Official classification: Class 1. A blood cell diluent is a device used to dilute blood for further testing, such as blood cell counting.

Official code: B.8500. Product type: Lymphocyte separation medium. Official classification: Class 1. A lymphocyte separation medium is a device used to isolate lymphocytes from whole blood.

Official code: B.8540. Product type: Red cell lysing reagent. Official classification: Class 1. A red cell lysing reagent is a device used to lyse (destroy) red blood cells for hemoglobin determinations or aid in the counting of white blood cells.

Official code: B.8625. Product type: Hematology quality control mixture. Official classification: Class 2. A hematology quality control mixture is a device used to ascertain the accuracy and precision of manual, semiautomated, and automated determinations of cell parameters such as white cell count (WBC), red cell count (RBC), platelet count (PLT), hemoglobin, hematocrit (HCT), mean corpuscular volume (MCV), mean corpuscular hemoglobin (MCH), and mean corpuscular hemoglobin concentration (MCHC).

Official code: B.8950. Product type: Russell viper venom reagent. Official classification: Class 1. Russell viper venom reagent is a device used to determine the cause of an increase in the prothrombin time.

Official code: B.9050. Product type: Blood bank supplies. Official classification: Class 1. Blood bank supplies are general purpose devices intended for in vitro use in blood banking. This generic type of device includes products such as blood bank pipettes, blood grouping slides, blood typing tubes, blood typing racks,cold packs for antisera reagents, and tube stripper.

Official code: B.9100. Product type: Empty container for the collection and processing of blood and blood components. Official classification: Class 2. An empty container for the collection and processing of blood and blood components is a device intended for medical purposes that is an empty plastic bag or plastic or glass bottle used to collect, store, or transfer blood and blood components for further processing.

Official code: B.9125. Product type: Vacuum-assisted blood collection system. Official classification: Class 1. A vacuum-assisted blood collection system is a device intended for medical purposes that uses a vacuum to draw blood for subsequent reinfusion.

Official code: B.9145. Product type: Processing system for frozen blood. Official classification: Class 2. A processing system for frozen blood is a device usedto glycerolize red blood cells prior to freezing to minimize hemolysis (disruption of the red cell membrane accompanied by the release of hemoglobin) due to freezing and thawing of red blood cells and to deglycerolize and wash thawed cells for subsequent reinfusion.

Official code: B.9165. Product type: Blood establishment computer software. Official classification: Class 2. Blood establishment computer software (BECS) is a device used in the manufacture of blood and blood components to assist in the prevention of disease in humans by identifying ineligible donors, bypreventing the release of unsuitable blood and blood components for transfusion or for further manufacturing into products for human treatment or diagnosis, by performing compatibility testing between donor and recipient, or by performing positive identification of patients and blood components at the point of transfusion to prevent transfusion reactions. This generic type of device may include a BECS accessory, a device intended for use with BECS to augment the performance of the BECS or to expand or modify its indications for use.

Official code: B.9175. Product type: Automated blood grouping and antibody test system. Official classification: Class 2. An automated blood grouping and antibody test system is a device used to group erythrocytes (red blood cells) and to detect antibodies to blood group antigens.

Official code: B.9195. Product type: Blood mixing devices and blood weighing devices. Official classification: Class 1. A blood mixing device is a device intended for medical purposes that is used to mix blood or blood components by agitation. A blood weighing device is a device intended for medical purposes that is used toweigh blood or blood components as they are collected.

Official code: B.9205. Product type: Blood and plasma warming device. Official classification: Class 2,3. (a)Nonelectromagnetic blood or plasma warming device.(1)Identification: A nonelectromagnetic blood and plasma warming device is a device that warms blood or plasma, by means other than electromagnetic radiation, prior to administration. (2)Classification: Class 2. (b)Electromagnetic blood and plasma warming device.(1)Identification. An electromagnetic blood and plasma warming device is a device that employs electromagnetic radiation (radiowaves or microwaves) to warm a bag or bottle of blood or plasma prior to administration. (2) Classification: Class 3.

Official code: B.9225. Product type: Cell-freezing apparatus and reagents for in vitro diagnostic use. Official classification: Class 1. Cell-freezing apparatus and reagentsfor in vitro diagnostic use are devices used to freeze human red blood cells for in vitro diagnostic use.

Official code: B.9245. Product type: Automated blood cell separator. Official classification: Class 2. An automated blood cell separator is a device that uses a centrifugal or filtration separation principle toautomatically withdraw whole blood from a donor, separate the whole blood into blood components, collect one or more of the blood components, and return to the donor the remainder of the whole blood and blood components. The remainder of blood components is intended for transfusion or further manufacturing use. The device is operated by centrifugal or filtration separation principle. The bowlof the separator is reusable or for single use.

Official code: B.9275. Product type: Blood bank centrifuge for in vitro diagnostic use. Official classification: Class 1. A blood bank centrifuge for in vitro diagnostic use is a device used only to separate blood cells for further diagnostic testing.

Official code: B.9285. Product type: Automated cell-washing centrifuge for immuno- hematology. Official classification: Class 2. An automated cell-washing centrifuge for immuno-hematology is a device used to separate and prepare cells and sera for further in vitro diagnostic testing.

Official code: B.9300. Product type: Automated Coombs test systems. Official classification: Class 2. An automated Coombs test system is a device used to detect and identify antibodies in patient sera or antibodies bound to red cells. The Coombs test is used for the diagnosis of hemolytic disease of the newborn, and autoimmune hemolytic anemia. The test is also used in crossmatching and in investigating transfusion reactions and drug-induced red cell sensitization.

Official code: B.9320. Product type: Copper sulfate solution for specific gravity determinations. Official classification: Class 1. A copper sulfate solution for specific gravity determinations is a device used to determine whether the hemoglobin content ofa potential donor's blood meets the required level (12.5 grams per 100 milliliters of blood for women and 13.5 grams per 100 milliliters of blood for men).

Official code: B.9400. Product type: Stabilized enzyme solution. Official classification: Class 2. A stabilized enzyme solution is a reagent intended for medical purposes that is used to enhance the reactivity of red blood cells with certain antibodies, including antibodies that are not detectable by other techniques. These enzyme solutions include papain, bromelin, ficin, and trypsin.

Official code: B.9550. Product type: Lectins and protectins. Official classification: Class 1. Lectins and protectins are proteins derived from plants and lower animals that cause cell agglutination in the presence of certain antigens. These substances are used to detect blood group antigens for in vitro diagnostic purposes.

Official code: B.9575. Product type: Environmental chamber for storage of platelet concentrate. Official classification: Class 1. An environmental chamber for storage of platelet concentrate is a device used to hold platelet-rich plasma within a preselected temperature range.

Official code: B.9600. Product type: Potentiating media for in vitro diagnostic use. Official classification: Class 1. Potentiating media for in vitro diagnostic use is media, such as bovine albumin,that are used to suspend red cells and to enhance cell reactions for antigen-antibody testing.

Official code: B.9650. Product type: Quality control kit for blood banking reagents. Official classification: Class 2. A quality control kit for blood banking reagents is a device that consists of sera, cells, buffers, andantibodies used to determine the specificity, potency, and reactivity of the cells and reagents used for blood banking.

Official code: B.9700. Product type: Blood storage refrigerator and blood storage freezer. Official classification: Class 1. A blood storage refrigerator and a blood storage freezer are devices intended for medical purposes that are used to preserve blood and blood products by storing them at cold or freezing temperatures.

Official code: B.9750. Product type: Heat-sealing device. Official classification: Class 1. A heat-sealing device is a device intended for medical purposes that uses heat to seal plastic bags containing blood or blood components.

Official code: B.9875. Product type: Transfer set. Official classification: Class 2. A transfer set is a device intended for medical purposes that consists of a piece of tubing with suitable adaptors used to transfer blood or plasma from one container to another.

Official code: B.9900. Product type: Cord blood processing system and storage container. Official classification: Class 2. A cord blood processing system and storage container is a device intended for use in the processing and the storage of cord blood. This device is a functionally closed processing system that includes containers, other soft goods, and a centrifugation system for cord blood concentration, and a final container for the cryopreservation and the storage of a cord blood product.

Official code: B.9999. Product type: Others (Hematology and Pathology Devices) 1,. Official classification: Class 2,3. The products excluded from the above-classification are adopted in this classification and specified by the central competent health authority.

Official code: C.0001. Product type: Enterovirus 71 serological reagents. Official classification: Class 2. Enterovirus 71 serological reagents are devices that consist of antigens and antisera used to detect serum enterovirus antibodies in serological tests. Additionally, some of these reagents consist of enterovirus antisera conjugated with a fluorescent dye which used to detect enterovirus from clinical specimens or from cultured isolates derived from clinical specimens. The identification aids in the diagnosis of enterovirus infections and provides epidemiological information on diseases caused by these viruses. Enterovirus cause illnesses such as hand, foot and mouth diseases which in its serious form affect the central nervous system resulting in encephalitis, viral meningitis or/and paralysis.

Official code: C.0002. Product type: Dengue virus serological reagents. Official classification: Class 2. Dengue virus serological reagents are devices that consist of antigens and/or antibodies for the detection of dengue antigens or antibodies in serum of patients with signs or symptoms of dengue fever or dengue haemorrhagic fever. This detection aids in diagnosis of diseases caused by dengue virus and provides epidemiological information on diseases caused by these viruses.

Official code: C.0003. Product type: Helicobacter spp. serological reagents. Official classification: Class 1. Helicobacter spp. serological reagents are devices consist of helicobacter antisera conjugated with a fluorescent dye which used to detect Helicobacter pylori from clinical specimens or from cultured isolates derived from clinical specimens. This identification aids in the diagnosis of Helicobacter pylori infections and provides epidemiological information on diseases caused by these viruses. Helicobacter pylori causes illnesses such as stomach ulcers, stomach inflammation (gastritis) leading to upper abdominal pain and bleeding.

Official code: C.0004. Product type: Human papillomavirus serological reagents. Official classification: Class 3. Human papillomavirus serological reagents are devices that consist of antigens and antisera used in serological tests to identify Human papillomavirus antibodies in serum. The identification aids in the diagnosis of cervical cancer, identifies immune status of patients, and provides epidemiological information on diseases caused by these viruses.

Official code: C.0005. Product type: Plasmodium spp. serological reagents. Official classification: Class 2. Plasmodium spp. serological reagents are devices that consist of antigens and antisera used in serological tests to detect Plasmodium antibodies in serum. Additionally, some of these reagents consist of Plasmodium antisera conjugated with a fluorescent dye used to identify Plasmodium from clinical specimens. The identification aids in the diagnosis of Plasmodium infections and provides epidemiological information on diseases caused by these viruses. Plasmodium cause human malaria infections, which lead to fever, shiver, headache, muscle pain, arthralgia (joint pain). Untreated or unidentified diseases can cause severe cerebral malaria and fatal renal failure.

Official code: C.1620. Product type: Antimicrobial susceptibility. Official classification: Class 2. An antimicrobial susceptibility test disc is a device that consists of antimicrobic-impregnated paper discs used to measure by a test discdisc-agar diffusion technique or a disc-broth elution technique the in vitro susceptibility of most clinically important bacterial pathogens to antimicrobial agents. In the disc-agar diffusion technique, bacterial susceptibility is ascertained by directly measuring the magnitude of a zone of bacterial inhibition around the disc on an agar surface. The disc-broth elution technique is associated with an automated rapid susceptibility test system and employs a fluid medium in which susceptibility is ascertained by photometrically measuring changes in bacterial growth resulting when antimicrobial material is eluted from the disc into thefluid medium. Test results are used to determine the antimicrobial agent of choice in the treatment of bacterial diseases.

Official code: C.1640. Product type: Antimicrobial susceptibility test powder. Official classification: Class 2. An antimicrobial susceptibility test powder is a device that consists of an antimicrobial drug powder packaged in vialsin specified amounts and intended for use in clinical laboratories for determining in vitro susceptibility of bacterial pathogens to these therapeutic agents. Test results are used to determine the antimicrobial agent of choice in the treatment of bacterial diseases.

Official code: C.1645. Product type: Fully automatedshort- term incubation cycle antimicrobial susceptibility system. Official classification: Class 2. A fully automated short-term incubation cycle antimicrobial susceptibility system is a device that incorporates concentrations of antimicrobial agents into a system for the purpose of determining in vitro susceptibility of bacterial pathogens isolated from clinical specimens. Test results obtained from short-term (less than 16 hours) incubation are used to determine the antimicrobial agent of choice to treat bacterial diseases.

Official code: C.1700. Product type: Culture medium for antimicrobial susceptibility tests. Official classification: Class 2. A culture medium for antimicrobial susceptibility tests is a device intended for medical purposes that consists of any medium capable of supporting the growth of many of the bacterial pathogens that are subject to antimicrobial susceptibility tests. The medium should be free of components known to be antagonistic to the common agents for which susceptibility tests are performed in the treatment of disease.

Official code: C.2160. Product type: Coagulase plasma. Official classification: Class 1. Coagulase plasma is a device that consists of freeze-dried animal or human plasma that is intended for medical purposes to perform coagulase tests primarily on staphylococcal bacteria. When reconstituted, the fluid plasma is clotted by the action of the enzyme coagulase which is produced by pathogenic staphylococci. Test results are used primarily as an aid in the diagnosis of disease caused by pathogenic bacteria belonging to the genus Staphylococcus and provide epidemiological information ondisease caused by these microorganisms.

Official code: C.2170. Product type: Automated colony counter. Official classification: Class 1. An automated colony counter is a mechanical device intended for medical purposes to determine the number of bacterial colonies present on a bacteriological culture medium containedin a petri plate. The number of colonies counted is used in the diagnosis of disease as a measure of the degree of bacterial infection.

Official code: C.2190. Product type: Automated image assessment system for microbial colonies on solid culture media. Official classification: Class 2. An automated image assessmentsystem for microbial colonies on solid culture media is a system that is intended to assess the presence or absence of microbial colonies on solid microbiological culture medium, and to interpret their number, and phenotypic and morphologic characteristics through analysis of two-dimensional digital images as an aid in diagnosis of infectious disease.

Official code: C.2300. Product type: Multipurpose culture medium. Official classification: Class 1. A multipurpose culture medium is a device that consists primarily of liquid or solid biological materials intended for medical purposes for the cultivation and identification of several types of pathogenic microorganisms without the need of additional nutritional supplements. Test results aid in the diagnosis of disease and also provide epidemiological information on diseases caused by these microorganisms.

Official code: C.2320. Product type: Differential culture medium. Official classification: Class 1. A differential culture medium is a device that consists primarily of liquid biological materials intended for medical purposes to cultivate and identify different types of pathogenicmicroorganisms. The identification of these microorganisms is accomplished by the addition of a specific biochemical component(s) to the medium. Microorganisms are identified by a visible change (e.g.,a color change) in a specific biochemical component(s)which indicates that specific metabolic reactions have occurred. Test results aid in the diagnosis of disease and also provide epidemiological information on diseases caused by these microorganisms.

Official code: C.2330. Product type: Enriched culture medium. Official classification: Class 1. An enriched culture medium is a device that consists primarily of liquid or solid biological materials intended for medical purposes to cultivate and identify fastidious microorganisms (those having complex nutritional requirements). The device consists of a relatively simple basal medium enriched by the addition of such nutritional components as blood, blood serum, vitamins, and extracts of plant or animal tissues. The device is used in the diagnosis of disease caused by pathogenic microorganisms and also provides epidemiological information on these diseases.

Official code: C.2350. Product type: Microbiological assay culture medium. Official classification: Class 1. A microbiological assay culture medium is a device that consists primarily of liquid or solid biological materials intended for medical purposes to cultivate selected test microorganisms in order to measure by microbiological procedures the concentration in a patient's serum of certain substances, such as amino acids, antimicrobial agents, and vitamins. The concentration of these substances is measured by their ability to promote or inhibit the growth of the test organism in the inoculated medium. Test results aid in the diagnosis of disease resulting from either deficient or excessive amounts of these substances in a patient's serum. Tests results may also be used to monitor the effects of the administration of certain antimicrobial drugs.

Official code: C.2360. Product type: Selective culture medium. Official classification: Class 1. A selective culture medium is a device that consists primarily of liquid or solid biological materials intended for medical purposes to cultivate and identify certain pathogenic microorganisms. The device contains one or more components that suppress the growth of certain microorganisms while either promoting or not affecting the growth of other microorganisms. The device aids in the diagnosis of disease caused by pathogenic microorganisms and also provides epidemiological information on these diseases.

Official code: C.2390. Product type: Transport culture medium. Official classification: Class 1. A transport culture medium is a device that consists of a semisolid, usually non-nutrient, medium that maintains the viability of suspected pathogens contained in patient specimens while in transit from the specimen collection area to the laboratory. Thedevice aids in the diagnosis of disease caused by pathogenic microorganisms and also provides epidemiological information on these diseases.

Official code: C.2410. Product type: Culture medium for pathogenic Neisseria spp. Official classification: Class 2. A culture medium for pathogenicNeisseria spp. is a device that consists primarily of liquid or solid biological materials used to cultivate and identify pathogenic Neisseria spp. The identification aids in the diagnosis of disease caused by bacteria belonging to the genusNeisseria, such as epidemic cerebrospinal meningitis, other meningococcal disease, and gonorrhea, and also provides epidemiological information on these microorganisms.

Official code: C.2420. Product type: Oxidase screening test for. Official classification: Class 3. An oxidase screening test for gonorrhea is an in vitro device that consists of the articles intended to identify by chemicalreaction, gonorrheacytochrome oxidase, an oxidizing enzyme that is associated with certain bacteria includingNeisseria gonorrhoeae. A sample of a male's urethral discharge is obtained on a swab which is placed into a wetting agent containing an ingredient that will reactwith cytochrome oxidase. When cytochrome oxidase is present, the swab turnsa dark purple color within 3 minutes. Because it is unlikely that cytochrome oxidase-positive organisms other thanNeisseria gonorrhoeae are present in the urethral discharge of males, the identification of cytochrome oxidase with this device indicates presumptive infection of the patient with the causative agent of gonorrhea.

Official code: C.2450. Product type: Supplement for culture media. Official classification: Class 1. A supplement for culture media is a device, such as a vitamin or sugar mixture, that is added to a solid or liquid basal culture medium to produce a desired formulation and that is intended for medical purposes to enhance the growth of fastidious microorganisms (those having complex nutritional requirements). This device aids in the diagnosis of diseases caused by pathogenic microorganisms.

Official code: C.2480. Product type: Quality control kit for culture media. Official classification: Class 1. A quality control kit for culture media is a device that consists of paper discs (or other suitable materials), each impregnated with a specified, freeze-dried, viable microorganism, intended for medical purposes to determine if a given culture medium is able to support the growth of that microorganism. The device aids in the diagnosis of disease caused by pathogenic microorganisms and also provides epidemiological information on these diseases.

Official code: C.2500. Product type: Microtiter diluting and dispensing device. Official classification: Class 1. A microtiter diluting and dispensing device is a mechanical device intended for medical purposes to dispense or serially dilute very small quantities of biological or chemical reagents for use in various diagnostic procedures.

Official code: C.2560. Product type: Microbial growth monitor. Official classification: Class 1. A microbial growth monitor is a device intended for medical purposes that measures the concentration of bacteria suspended ina liquid medium by measuring changes in light scattering properties, optical density, electrical impedance, or by making direct bacterial counts. The device aids in the diagnosis of disease caused by pathogenic microorganisms.

Official code: C.2580. Product type: Gas-generating device. Official classification: Class 1. A gas-generating device is a device intended for medical purposes that produces predetermined amounts of selected gases to be used in a closed chamber in order to establish suitable atmospheric conditions for cultivation of microorganisms with special atmospheric requirements. The device aids in the diagnosis of disease.

Official code: C.2600. Product type: Wood's fluorescent lamp. Official classification: Class 1. A Wood's fluorescent lamp is a device intended for medical purposes to detect fluorescent materials (e.g.,fluorescein pigment produced by certain microorganisms) as an aid in the identification of these microorganisms. The device aids in the diagnosis of disease.

Official code: C.2660. Product type: Microorganism differentiation and identification device. Official classification: Class 1. A microorganism differentiation and identification device is a device intended for medical purposes that consists of one or more components, such as differential culturemedia, biochemical reagents, and paper discs or paper strips impregnated with test reagents, that are usually contained in individual compartments and used to differentiate and identify selected microorganisms. The device aids in the diagnosis of disease.

Official code: C.2850. Product type: Automated zone reader. Official classification: Class 1. An automated zone reader is a mechanical device intended for medical purposes to measure zone diameters of microbial growth inhibition (or exhibition), such as those observed on the surface of certain culture media used in disc-agar diffusion antimicrobial susceptibility tests. The device aids in decision making respecting the treatment of disease.

Official code: C.2900. Product type: Microbiological specimen collection and transport device. Official classification: Class 1. A microbiological specimen collection and transport device isa specimen collecting chamber intended for medical purposes to preserve the viability or integrity of microorganisms in specimens during storage of specimens after their collection and during their transport from the collecting area to the laboratory. Thedevice may be labeled or otherwise represented as sterile. The device aids in the diagnosis of disease caused by pathogenic microorganisms.

Official code: C.3010. Product type: Acinetobacter calcoaceticus serological reagents. Official classification: Class 1. Acinetobacter calcoaceticus serological reagents are devices that consist ofAcinetobacter calcoaceticus antigens and antisera used to identify this bacterium from cultured isolates derived from clinical specimens. The identification aids in the diagnosis of disease caused by the bacterium Acinetobacter calcoaceticus and provides epidemiological information on disease caused by this microorganism. This organism becomes pathogenic in patients with burns or with immunologic deficiency, and infection can result in sepsis (blood poisoning).

Official code: C.3020. Product type: Adenovirus serological reagents. Official classification: Class 1. Adenovirus serological reagents are devices that consist of antigens and antisera used in serological tests to identify antibodies to adenovirus in serum. Additionally, some of these reagents consist of adenovirus antisera conjugated witha fluorescent dye and are used to identify adenoviruses directly from clinical specimens. The identification aids in the diagnosis of disease caused by adenoviruses and provides epidemiological information on these diseases. Adenovirus infections may causepharyngitis (inflammation of the throat), acute respiratory diseases, and certain external diseases of the eye (e.g., conjunctivitis).

Official code: C.3035. Product type: Arizona spp. serological reagents. Official classification: Class 1. Arizona spp. serological reagents are devices that consist of antisera and antigens used to identifyArizona spp. in cultured isolates derived from clinical specimens. The identification aids in the diagnosis of disease caused by bacteria belonging to the genus Arizona and provides epidemiological information on diseases caused by these microorganisms.Arizona spp. can cause gastroenteritis (food poisoning) and sepsis (blood poisoning).

Official code: C.3040. Product type: Aspergillus spp. serological reagents. Official classification: Class 1. Aspergillus spp. serological reagents are devices that consist of antigens and antisera used in various serological tests to identify antibodies toAspergillus spp. in serum. The identification aids in the diagnosis of aspergillosis caused by fungi belonging to the genus Aspergillus. Aspergillosis is a disease marked by inflammatory granulomatous (tumor-like) lesions in the skin, ear, eyeball cavity, nasal sinuses, lungs, and occasionally the bones.

Official code: C.3045. Product type: In vitro diagnostic device for Bacillus spp. Detection. Official classification: Class 2. An in vitro diagnostic device for Bacillus species (spp.) detection is a device used to detect and differentiate among Bacillus spp. and presumptively identify B. anthracis and other Bacillus spp. from cultured isolates or clinical specimens as an aid in the diagnosis of anthrax and other diseases caused by Bacillus spp. This device may consist of Bacillus spp. antisera conjugated with a fluorescent dye (immunofluorescent reagents) used to presumptively identify bacillus-like organisms in clinical specimens; bacteriophage used for differentiating B. anthracis from other Bacillus spp. based on susceptibility to lysis by the phage; or antigens used to identify antibodies to B. anthracis (anti-toxin and anti-capsular) in serum. Bacillus infections include anthrax (cutaneous, inhalational, or gastrointestinal) caused by B. anthracis, and gastrointestinal disease and non-gastrointestinal infections caused by B. cereus.

Official code: C.3050. Product type: Beta-glucan serological assays. Official classification: Class 2. Beta-glucan serological assays are devices that consist of antigens or proteases used in serological assays. The device is intended for use for the presumptive diagnosis of fungal infection. The assay is indicated for use in patients with symptoms of, or medical conditions predisposing the patient to invasive fungal infection. The device can be used as an aid in the diagnosis of deep-seated mycoses and fungemia.

Official code: C.3060. Product type: Blastomyces dermatitidis serological reagents. Official classification: Class 1. Blastomyces dermatitidis serological reagents are devices that consist of antigens and antisera used in serological tests toidentify antibodies to Blastomyces dermatitidis in serum. The identification aids in the diagnosis of blastomycosis caused by the fungus Blastomyces dermatitidis. Blastomycosis is a chronic granulomatous (tumor-like) disease, which may be limited to the skin or lung or may be widely disseminated in the body resulting in lesions of the bones, liver, spleen, and kidneys.

Official code: C.3065. Product type: Bordetella spp. serological reagents. Official classification: Class 1. Bordetella spp. serological reagents are devices that consist of antigens and antisera, including antisera conjugated with a fluorescent dye, used in serological tests to identifyBordetella spp. from cultured isolates or directly from clinical specimens. The identification aids in the diagnosis of diseases caused by bacteria belonging to the genusBordetella and provides epidemiological information on these diseases.Bordetella spp. cause whooping cough (Bordetella pertussis) and other similarly contagious and acute respiratory infections characterized by pneumonitis (inflammation of the lungs).

Official code: C.3085. Product type: Brucella spp. serological reagents. Official classification: Class 1. Brucella spp. serological reagents are devices that consist of antigens and antisera used for serological identification ofBrucella spp. from cultured isolates derived from clinical specimens or to identify antibodies toBrucella spp. in serum. Additionally, some of these reagents consist of antisera conjugated with a fluorescent dye (immunofluorescent reagents) used to identifyBrucella spp. directly from clinical specimens or cultured isolates derived from clinical specimens. The identification aids in the diagnosis of brucellosis (e.g., undulant fever, Malta fever) caused by bacteria belonging to the genusBrucella and provides epidemiological information on diseases caused by these microorganisms.

Official code: C.3110. Product type: Campylobacter fetus serological reagents. Official classification: Class 1. Campylobacter fetus serological reagents are devices that consist of antisera conjugated with a fluorescent dye used to identify Campylobacter fetus from clinical specimens or cultured isolates derived from clinical specimens. The identification aids inthe diagnosis of diseases caused by this bacterium and provides epidemiological information on these diseases.Campylobacter fetus is a frequent cause of abortion in sheep and cattle and is sometimes responsible for endocarditis (inflammation of certain membranes of the heart) and enteritis (inflammation of the intestines) in humans.

Official code: C.3120. Product type: Chlamydia serological reagents. Official classification: Class 1. Chlamydia serological reagents are devices that consist of antigens and antisera used in serological tests to identify antibodies to chlamydia in serum. Additionally, some of these reagents consist of chlamydia antisera conjugated with a fluorescent dye used to identify chlamydia directly from clinical specimens or cultured isolates derived from clinical specimens. The identificationaids in the diagnosis of disease caused by bacteria belonging to the genusChlamydia and provides epidemiological information on these diseases. Chlamydia are the causative agents of psittacosis (a form of pneumonia), lymphogranuloma venereum (a venereal disease), and trachoma (a chronic disease of the eye and eyelid).

Official code: C.3125. Product type: Citrobacter spp. serological. Official classification: Class 1. Citrobacter spp. serological reagents are devices that consist of antigens and antisera used in serological tests to identifyCitrobacter reagentsspp. from cultured isolates derived from clinical specimens. The identification aids in the diagnosis of disease caused by bacteria belonging to the genus Citrobacter and provides epidemiological information on diseases caused by these microorganisms. Citrobacter spp. have occasionally been associated with urinary tract infections.

Official code: C.3130. Product type: Clostridium difficile toxin gene amplification assay. Official classification: Class 2. A Clostridium difficile toxin gene amplification assay is a device that consists of reagents for the amplification and detection of target sequencesin Clostridium difficile toxin genes in fecal specimens from patients suspected of having Clostridium difficile infection (CDI). The detection of clostridial toxin genes, in conjunction with other laboratory tests, aids in the clinical laboratory diagnosis of CDI caused by Clostridium difficile.

Official code: C.3135. Product type: Coccidioides immitis serological reagents. Official classification: Class 1. Coccidioides immitis serological reagents are devices that consist of antigens and antisera used in serological tests to identify antibodies to Coccidioides immitis in serum. The identification aids in the diagnosis of coccidioidomycosis caused by a fungus belonging to the genusCoccidioides and provides epidemiological information on diseases caused by this microorganism. An infection with Coccidioides immitis produces symptoms varying in severity from those accompanying the common cold to those of influenza.

Official code: C.3140. Product type: Corynebacterium spp. serological reagents. Official classification: Class 1. Corynebacterium spp. serological reagents are devices that consist of antisera conjugated with a fluorescent dye used to identify Corynebacterium spp. from clinical specimens. The identification aids in the diagnosis of disease caused by bacteria belonging to the genus Corynebacterium and provides epidemiological information on diseases caused by these microorganisms. The principal human pathogen of this genusCorynebacterium diphtheriae, causes diphtheria. However, many other types of corynebacteria form part of the normal flora of the human respiratory tract, other mucus membranes, and skin, and are either nonpathogenic or have an uncertain role.

Official code: C.3145. Product type: Coxsackievirus serological reagents. Official classification: Class 1. Coxsackievirus serological reagents are devices that consist of antigens and antisera used in serological tests to identify antibodies to coxsackievirus in serum. Additionally, some of these reagents consist of coxsackievirus antisera conjugated with a fluorescent dye that are used to identify coxsackievirus from clinical specimens or from tissue culture isolates derived from clinical specimens. The identification aids in the diagnosis of coxsackievirus infections and provides epidemiological information on diseases caused by these viruses. Coxsackieviruses produce a variety of infections, including common colds, meningitis (inflammation of brain and spinal cord membranes),herpangina (brief fever accompanied by ulcerated lesions of the throat), and myopericarditis (inflammation of heart tissue).

Official code: C.3165. Product type: Cryptococcus neoformans serological reagents. Official classification: Class 1. Cryptococcus neoformans serological reagents are devices that consist of antigens used in serological tests to identify antibodies toCryptococcus neoformans in serum. Additionally, some of these reagents consist of antisera conjugated with a fluorescent dye (immunofluorescent reagents) and are used to identify Cryptococcus neoformans directly from clinical specimens or from cultured isolates derived from clinical specimens. The identification aids in the diagnosis of cryptococcosis and provides epidemiological information on this type of disease. Cryptococcosis infections are found most often as chronic meningitis (inflammation of brain membranes) and, if not treated, are usually fatal.

Official code: C.3175. Product type: Cytomegalovirus serological reagents. Official classification: Class 2. Cytomegalovirus serological reagents are devices that consist of antigens and antisera used in serological tests to identify antibodies to cytomegalovirus in serum. The identification aids in the diagnosis of diseases caused by cytomegaloviruses (principally cytomegalic inclusion disease) and provides epidemiological information on these diseases. Cytomegalic inclusion disease is a generalized infection of infants and is caused by intrauterine or early postnatal infection with the virus. Thedisease may cause severe congenital abnormalities, such as microcephaly (abnormal smallness of the head), motor disability, and mental retardation. Cytomegalovirus infection has also been associated with acquired hemolytic anemia, acute and chronic hepatitis,and an infectious mononucleosis-like syndrome.

Official code: C.3200. Product type: Echinococcus spp. serological reagents. Official classification: Class 1. Echinococcus spp. serological reagents are devices that consist ofEchinococcus spp. antigens and antisera used in serological tests to identify antibodies toEchinococcus spp. in serum. The identification aids in the diagnosis of echinococcosis, caused by parasitic tapeworms belonging to the genusEchinococcus and provides epidemiological information on this disease. Echinococcosis is characterized by the development of cysts in the liver, lung, kidneys, and other organs formed by the larva of the infecting organisms.

Official code: C.3205. Product type: Echovirus serological reagents. Official classification: Class 1. Echovirus serological reagents are devices that consist of antigens and antisera used in serological tests to identify antibodies to echovirus in serum. Additionally, some of these reagents consist of echovirus antisera conjugated with a fluorescent dye used to identify echoviruses from clinical specimens or from tissue culture isolates derived from clinical specimens. The identification aids in the diagnosis of echovirus infections and provides epidemiological information on diseases caused by these viruses. Echoviruses cause illnesses such as meningitis (inflammation of the brain and spinal cord membranes), febrile illnesses (accompanied by fever) with or without rash, and the common cold.

Official code: C.3210. Product type: Endotoxin assay. Official classification: Class 2. An endotoxin assay is a device that uses serological techniques in whole blood. The device is intended for use in conjunctionwith other laboratory findings and clinical assessment of the patient to aid in the risk assessment of critically ill patients forprogression to severe sepsis.

Official code: C.3215. Product type: Device to detect and measure non-microbial analyte(s) for patients with suspected sepsis. Official classification: Class 2. A device to detect and measure non-microbial analyte(s) in human clinical specimens to aid in assessment of patients with suspected sepsis is identified as an in vitro device intended for the detection and qualitative and/or quantitative measurement of one or more non-microbial analytes in human clinical specimens to aid in the assessment of patients with suspected sepsis when used in conjunction with clinical signs and symptoms and other clinical and laboratory findings.

Official code: C.3220. Product type: Entamoeba histolytica serological reagents. Official classification: Class 1. Entamoeba histolytica serological reagents are devices that consist of antigens and antisera used in serological tests to identify antibodies toEntamoeba histolytica in serum. Additionally, some of these reagents consist of antisera conjugated with a fluorescent dye (immunofluorescent reagents) used to identify Entamoeba histolytica directly from clinical specimens. The identification aids in the diagnosis of amebiasis caused by the microscopic protozoan parasiteEntamoeba histolytica and provides epidemiological information on diseases caused by this parasite. The parasite may invade the skin, liver, intestines,lungs, and diaphragm, causing disease conditions such as indolent ulcers, an amebic hepatitis, amebic dysentery, and pulmonary lesions.

Official code: C.3225. Product type: Enterovirus nucleic acid assay. Official classification: Class 2. An enterovirus nucleic acid assay is a device that consists of primers, probes, enzymes, and controls for the amplification and detection of enterovirus ribonucleic acid (RNA) in cerebrospinal fluid (CSF) from individuals who have signs and symptoms consistent with meningitis or meningoencephalitis. The detection of enterovirus RNA,in conjunction with other laboratory tests, aids in the clinical laboratory diagnosis of viral meningitis caused by enterovirus.

Official code: C.3235. Product type: Epstein-Barr virus serological reagents. Official classification: Class 1,2. Epstein-Barr virus serological reagents are devices that consist of antigens and antisera used in serological tests to identify antibodies to Epstein-Barr virus in serum. The identification aids in the diagnosis of Epstein-Barr virus infections and provides epidemiological information on diseases caused by these viruses. Epstein-Barr viruses are thought to cause infectious mononucleosis and have been associated with Burkitt's lymphoma (a tumor of the jaw in African children and young adults) and postnasal carcinoma (cancer). Classification: (1) Class1 devices for diagnosis of infectious mononucleosis (2)Class 2 devices for diagnosis, prognosis and treatment of Burkitt's lymphoma, postnasal carcinoma, and other cancer.

Official code: C.3240. Product type: Equine encephalomyelitis virus serological reagents. Official classification: Class 1. Equine encephalomyelitis virus serological reagentsare devices that consist of antigens and antisera used in serological tests to identify antibodies to equine encephalomyelitis virus in serum. The identification aids in the diagnosis of diseases caused by equine encephalomyelitis viruses and provides epidemiological information on these viruses. Equine encephalomyelitis viruses are transmitted to humans by the bite of insects, such as mosquitos and ticks, and may cause encephalitis (inflammation of the brain), rash, acute arthritis, or hepatitis.

Official code: C.3250. Product type: Erysipelothrix rhusiopathiae serological reagents. Official classification: Class 1. Erysipelothrix rhusiopathiae serological reagents are devices that consist of antigens and antisera used in serological teststo identify Erysipelothrix rhusiopathiae from cultured isolates derived from clinical specimens. The identification aids in the diagnosis of disease caused by this bacterium belonging to the genusErysipelothrix. This organism is responsible for a variety of inflammations of the skin following skin abrasions from contact with fish, shellfish, or poultry.

Official code: C.3255. Product type: Escherichia coli serological reagents. Official classification: Class 1. Escherichia coli serological reagents are devices that consist of antigens and antisera used in serological tests to identify Escherichia coli from cultured isolates derived from clinical specimens. Additionally, some of these reagents consist ofEscherichia coli antisera conjugated with a fluorescent dye used to identifyEscherichia coli directly from clinical specimens or cultured isolates derived from clinical specimens. The identification aids in the diagnosis of diseases caused by this bacterium belonging to the genus Escherichia, and provides epidemiological information on diseases caused by this microorganism. AlthoughEscherichia coli constitutes the greater part of the microorganisms found in the intestinal tract in humans and is usually nonpathogenic, those strains which are pathogenic may cause urinary tract infections or epidemic diarrheal disease, especially in children.

Official code: C.3270. Product type: Flavobacterium spp. serological reagents. Official classification: Class 1. Flavobacterium spp. serological reagents are devices that consist of antigens and antisera used in serological tests to identify Flavobacteriuim spp. from cultured isolates derived from clinical specimens. The identification aids in the diagnosis of disease caused by bacteria belonging to the genusFlavobacterium and provides epidemiological information on diseases caused by these microorganisms. Most members of this genus are found in soil and water and, under certain conditions, may become pathogenic to humans.Flavobacterium meningosepticum is highly virulent for the newborn, in whom it may cause epidemics of septicemia (blood poisoning) and meningitis (inflammation of the membranes of the brain) and is usually attributable to contaminated hospital equipment.

Official code: C.3280. Product type: Francisella tularensis serological reagents. Official classification: Class 1. Francisella tularensis serological reagents are devices that consist of antigens and antisera used in serological tests to identify antibodies to Francisella tularensis in serum or to identify Francisella tularensis in cultured isolates derived from clinical specimens. Additionally, some of these reagents consist of antisera conjugated with a fluorescent dye (immunofluorescent reagents) used to identify Francisella tularensis directly from clinical specimens. The identification aids in the diagnosis of tularemia caused by Francisella tularensis and provides epidemiological information on this disease. Tularemia is a disease principally of rodents, but may be transmitted to humans through handling of infected animals, animal products, or by the bites of fleas and ticks. The disease takes on several forms depending upon the site of infection, such as skin lesions, lymph node enlargements, or pulmonary infection.

Official code: C.3290. Product type: Gonococcal antibody test (GAT). Official classification: Class 3. A gonococcal antibody test (GAT) is an in vitro device that consists of the reagents intended to identify by immunochemical techniques, such as latex agglutination, indirect fluorescent antibody, or radioimmunoassay, antibodies toNeisseria gonorrhoeae in seraof asymptomatic females at low risk of infection. Identification of antibodies with this device may indicate past or present infection of the patient with Neisseria gonorrhoeae.

Official code: C.3300. Product type: Haemophilus spp. serological reagents. Official classification: Class 1. Haemophilus spp. serological reagents are devices that consist of antigens and antisera, including antisera conjugated with a fluorescent dye, that are used in serological tests to identifyHaemophilus spp. directly from clinical specimens or tissue culture isolates derived from clinical specimens. The identification aids in the diagnosis of diseases caused by bacteria belonging to the genusHaemophilus and provides epidemiological information on diseases cause by these microorganisms. Diseases most often caused by Haemophilus spp. include pneumonia, pharyngitis, sinusitis, vaginitis, chancroid venereal disease, and a contagious form of conjunctivitis (inflammation of eyelid membranes).

Official code: C.3305. Product type: Herpes simplex virus serological reagents. Official classification: Class 2,3. Herpes simplex virus serological assays are devices that consist of antigens and antisera used in various serological tests to identify antibodies to herpes simplex virus in serum. Additionally, some of the assays consist of herpes simplex virus antisera conjugated with a fluorescent dye (immunofluorescent assays) used to identify herpes simplex virus directly from clinical specimens or tissue culture isolates derived from clinical specimens. The identification aids in the diagnosis of diseases caused by herpes simplex viruses and provides epidemiological information on these diseases. Herpes simplex viral infections range from common and mild lesions of the skin and mucous membranes to a severe form of encephalitis (inflammation of the brain). Neonatal herpes virus infections range from a mild infection to a severe generalized disease with a fatal outcome. Classification: (1)Class 2 devices for HSV1 and/or HSV2 identification;(2) Class 3 devices for other types of HSV identification.

Official code: C.3309. Product type: Herpes virus nucleic acid- based cutaneous and mucocutaneous lesion panel. Official classification: Class 2. A herpes virus nucleic acid-based cutaneous and mucocutaneous lesion panel is a qualitative in vitro diagnostic device intended for the simultaneous detection and differentiation of different herpes viruses in cutaneous and mucocutaneous lesion samples from symptomatic patients suspected of Herpetic infections. Negative results do not preclude infection and should not be used as the sole basis for treatment or other patient management decisions. The assay is not intended for use in cerebrospinal fluid samples.

Official code: C.3320. Product type: Histoplasma capsulatum serological reagents. Official classification: Class 1. Histoplasma capsulatum serological reagents are devices that consist of antigens and antisera used in serological tests to identify antibodies to Histoplasma capsulatum in serum. Additionally, some of these reagents consist ofHistoplasma capsulatum antisera conjugated with a fluorescent dye (immunofluorescent reagents) used to identifyHistoplasma capsulatum from clinical specimens or cultured isolates derived from clinical specimens. The identification aids in the diagnosis of histoplasmosis caused by this fungus belonging to the genusHistoplasma and provides epidemiological information on the diseases caused by this fungus. Histoplasmosis usually is a mild and often asymptomatic respiratory infection, but in a small number of infected individuals the lesions may spread to practically all tissues and organs.

Official code: C.3328. Product type: Influenza virus antigen detection test system. Official classification: Class 2. An influenza virus antigen detection test system is a device for qualitative (rapid screening) detection of influenza virus infection directly from clinical specimens of patients with respiratory symptoms and signs. The test aids in the diagnosis of influenza infection and provides epidemiological information on influenza. Due to the propensity of the virus to mutate, new strains emerge over time which may potentially affect the performance of these devices. Because influenza is highly contagious and may leadto an acute respiratory tract infection causing severe illness and evendeath, the accuracy of these devices has serious public health implications.

Official code: C.3330. Product type: Influenza virus serological reagents. Official classification: Class 1. Influenza virus serological reagents are devices that consist of antigens and antisera used in serological tests to identify antibodies to influenza in serum. The identification aids in the diagnosis of influenza (flu) and provides epidemiological information on influenza. Influenza is an acute respiratory tract disease, which is often epidemic. This classification does not include devices for qualitative (rapid screening) detection of influenza virus infection directly from clinical specimens of patients with respiratory symptoms and signs.

Official code: C.3332. Product type: Reagents for detection of specific novel influenza A viruses. Official classification: Class 2. Reagents for detectionof specific novel influenza A viruses are devices that are intended for use in a nucleic acid amplification test to directly detect specific virus RNA in human respiratory specimens or viral cultures. Detection of specific virus RNAaids in the diagnosis of influenza caused by specific novel influenza A viruses in patients with clinical risk of infection with these viruses, and also aids in the presumptive laboratory identification of specific novel influenza A viruses to provide epidemiological information on influenza. These reagents include primers, probes, and specific influenza A virus controls.

Official code: C.3336. Product type: John Cunningham Virus serological reagents. Official classification: Class 2. John Cunningham Virus serological reagents are devices that consist of antigens and antisera used in serological assays to identify antibodies to John Cunningham Virus in serum and plasma. The identification aids in the risk stratification for the development of progressive multifocal leukoencephalopathy in multiple sclerosis and Crohn's disease patients undergoing natalizumab therapy. These devices are for adjunctive use, in the context of other clinical risk factors for the development of progressive multifocal leukoencephalopathy.

Official code: C.3340. Product type: Klebsiella spp. serological reagents. Official classification: Class 1. Klebsiella spp. serological reagents are devices that consist of antigens and antisera, including antisera conjugated with a fluorescent dye (immunofluorescent reagents), that are used in serological tests to identifyKlebsiella spp. from cultured isolates derived from clinical specimens. The identification aids in the diagnosis of diseases caused by bacteria belonging to the genus Klebsiella and provides epidemiological information on these diseases. These organisms can cause serious urinary tract and pulmonary infections, particularly in hospitalized patients.

Official code: C.3350. Product type: Leptospira spp. serological reagents. Official classification: Class 1. Leptospira spp. serological reagents are devices that consist of antigens and antisera used in serological tests to identifyantibodies to Leptospira spp. in serum or identify Leptospira spp. from cultured isolates derived from clinical specimens. Additionally, some of these antisera are conjugated with a fluorescent dye (immunofluorescent reagents) and used to identifyLeptospira spp. directly from clinical specimens. The identification aids in the diagnosis of leptospirosis caused by bacteria belonging to the genus Leptospira and provides epidemiological information on this disease. Leptospira infections range from mild fever-producing illnesses to severe liver and kidney involvement producing hemorrhage and dysfunction of these organs.

Official code: C.3355. Product type: Listeria spp. serological reagents. Official classification: Class 1. Listeria spp. serological reagents are devices that consist of antigens and antisera used in serological tests to identifyListeria spp. from cultured isolates derived from clinical specimens. Additionally, some of these reagents consist ofListeria spp. antisera conjugated with a fluorescent dye (immunofluorescent reagents) used to identifyListeria spp. directly from clinical specimens. The identification aids in the diagnosis of listeriosis, a disease caused by bacteria belonging to the genusListeria, and provides epidemiological information on diseases caused by these microorganisms.Listeria monocytogenes, the most common human pathogen of this genus, causes meningitis (inflammation of the brain membranes) and meningoencephalitis (inflammation of the brain and brain membranes) and is often fatal if untreated. A second form of human listeriosis is an intrauterine infection in pregnant women that results in a high mortality rate for infants before or after birth.

Official code: C.3360. Product type: Lymphocytic chorimeningitis virus serological reagents. Official classification: Class 1. Lymphocytic choriomeningitis virus serological reagents are devices that consist of antigens and antisera used in serologicaltests toidentify antibodies to lymphocytic choriomeningitis virus in serum. The identification aids in the diagnosis of lymphocytic choriomeningitis virus infections and provides epidemiological information on diseases caused by these viruses. Lymphocytic choriomeningitis viruses usually cause a mild cerebral meningitis (inflammation of membranes that envelop the brain) and occasionally a mild pneumonia, but in rare instances may produce severe and even fatal illnesses due to complications from cerebral meningitis and pneumonia.

Official code: C.3365. Product type: Multiplex nucleic acid assay for identification of microorganisms and resistance markers from positive blood cultures. Official classification: Class 2. A multiplex nucleic acid assay for identification of microorganisms and resistance markers from positive blood cultures is a qualitative in vitro device intended to simultaneously detect and identify microorganism nucleic acids from blood cultures that test positive by Gram stain or other microbiological stains. The device detects specific nucleic acid sequences formicroorganism identification as well as for antimicrobial resistance. This device aids in the diagnosis of bloodstream infections when usedin conjunction with other clinical and laboratory findings. However, the device does not replace traditional methodsfor culture and susceptibility testing.

Official code: C.3370. Product type: Mycobacterium tuberculosis immunofluorescent reagents. Official classification: Class 1. Mycobacterium tuberculosis immunofluorescent reagents are devices that consist of antisera conjugated with a fluorescent dye used to identify Mycobacterium tuberculosis directly from clinical specimens. The identification aids in the diagnosis of tuberculosis and provides epidemiological information on this disease.Mycobacterium tuberculosis is the common causative organism in human tuberculosis, a chronic infectious disease characterized by formation of tubercles (small rounded nodules) and tissue necrosis (destruction), usually occurring in the lung.

Official code: C.3372. Product type: Nucleic acid-based in vitro diagnostic devices for the detection of Mycobacterium tuberculosis complex in respiratory specimens. Official classification: Class 2. Nucleic acid-based in vitro diagnostic devices for the detection of Mycobacterium tuberculosis complex in respiratory specimens are qualitative nucleic acid-based in vitro diagnostic devices intended to detect Mycobacterium tuberculosis complex nucleic acids extracted from human respiratory specimens. These devices are non-multiplexed and intended to be used as an aid in the diagnosis of pulmonary tuberculosis when used in conjunction with clinical and other laboratory findings. These devices do not include devices intended to detect the presence of organism mutations associated with drug resistance. Respiratory specimens may include sputum (induced or expectorated), bronchial specimens (e.g., bronchoalveolar lavage or bronchial aspirate), or tracheal aspirates.

Official code: C.3373. Product type: Nucleic acid-based in vitro diagnostic devices for the detection of Mycobacterium tuberculosis complex (MTB-complex) and the genetic mutations associated with MTB-complex antibiotic resistance in respiratory specimens. Official classification: Class 2. Nucleic acid-based in vitro diagnostic devices for the detection of Mycobacterium tuberculosis complex (MTB-complex) and the genetic mutations associated with MTB-complex antibiotic resistance in respiratory specimens are qualitative nucleic acid-based devices that detect the presence of MTB-complex-associated nucleic acid sequences in respiratory samples. These devices are intended to aid in the diagnosis of pulmonary tuberculosis and the selection of an initial treatment regimen when used in conjunction with clinical findings and other laboratory results. These devices do not provide confirmation of antibiotic susceptibility since other mechanisms of resistance may exist that may be associated with a lack of clinical response to treatment other than those detected by the device.

Official code: C.3375. Product type: Mycoplasma spp. serological reagents. Official classification: Class 1. Mycoplasma spp. serological reagents are devices that consist of antigens and antisera used in serological tests to identify antibodies to Mycoplasma spp. in serum. Additionally, some of these reagents consist ofMycoplasma spp. antisera conjugated with a fluorescent dye (immunofluorescent reagents) used to identifyMycoplasma spp. directly from clinical specimens. The identification aids in the diagnosis of disease caused by bacteria belonging to the genusMycoplasma and provides epidemiological information on diseases caused by these microorganisms. Mycoplasma spp. are associated with inflammatory conditions of the urinary and respiratory tracts, the genitals, and the mouth. The effects in humans of infection withMycoplasma pneumoniae range from inapparent infection to mild or severe upper respiratory disease, ear infection, and bronchial pneumonia.

Official code: C.3380. Product type: Mumps virus serological reagents. Official classification: Class 1. Mumps virus serological reagentsconsist of antigens and antisera used in serological tests to identify antibodies to mumps virus in serum. Additionally, some of these reagents consist of antisera conjugated with a fluorescent dye (immunofluorescent reagents) used in serological tests toidentify mumps viruses from tissue culture isolates derived from clinical specimens. The identification aids in the diagnosis of mumps and provides epidemiological information on mumps. Mumps is an acute contagious disease, particularly in children, characterized by an enlargement of one or both of the parotid glands (glands situated near the ear), although other organs may also be involved.

Official code: C.3390. Product type: Neisseria spp. Direct serological test reagents. Official classification: Class 2. Neisseria spp. direct serological test reagents are devices that consist of antigens and antisera used in serological tests to identify Neisseria spp. from cultured isolates. Additionally, some of these reagents consist ofNeisseria spp. antisera conjugated with a fluorescent dye (immunofluorescent reagents) which may be used to detect the presence ofNeisseria spp. directly from clinical specimens. The identification aids in the diagnosis of disease caused by bacteria belonging to the genusNeisseria, such as epidemic cerebrospinal meningitis, meningococcal disease, and gonorrhea, and also provides epidemiological information on diseases caused by these microorganisms. The device does not include products for the detection of gonorrhea in humans by indirect methods, such as detection of antibodies or of oxidase produced by gonococcal organisms.

Official code: C.3395. Product type: Norovirus serological reagents. Official classification: Class 2. Norovirus serological reagents are devices that consist of antigens and antisera used in serological tests to detect the presence of norovirus antigens in fecal samples. These devicesaid in the diagnosis of norovirus infection in the setting of an individual patient with symptoms of acute gastroenteritis when the individual patient is epidemiologically linked to other patients with symptoms of acute gastroenteritis and/or aid in the identification of norovirus as the etiology of an outbreak of acute gastroenteritis in the setting of epidemiologically linked patients with symptoms of acute gastroenteritis.

Official code: C.3400. Product type: Parainfluenza virus serological reagents. Official classification: Class 1. Parainfluenza virus serologicalreagents are devices that consist of antigens and antisera used in serological tests to identify antibodies to parainfluenza virus in serum. The identification aids in the diagnosis of parainfluenza virus infections and provides epidemiological information on diseases caused by these viruses. Parainfluenza viruses cause a variety of respiratory illnesses ranging from the common cold to pneumonia.

Official code: C.3402. Product type: Plasmodium species antigen detection assays. Official classification: Class 2. A Plasmodium species antigen detection assay is a devicethat employs antibodies for the detection of specific malaria parasite antigens, including histidine-rich protein-2 (HRP2) specific antigens, and pan malarial antigens in human whole blood. These devices are used for testing specimens from individuals whohave signs and symptoms consistent with malaria infection. The detection of these antigens aids in the clinical laboratory diagnosis of malaria caused by the four malaria species capable of infecting humans: Plasmodium falciparum, Plasmodium vivax, Plasmodium oval, andPlasmodium malariae, and aids in the differential diagnosis of Plasmodium falciparum infections from other less virulentPlasmodium species. The device is intended for use in conjunction with other clinical laboratory findings.

Official code: C.3405. Product type: Poliovirus serological reagents. Official classification: Class 1. Poliovirus serological reagents are devices that consist of antigens and antisera used in serological tests to identify antibodies to poliovirus in serum. Additionally, some of these reagents consist of poliovirus antisera conjugated with a fluorescent dye (immunofluorescent reagents) used to identify polioviruses from clinical specimens or from tissue culture isolates derived from clinical specimens. The identification aids in the diagnosis of poliomyelitis (polio) and providesepidemiological information on this disease. Poliomyelitis is an acute infectious disease which in its serious form affects the central nervous system resulting in atrophy (wasting away) of groups of muscles, ending in contraction and permanent deformity.

Official code: C.3410. Product type: Proteus spp. (Weil-Felix) serological reagents. Official classification: Class 1. Proteus spp. (Weil-Felix) serological reagents are devices that consist of antigens and antisera, including antisera conjugated with a fluorescent dye (immunofluorescent reagents), derived from the bacteriumProteus vulgaris used in agglutination tests (a specific type of antigen-antibody reaction) for the detection of antibodies to rickettsia (virus-like bacteria) in serum. Test results aid in the diagnosis of diseases caused by bacteria belonging to the genusRickettsiae and provide epidemiological information on these diseases. Rickettsia are generally transmitted by arthropods (e.g.,ticks and mosquitoes) and produce infections in humans characterized by rash and fever (e.g., typhus fever, spotted fever, Q fever, and trench fever).

Official code: C.3415. Product type: Pseudomonas spp. serological reagents. Official classification: Class 1. Pseudomonas spp. serological reagents are devices that consist of antigens and antisera, including antisera conjugated with a fluorescent dye (immunofluorescent reagents), used to identifyPseudomonas spp. from clinical specimens or from cultured isolates derived from clinical specimens. The identification aids in the diagnosis of disease caused by bacteria belonging to the genus Pseudomonas. Pseudomonas aeruginosa is a major cause of hospital-acquired infections, and has been associated with urinary tract infections, eye infections, burn and wound infections, blood poisoning, abscesses, and meningitis (inflammation of brain membranes). Pseudomonas pseudomallei causes melioidosis, a chronic pneumonia.

Official code: C.3460. Product type: Rabiesvirus immunofluorescent reagents. Official classification: Class 2. Rabiesvirus immunofluorescent reagents are devices that consist of rabiesvirus antisera conjugated with a fluorescent dye used to identify rabiesvirus in specimens taken from suspected rabid animals. The identification aids in the diagnosis of rabies in patients exposed by animal bites and provides epidemiological information on rabies. Rabies is an acute infectious disease of the central nervous system which, if undiagnosed, may be fatal. The disease is commonly transmitted to humans by a bite from a rabid animal.

Official code: C.3470. Product type: Reovirus serological reagents. Official classification: Class 1. Reovirus serological reagents are devices that consist of antigens and antisera used in serological tests to identify antibodies to reovirus in serum. The identification aids in the diagnosis of reovirus infections and provides epidemiological information on diseases caused by these viruses. Reoviruses are thought to cause only mild respiratory and gastrointestinal illnesses.

Official code: C.3480. Product type: Respiratory syncytial virus serological reagents. Official classification: Class 1. Respiratory syncytial virus serological reagents are devices that consist of antigens and antisera used in serological teststo identify antibodies to respiratory syncytial virus in serum. Additionally, some of these reagents consist of respiratory syncytial virus antisera conjugated with a fluorescent dye (immunofluorescent reagents) and used to identify respiratory syncytial viruses from clinical specimens or from tissue culture isolates derived from clinical specimens. The identification aids in the diagnosis of respiratory syncytial virus infections and provides epidemiological information on diseases caused by these viruses. Respiratory syncytial viruses cause a number of respiratory tract infections, including the common cold, pharyngitis, and infantile bronchopneumonia.

Official code: C.3490. Product type: Rhinovirus serological reagents. Official classification: Class 1. Rhinovirus serological reagents are devices that consist of antigens and antisera used in serological tests to identify antibodies to rhinovirusin serum. The identification aids in the diagnosis of rhinovirus infections and provides epidemiological information on diseases caused by these viruses. Rhinoviruses cause common colds.

Official code: C.3500. Product type: Rickettsia serological reagents. Official classification: Class 1. Rickettsia serological reagents are devices that consist of antigens and antisera used in serological tests to identify antibodies to rickettsia in serum. Additionally, some of these reagents consist of rickettsial antisera conjugated with a fluorescent dye (immunofluorescent reagents) used to identify rickettsia directly from clinical specimens. The identification aids in the diagnosis of diseases caused by virus-like bacteria belonging to the genusRickettsiae and provides epidemiological information on these diseases. Rickettsia are generally transmitted by arthropods (e.g.,ticks and mosquitoes) and produce infections in humans characterized by rash and fever (e.g., typhus fever, spotted fever, Q fever, and trench fever).

Official code: C.3510. Product type: Rubella virus serological reagents. Official classification: Class 2. Rubella virusserological reagents are devices that consist of antigens and antisera used in serological tests to identify antibodies to rubella virus in serum. The identification aids in the diagnosis of rubella (German measles) or confirmation of a person'simmune status from past infections or immunizations and provides epidemiological information on German measles. Newborns infected in the uterus with rubella virus may be born with multiple congenital defects (rubella syndrome).

Official code: C.3520. Product type: Rubeola (measles) virus serological reagents. Official classification: Class 1. Rubeola (measles) virus serological reagents are devices that consist of antigens and antisera used in serological tests to identify antibodies to rubeola virus in serum. The identification aids in the diagnosis of measles and provides epidemiological information on the disease. Measles is an acute, highly infectious disease of the respiratory and reticuloendothelial tissues, particularly in children, characterized by a confluent and blotchy rash.

Official code: C.3550. Product type: Salmonella spp. serological reagents. Official classification: Class 1. Salmonella spp. serological reagents are devices that consist of antigens and antisera used in serological tests to identifySalmonella spp. from cultured isolates derived from clinical specimens. The identification aids in the diagnosis of salmonellosis caused by bacteria belonging to the genusSalmonella and provides epidemiological information on this disease. Salmonellosis is characterized by high grade fever ("enteric fever"), severe diarrhea, and cramps.

Official code: C.3600. Product type: Schistosoma spp. serological reagents. Official classification: Class 1. Schistosoma spp. serological reagents are devices that consist of antigens and antisera used in serological tests to identify antibodies to Schistosoma spp. in serum. The identification aids in the diagnosis of schistosomiasis caused by parasitic flatworms of the genusSchistosoma. Schistosomiasis is characterized by a variety of acute and chronic infections. Acute infection is marked by fever, allergic symptoms, and diarrhea. Chronic effects are usually severe and are caused by fibrous degeneration of tissue around deposited eggs of the parasite in the liver, lungs, and central nervous system. Schistosomes can also cause schistosome dermatitis (e.g., swimmer's itch), a skin disease marked by intense itching.

Official code: C.3630. Product type: Serratia spp. serological reagents. Official classification: Class 1. Serratia spp. serological reagents are devices that consist of antigens and antisera used in serological tests to identifySerratia spp. from cultured isolates. The identification aids in the diagnosis of disease caused by bacteria belonging to the genusSerratia and provides epidemiological information on these diseases.Serratia spp. are occasionally associated with gastroenteritis (food poisoning) and wound infections.

Official code: C.3660. Product type: Shigella spp. serological reagents. Official classification: Class 1. Shigella spp. serological reagents aredevices that consist of antigens and antisera, including antisera conjugated with a fluorescent dye (immunofluorescent reagents), used in serological tests to identifyShigella spp. from cultured isolates. The identification aids in the diagnosis of shigellosis caused by bacteria belonging to the genusShigella and provides epidemiological information on this disease. Shigellosis is characterized by abdominal pain, cramps, diarrhea, and fever.

Official code: C.3680. Product type: Sporothrix schenckii serological reagents. Official classification: Class 1. Sporothrix schenckii serological reagents are devices that consist of antigens and antisera used in serological tests to identify antibodies toSporothrix schenckii in serum. The identification aids in the diagnosis of sporothrichosis caused by a fungus belonging to the genusSporothrix and provides epidemiological information on this disease. Sporothrichosis is a chronic tumorlike infection primarily of the skin.

Official code: C.3700. Product type: Staphylococcus aureus serological reagents. Official classification: Class 1. Staphylococcus aureus serological reagents are devices that consist of antigens and antisera used in serological tests to identify enterotoxin (toxin affecting the intestine) producing staphylococci from cultured isolates. The identification aids in the diagnosis of disease caused by this bacterium belonging to the genusStaphylococcus and provides epidemiological information on these diseases. Certain strains ofStaphylococcus aureus produce an enterotoxin while growing in meat, dairy, or bakery products. After ingestion, this enterotoxin is absorbed in the gut and causes destruction of the intestinal lining (gastroenteritis).

Official code: C.3720. Product type: Streptococcus spp. exoenzyme reagents. Official classification: Class 1. Streptococcus spp. exoenzyme reagents are devices used to identify antibodies toStreptococcus spp. exoenzyme in serum. The identification aids in the diagnosis of disease caused by bacteria belonging to the genusStreptococcus and provides epidemiological information on these diseases. Pathogenic streptococci are associated with infections, such as sore throat, impetigo (an infection characterized by small pustules on the skin), urinary tract infections, rheumatic fever, and kidney disease.

Official code: C.3740. Product type: Streptococcus spp. serological reagents. Official classification: Class 1. Streptococcus spp. serological reagents are devices that consist of antigens and antisera (excluding streptococcal exoenzyme reagents made from enzymes secreted by streptococci) used in serological tests to identifyStreptococcus spp. from cultured isolates derived from clinical specimens. The identification aids in the diagnosis of diseases caused by bacteria belonging to the genus Streptococcus and provides epidemiological information on these diseases. Pathogenic streptococci are associated with infections, such as sore throat, impetigo (an infection characterized by small pustules on the skin), urinarytract infections, rheumatic fever, and kidney disease.

Official code: C.3780. Product type: Toxoplasma gondii serological reagents. Official classification: Class 2. Toxoplasma gondii serological reagents are devices that consist of antigens and antisera used in serological tests to identify antibodies to Toxoplasmagondii in serum. Additionally, some of these reagents consist of antisera conjugated with a fluorescent dye (immunofluorescent reagents) used to identifyToxoplasma gondii from clinical specimens. The identification aids in the diagnosis of toxoplasmosis caused by the parasitic protozoanToxoplasma gondii and provides epidemiological information on this disease. Congenital toxoplasmosis is characterized by lesions of the central nervous system, which if undetected and untreated may lead to brain defects, blindness, and death of an unborn fetus. The disease is characterized in children by inflammation of the brain and spinal cord.

Official code: C.3820. Product type: Treponema pallidum nontreponemal test reagents. Official classification: Class 2. Treponema pallidum nontreponemal test reagents are devices that consist of antigens derived from nontreponemal sources (sources not directly associated with treponemal organisms) and control sera (standardized sera with which test results are compared)used in serological tests to identify reagin, an antibody-like agent, whichis produced from the reaction of treponema microorganisms with body tissues. The identification aids in the diagnosis of syphilis caused by microorganisms belonging to the genusTreponema and provides epidemiological information on syphilis.

Official code: C.3830. Product type: Treponema pallidum treponemal test reagents. Official classification: Class 2. Treponema pallidum treponemal test reagents are devices that consist of the antigens, antisera and all control reagent (standardized reagents with which test results are compared), and is used in Fluorescent treponemal antibody absorption, FTA-ABS, Treponema pallidum immobilization (T.P.I.) and other tests for other treponema to identify the treponemal antigen and antibody in the serum. The identification aids in the diagnosis of syphilis caused by bacteria belonging to the genusTreponema and provides epidemiological information on syphilis.

Official code: C.3850. Product type: Trichinella spiralis serological reagents. Official classification: Class 1. Trichinella spiralis serological reagents are devices that consist of antigens and antisera used in serological tests to identify antibodies toTrichinella spiralis in serum. The identification aids in the diagnosis of trichinosis caused by parasitic roundworms belonging to the genus Trichinella and provides epidemiological information on trichinosis. Trichinosis is caused by ingestion of undercooked, infested meat, especially pork, and characterized by fever, muscle weakness, and diarrhea.

Official code: C.3860. Product type: Trichomonas vaginalis nucleic acid assay. Official classification: Class 2. A Trichomonas vaginalis nucleic acid assay is a device that consists of primers, probes, enzymes, and controls for the amplification and detection of trichomonas nucleic acids in endocervical swabs, vaginal swabs, and female urine specimens, from women symptomatic for vaginitis, cervicitis, or urethritis and/or to aid in the diagnosis of trichomoniasis in asymptomatic women. The detection of trichomonas nucleic acids, in conjunction with other laboratory tests, aids in the clinical laboratory diagnosisof trichomoniasis caused by Trichomonas vaginalis.

Official code: C.3870. Product type: Trypanosoma spp. serological reagents. Official classification: Class 1. Trypanosoma spp. serological reagents are devices that consist of antigens and antisera used in serological tests to identify antibodies to Trypanosoma spp. in serum. The identification aids in the diagnosis of trypanosomiasis, a disease caused by parasitic protozoans belonging to the genusTrypanosoma. Trypanosomiasis in adults is a chronic disease characterized by fever, chills, headache, and vomiting. Central nervous system involvement produces typical sleeping sickness syndrome: physical exhaustion, inability to eat, tissue wasting, and eventual death. Chagas disease, an acute form of trypanosomiasis in children, most seriously affects the central nervous system and heart muscle.

Official code: C.3900. Product type: Varicella-zoster virus serological reagents. Official classification: Class 2. Varicella-zoster virus serological reagents are devices that consist of antigens and antisera used in serological tests to identify antibodies to varicella-zoster in serum. The identification aids in the diagnosis of diseases caused by varicella-zoster viruses and providesepidemiological information on these diseases. Varicella (chicken pox) is a mild, highly infectious disease, chiefly of children. Zoster (shingles) is the recurrent form of the disease, occurring in adults who were previously infected with varicella- zoster viruses. Zoster is the response (characterized by a rash) of the partially immune host to a reactivation of varicella viruses present in latent form in the patient's body.

Official code: C.3930. Product type: Vibrio cholerae serological reagents. Official classification: Class 1. Vibrio cholerae serological reagents are devices that are used in the agglutination (an antigen-antibody clumping reaction) test to identifyVibrio cholerae from cultured isolates derived from clinical specimens. The identification aids in the diagnosis of cholera caused by the bacterium Vibrio cholerae and provides epidemiological information on cholera. Cholera is an acute infectious disease characterized by severe diarrhea with extreme fluid and electrolyte (salts) depletion, and by vomiting, muscle cramps, and prostration. If untreated, the severe dehydration may lead to shock, renal failure, cardiovascular collapse, and death.

Official code: C.3940. Product type: West Nile virus serological reagents. Official classification: Class 2. West Nile virus serological reagents are devices that consist of antigens and antisera for the detection of anti-WestNile virus IgM antibodies, in human serum, from individuals who have signs and symptoms consistent with viral meningitis/encephalitis. The detection aids in the clinical laboratory diagnosis of viral meningitis/encephalitis caused by West Nile virus.

Official code: C.3946. Product type: Dengue virus nucleic acid. Official classification: Class 2. Dengue virus nucleic acid amplification test reagents are devices that consist of primers, probes, enzymes, and controls forthe amplification test reagentsamplification and detection of dengue virus serotypes 1, 2, 3, or 4from viral ribonucleic acid (RNA) in human serum and plasma from individuals who have signs and symptoms consistent with dengue (mild or severe). This testprovides epidemiologic information for surveillance of circulating dengue viruses.

Official code: C.3950. Product type: In vitro human immunodeficiency virus (HIV) drug resistance genotype assay. Official classification: Class 2. The in vitro HIV drug resistance genotype assay is a device that consists of nucleic acid reagent primers and probes togetherwith software for predicting drug resistance/susceptibility based on results obtained with these primers and probes. It is intended for use in detecting HIV genomic mutations that confer resistance to specific antiretroviral drugs, as an aid in monitoring and treating HIV infection.

Official code: C.3955. Product type: Human immunodeficiency virus (HIV) drug resistance genotyping assay using next generation sequencing technology. Official classification: Class 2. The HIV drug resistance genotyping assay using next generation sequencing (NGS) technology is an in vitro diagnostic device intended for use in detecting HIV genomic mutations that confer resistance to specific antiretroviral drugs. The device is intended to be used as an aid in monitoring and treating HIV infection.

Official code: C.3970. Product type: Device to detect and identify microbial pathogen nucleic acids in cerebrospinal fluid. Official classification: Class 2. A deviceto detect and identify microbial pathogen nucleic acids in cerebrospinal fluid is a qualitative in vitro device intended for the detection and identification of microbial-associated nucleic acid sequences from patients suspected of meningitis or encephalitis. A device to detect and identify microbial pathogen nucleic acids in cerebrospinal fluid is intended to aid in the diagnosis of meningitis or encephalitis when used in conjunction with clinical signs and symptoms and other clinical and laboratory findings.

Official code: C.3980. Product type: Respiratory viral panel multiplex nucleic acid assay. Official classification: Class 2. A respiratory viral panel multiplex nucleic acid assay is a qualitative in vitro diagnostic device intended to simultaneouslydetect and identify multiple viral nucleic acids extracted from human respiratory specimens or viral culture. The detection and identification of a specific viral nucleic acid from individuals exhibiting signs and symptoms of respiratory infection aidsin the diagnosis of respiratory viral infection when used in conjunction with other clinical and laboratory findings. The device is intended for detection and identification of a combination of the following viruses:(1) Influenza A and Influenza B;(2) Influenza A subtype H1 and Influenza A subtype H3;(3)Respiratory Syncytial Virus subtype A and Respiratory Syncytial Virus subtype B;(4) Parainfluenza 1, Parainfluenza 2, and Parainfluenza 3 virus;(5) Human Metapneumovirus;(6) Rhinovirus; and(7) Adenovirus.

Official code: C.3985. Product type: Device to detect and identify microorganisms and associated resistance marker nucleic acids directly in respiratory specimens. Official classification: Class 2. A device to detect and identify microorganisms and associated resistance marker nucleic acids directly from respiratory specimens is an in vitro diagnostic device intended for the detection and identification of microorganisms and associated resistance markers in respiratory specimens collected from patients with signs or symptoms of respiratory infection. The device is intended to aid in the diagnosis of respiratory infection in conjunction with clinical signs and symptoms and other laboratory findings. These devices do not provide confirmation of antibiotic susceptibility since mechanisms of resistance may exist other than those detected by the device.

Official code: C.3990. Product type: Gastrointestinal. Official classification: Class 2. A gastrointestinal microorganism multiplex nucleic acid-based assay is a qualitative in vitro diagnostic device intended to microorganism multiplex nucleic acid-based assay simultaneously detect and identify multiple gastrointestinal microbial nucleic acids extracted from human stool specimens. The device detects specific nucleic acid sequences for organism identification as well as for determining the presence of toxin genes. The detection and identification of a specific gastrointestinal microbial nucleic acid from individuals exhibiting signs and symptoms of gastrointestinal infection aids in the diagnosis of gastrointestinal infection when used in conjunction with clinical evaluation and other laboratory findings. A gastrointestinal microorganism multiplex nucleic acid-based assay also aids in the detection and identification of acute gastroenteritis in the context of outbreaks.

Official code: C.4070. Product type: RNA Preanalytical Systems. Official classification: Class 1,2. RNA Preanalytical Systems are devices intended to collect, store, and transport patient specimens, and stabilize intracellular RNA from the specimens, for subsequent isolation and purification of the intracellular RNA for RT-PCR used in in vitro molecular diagnostic testing. Classification: (1) Class 1: Automatic specimen processing equipment. (2) Class 2: Reagents for isolation and purification.

Official code: C.4100. Product type: Complement reagent. Official classification: Class 1. A complement reagent is a device that consists of complement, a naturally occurring serum protein from any warm-blooded animal such as guinea pigs, that may be included as a component part of serological test kits used in the diagnosis of disease.

Official code: C.4500. Product type: Immunoelectrophoresis equipment. Official classification: Class 1. Immunoelectrophoresis equipment for clinical use with its electrical power supply is a device used for separating protein molecules. Immunoelectrophoresis is a procedure in which a complex protein mixture is placed in an agar gel and the various proteins are separated on the basis of their relative mobilities under the influence of an electric current. The separated proteins are then permittedto diffuse through the agar toward a multispecific antiserum, allowing precipitation and visualization of the separate complexes.

Official code: C.4520. Product type: Immunofluorometer equipment. Official classification: Class 1. Immunofluorometer equipment for clinical use with its electrical power supply is a device used to measure the fluorescence of fluorochrome-labeled antigen-antibody complexes. The concentration of these complexes may be measured by means of reflected light. A beam of light is passed through a solution in which a fluorochrome has been selectively attached to serum protein antibody molecules in suspension. The amount of light emitted by the fluorochrome label is detected by a photodetector, which converts light energy into electrical energy. The amount of electrical energy registers on a readoutsystem such as a digital voltmeter or a recording chart. This electrical readout is called the fluorescence value and is used to measure the concentration of antigen-antibody complexes.

Official code: C.4540. Product type: Immunonephelometer equipment. Official classification: Class 1. Immunonephelometer equipment for clinical use with its electrical power supply is a device that measures light scattering from antigen-antibody complexes. The concentration of these complexes may be measured by means of reflected light. A beam of light passed through a solution is scattered by the particles in suspension. The amount of light is detected by a photodetector, which converts light energy into electrical energy. The amount of electrical energy registers on a readout system such as a digitalvoltmeter or a recording chart. This electrical readout is called the light-scattering value and is used to measure the concentration of antigen- antibody complexes. This generic type of device includes devices with various kinds of light sources, such as laser equipment.

Official code: C.4600. Product type: Ouchterlony agar plate. Official classification: Class 1. An ouchterlony agar plate for clinical use is a device containing an agar gel used to examine antigen-antibody reactions. In immunodiffusion, antibodies and antigens migrate toward each other through gel which originally contained neither ofthese reagents. As the reagents come in contact with each other, they combine to form a precipitate that is trapped in the gel matrix and is immobilized.

Official code: C.4700. Product type: Automated fluorescence in situ hybridization (FISH) enumeration systems. Official classification: Class 2. An automated FISH enumeration system is a device that consists of an automated scanning microscope, image analysis system, and customized software applications for FISH assays. This device is intended for in vitro diagnostic use with FISH assays asan aid in the detection, counting and classification of cells based on recognition of cellular color, size, and shape, and in the detection and enumeration of FISH signals in interphase nuclei of formalin-fixed, paraffin-embedded human tissue specimens.

Official code: C.4750. Product type: Automated indirect immunofluorescence microscope and software- assisted system. Official classification: Class 2. An automated indirect immunofluorescence microscope and software-assisted system is a device that acquires, analyzes, stores, and displays digital images of indirect immunofluorescent slides. It is intended to be used as an aid in the determination of antibody status in clinical samples. The device may include a fluorescence microscope with light source, a motorized microscope stage, dedicated instrument controls, a camera, a computer, a sample processor, or other hardware components. The software may include fluorescent signal acquisition and processing software, data storage and transferring mechanisms, or assay specific algorithms to suggest results. A trained operator must confirm results generated with the device.

Official code: C.4800. Product type: Radial immunodiffusion plate. Official classification: Class 1. A radial immunodiffusion plate for clinical use is a device that consists of a plastic plate to which agar gel containing antiserum is added. In radial immunodiffusion, antigens migrate through gel which originally contains specific antibodies. As the reagents come in contact with each other, they combine to form a precipitate that is trapped in the gel matrix and immobilized.

Official code: C.4830. Product type: Rocket immunoelectrophoresis equipment. Official classification: Class 1. Rocket immunoelectrophoresis equipment for clinical use is a device used to perform a specific test on proteins by using a procedure called rocket immunoelectrophoresis. In this procedure, an electric current causes the protein in solution to migrate through agar gel containing specific antisera. The protein precipitates with the antisera in a rocket-shaped pattern, giving the name to the device. The height of the peak (or the area under the peak) is proportional to the concentration of the protein.

Official code: C.5040. Product type: Albumin immunological test system. Official classification: Class 1. An albumin immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the albumin (a plasma protein) in serum and other body fluids. Measurement of albumin aids in the diagnosis of kidneyand intestinal diseases.

Official code: C.5060. Product type: Prealbumin immunological test system. Official classification: Class 1. A prealbumin immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the prealbumin (a plasma protein) in serum and other bodyfluids. Measurement of prealbumin levels in serum may aid in the assessment of the patient's nutritional status.

Official code: C.5065. Product type: Human allotypic marker immunological test system. Official classification: Class 1. A human allotypic marker immunological test system is a device that consists of thereagents used to identify by immunochemical techniques the inherited human protein allotypic markers (such as nGm, nA2m, and Km allotypes) in serum and other body fluids. The identification may be used while studying population genetics.

Official code: C.5080. Product type: Alpha-1-antichymotrypsin immunological test system. Official classification: Class 2. A alpha-1-antichymotrypsin immunological test system is a device that consists of the reagents used to measure by immunochemical techniquesalpha-1-antichymotrypsin (a protein) in serum, other body fluids, and tissues. Alpha-1- antichymotrypsin helps protect tissues against proteolytic (protein-splitting) enzymes released during infection.

Official code: C.5090. Product type: Antimitochondrial antibody immunological test system. Official classification: Class 2. An antimitochondrial antibody immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the antimitochondrial antibodies in human serum. The measurements aid in the diagnosis of diseases that produce a spectrum of autoantibodies (antibodies produced against the body's own tissue), such as primary biliary cirrhosis (degeneration of liver tissue) and chronic active hepatitis (inflammation of the liver).

Official code: C.5100. Product type: Antinuclear antibody immunological test system. Official classification: Class 2. An antinuclear antibody immunological test system is a devicethat consists of the reagents used to measure by immunochemical techniques the autoimmune antibodies in serum, other body fluids, and tissues that react with cellular nuclear constituents (molecules present in the nucleus of a cell, such as ribonucleic acid, deoxyribonucleic acid, or nuclear proteins). The measurements aid in the diagnosis of systemic lupus erythematosus (a multisystem autoimmune disease in which antibodies attack the victim's own tissues), hepatitis (a liver disease), rheumatoid arthritis, Sjogren's syndrome (arthritis with inflammation of the eye, eyelid, and salivary glands), and systemic sclerosis (chronic hardening and shrinking of many body tissues).

Official code: C.5110. Product type: Antiparietal antibody immunological test system. Official classification: Class 2. An antiparietal antibody immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the specific antibody for gastric parietal cells in serum and other body fluids. Gastric parietal cells are thosecells located in the stomach that produce a protein that enables vitamin B12to be absorbed by the body. The measurements aid in the diagnosis of vitamin B12deficiency (or pernicious anemia), atrophic gastritis (inflammation of the stomach), and autoimmune connective tissue diseases (diseases resulting when the body produces antibodies against its own tissues).

Official code: C.5120. Product type: Antismooth muscle antibody immunological test system. Official classification: Class 2. An antismooth muscle antibody immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the antismooth muscle antibodies (antibodies to nonstriated, involuntary muscle) in serum. The measurements aid in the diagnosis of chronic hepatitis (inflammation of the liver) and autoimmune connective tissue diseases (diseases resulting from antibodies produced against the body's own tissues).

Official code: C.5130. Product type: Alpha-1-antitrypsin immunological test system. Official classification: Class 2. A alpha-1-antitrypsin immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the alpha-1-antitrypsin (a plasma protein) in serum, other body fluids, and tissues. The measurements aid in the diagnosis of several conditions including juvenile and adult cirrhosis of the liver. In addition, alpha-1-antitrypsin deficiency has been associated with pulmonary emphysema.

Official code: C.5150. Product type: Bence-Jones proteins immunological test system. Official classification: Class 2. A Bence-Jones proteins immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the Bence-Jones proteins inurine and plasma. Immunoglobulin molecules normally consist of pairs of polypeptide chains (subunits) of unequal size (light chains and heavy chains) bound together by several disulfide bridges. In some cancerous conditions, there is a proliferation of one plasma cell (antibody-producing cell) with excess production of light chains of one specific kind (monoclonal light chains). These free homogeneous light chains not associated with an immunoglobulin molecule can be found in urine and plasma, and have been called Bence-Jones proteins. Measurement of Bence-Jones proteins and determination that they are monoclonal aid in the diagnosis of multiple myeloma (malignant proliferation of plasma cells), Waldenstrom's macroglobulinemia (increased production of largeimmunoglobulins by spleen and bone marrow cells), leukemia (cancer of the blood-forming organs), and lymphoma (cancer of the lymphoid tissue).

Official code: C.5160. Product type: Beta-globulin immunological test system. Official classification: Class 1. A beta-globulin immunological test system is a device that consists of reagents used to measure by immunochemical techniques beta globulins (serum protein) in serum and other body fluids. Beta -globulin proteins include beta -lipoprotein, transferrin, glycoproteins, and complement, and are rarely associated with specific pathologic disorders.

Official code: C.5170. Product type: Breast milk immunological test system. Official classification: Class 1. A breast milk immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the breast milk proteins.

Official code: C.5180. Product type: Fecal calprotectin immunological test system. Official classification: Class 2. A fecal calprotectin immunological test system is anin vitro diagnostic device that consists of reagents used to quantitatively measure, by immunochemical techniques, fecal calprotectin in human stool specimens. The device is intended forin vitro diagnostic use as an aid in the diagnosis of inflammatory bowel diseases (IBD), specifically Crohn's disease and ulcerative colitis, and as an aid in differentiation of IBD from irritable bowel syndrome.

Official code: C.5200. Product type: Carbonic anhydrase B and C immunological test system. Official classification: Class 1. A carbonic anhydrase B and C immunological test system is a device that consists of the reagents used to measure by immunochemical techniques specific carbonic anhydrase protein molecules in serum and other body fluids. Measurements of carbonic anhydrase B and C aid in the diagnosis of abnormal hemoglobin metabolism.

Official code: C.5210. Product type: Ceruloplasmin immunological test system. Official classification: Class 2. A ceruloplasmin immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the ceruloplasmin (copper-transporting serum protein) in serum, other body fluids, or tissues. Measurements of ceruloplasmin aid in the diagnosis of copper metabolism disorders.

Official code: C.5220. Product type: Cohn fraction II immunological test system. Official classification: Class 1. A Cohn fraction II immunological test system is a device that consists of the reagents that contain or are used to measure that fraction of plasma containing protein gamma globulins, predominantly of the IgG class. The device may be used as a coprecipitant in radioimmunoassay methods, as raw material for the purification of IgG subclasses, and to reduce nonspecific adsorption of plasma proteins in immunoassay techniques. Measurement of these proteins aids in the diagnosis of any disease concerned with abnormal levels of IgG gamma globulins such as agammaglobulinemia or multiple myeloma.

Official code: C.5230. Product type: Colostrum immunological test system. Official classification: Class 1. A colostrum immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the specificproteins in colostrum. Colostrum is a substance excreted by the mammary glands during pregnancy and until production of breast milk begins 1 to 5 days after childbirth.

Official code: C.5240. Product type: Complement components immunological test system. Official classification: Class 2. A complement components immunological test system is a device that consists of the reagents used to measure by immunochemical techniques complement components C1q, C1r, C1s, C2, C3, C4, C5, C6, C7, C8, and C9, in serum, other body fluids, and tissues. Complement is a group of serum proteins which destroy infectious agents. Measurements of these proteins aids in the diagnosis of immunologic disorders, especially those associated with deficiencies of complement components.

Official code: C.5250. Product type: Complement C1 inhibitor (inactivator) immunological. Official classification: Class 2. A complement C1inhibitor (inactivator) immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the complement C1inhibitor (a plasma protein) in serum. Complement C1inhibitor occurs normally test systemin plasma and blocks the action of the C1component of complement (a group of serum proteins which destroy infectious agents). Measurement of complement C1inhibitor aids in the diagnosis of hereditary angioneurotic edema (increased blood vessel permeability causing swelling of tissues) and a rare form of angioedema associated with lymphoma (lymph node cancer).

Official code: C.5260. Product type: Complement C3b inactivator immunological test system. Official classification: Class 2. A complement C3binactivator immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the complement C3binactivator (a plasma protein) in serum. Complement is a group of serum proteins that destroy infectious agents. Measurement of complement C3binactivator aids in the diagnosis of inherited antibody dysfunction.

Official code: C.5270. Product type: C-reactive protein immunological test system. Official classification: Class 2. A C-reactive protein immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the C-reactive protein in serum and other body fluids. Measurement of C-reactive protein aids in evaluation of the amount of injury to body tissues.

Official code: C.5320. Product type: Properdin factor B immunological test system. Official classification: Class 1. A properdin factor B immunological test system is a device that consists of the reagents used to measure by immunochemical techniques properdin factor B in serum and other body fluids. The deposition of properdin factor B in body tissues or a corresponding depression in the amount of properdin factor B in serum and other body fluids is evidenceof the involvement of the alternative to the classical pathway of activation of complement (a group of plasma proteins which cause the destructionof cells which are foreign to the body). Measurement of properdin factor B aids in the diagnosis of several kidney diseases, e.g., chronic glomerulonephritis (inflammation of the glomeruli of the kidney), lupus nephritis (kidney disease associated with a multisystem autoimmune disease, systemic lupus erythematosus), as well as several skin diseases, e.g., dermatitis herpetiformis (presence of vesicles on the skin that burn and itch), and pemphigus vulgaris (large vesicles on the skin). Other diseases inwhich the alternate pathway of complement activation has been implicated include rheumatoid arthritis, sickle cell anemia, and gram- negative bacteremia.

Official code: C.5330. Product type: Factor XIII, A, S, immunological test system. Official classification: Class 1. A factor XIII, A, S, immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the factor XIII (a bloodclotting factor), in platelets (A) or serum (S). Measurements of factor XIII, A, S, aid in the diagnosis and treatment of certain bleeding disorders resulting from a deficiency of this factor.

Official code: C.5340. Product type: Ferritin immunological test system. Official classification: Class 2. A ferritin immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the ferritin (an iron-storing protein) in serum and other body fluids. Measurements of ferritin aid in the diagnosis of diseases affecting iron metabolism, such as hemochromatosis (iron overload) and iron deficiency anemia.

Official code: C.5350. Product type: Fibrinopeptide A immunological test system. Official classification: Class 2. A fibrinopeptide A immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the fibrinopeptide A (a blood-clotting factor) in plasma and other body fluids. Measurement of fibrinopeptide A may aid in the diagnosis and treatment of certain blood-clotting disorders.

Official code: C.5360. Product type: Cohn fraction IV immunological test system. Official classification: Class 1. A Cohn fraction IV immunological test system is a device that consists of or measures that fraction of plasma proteins, predominantly alpha- and beta-globulins, used as a raw material for the production of pure alpha- or beta-globulins. Measurement of specific alpha- or beta-globulins aids in the diagnosis of many diseases, such as Wilson's disease (an inherited disease affecting the liver and brain), Tangier's disease (absence of alpha-1-lipoprotein), malnutrition, iron deficiency anemia, red blood cell disorders, and kidney disease.

Official code: C.5370. Product type: Cohn fraction V immunological test system. Official classification: Class 1. A Cohn fraction V immunological test system is a device that consists of or measures that fraction of plasma containing predominantly albumin (a plasma protein). This test aids in the diagnosis of diseases where albumin levels may be depressed, e.g., nephrosis (disease of the kidney), proteinuria (protein in the urine), gastroenteropathy (disease of the stomach and small intestine), rheumatoid arthritis, and viral hepatitis.

Official code: C.5380. Product type: Free secretory component immunological test system. Official classification: Class 1. A free secretory component immunological test system is a device that consists of the reagents used to measure by immunochemical techniques free secretory component (normally a portion of the secretory IgA antibody molecule) in body fluids. Measurement of free secretory component (protein molecules) aids in the diagnosis or repetitive lung infections and other hypogammaglobulinemic conditions (low antibody levels).

Official code: C.5400. Product type: Alpha-globulin immunological test system. Official classification: Class 1. An alpha-globulin immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the alpha- globulin (a serum protein) in serum and other body fluids. Measurement of alpha-globulin may aid in the diagnosis of inflammatory lesions, infections, severe burns, and a variety of other conditions.

Official code: C.5420. Product type: Alpha-1-glycoproteins immunological test system. Official classification: Class 1. An alpha-1-glycoproteins immunological test system is a device that consists of the reagents used to measure by immunochemical techniques alpha-1-glycoproteins (a group of plasma proteins found in the alpha-1group when subjected to electrophoresis) in serum and other body fluids. Measurement of specific alpha-1-glycoproteins may aid in the diagnosis of collagen (connective tissue) disorders, tuberculosis, infections, extensive malignancy, and diabetes.

Official code: C.5425. Product type: Alpha-2-glycoproteins immunological test system. Official classification: Class 1. An alpha-2-glycoproteins immunological test system is a device that consists of the reagents used tomeasure by immunochemical techniques the alpha-2-glycoproteins (a group of plasma proteins found in the alpha-2 group when subjected to electrophoresis) in serum and other body fluids. Measurement of alpha-2-glycoproteins aids in the diagnosis of some cancers and genetically inherited deficiencies of these plasma proteins.

Official code: C.5430. Product type: Beta-2-glycoprotein I immunological test system. Official classification: Class 1. A beta-2-glycoprotein I immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the beta-2-glycoprotein I (a serum protein) in serum and other body fluids. Measurement of beta-2-glycoprotein I aids in the diagnosis of an inherited deficiency of this serum protein.

Official code: C.5440. Product type: Beta-2-glycoprotein III immunological test system. Official classification: Class 1. A beta-2-glycoprotein III immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the beta-2-glycoprotein III (a serum protein) in serum and other body fluids. Measurement of beta-2-glycoprotein III aids in the diagnosis of an inherited deficiency of this serum protein and a variety of other conditions.

Official code: C.5460. Product type: Haptoglobin immunological test system. Official classification: Class 1. A haptoglobin immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the haptoglobin (a protein that binds hemoglobin, the oxygen-carrying pigment in red blood cells) in serum. Measurement of haptoglobin may aid in the diagnosis of hemolytic diseases (diseases in which the red blood cells rupture and release hemoglobin) related to the formation of hemoglobin-haptoglobin complexes and certain kidney diseases.

Official code: C.5470. Product type: Hemoglobin immunological test system. Official classification: Class 2. A hemoglobin immunological test system is a device that consists of the reagents used to measure byimmunochemical techniques the different types of free hemoglobin (the oxygen-carrying pigment in red blood cells) in blood, urine, plasma, or other body fluids. Measurements of free hemoglobin aid in the diagnosis of various hematologic disorders, such assickle cell anemia, Fanconi's anemia (a rare inherited disease), aplastic anemia (bone marrow does not produce enough blood cells), and leukemia (cancer of the blood-forming organs).

Official code: C.5490. Product type: Hemopexin immunological test system. Official classification: Class 1. A hemopexin immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the hemopexin (a serum protein that binds heme, a component of hemoglobin) in serum. Measurement of hemopexin aids in the diagnosis of various hematologic disorders, such as hemolytic anemia (anemia due to shortened in vivo survival of mature red blood cells and inability of the bone marrow to compensate for their decreased life span) and sickle cell anemia.

Official code: C.5500. Product type: Hypersensitivity pneumonitis immunological test system. Official classification: Class 2. A hypersensitivity pneumonitis immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the immunoglobulin antibodies in serum which react specifically with organic dust derived from fungal or animal protein sources. When these antibodies react with such dusts in the lung, immune complexes precipitate and trigger an inflammatory reaction (hypersensitivity pneumonitis). Measurement of these immunoglobulin G antibodies aids in the diagnosis of hypersensitivity pneumonitis and other allergic respiratory disorders.

Official code: C.5510. Product type: Immunoglobulins A, G, M, D, andE immunological test system. Official classification: Class 2. An immunoglobulins A, G, M, D, and E immunological test system is a device that consists of the reagents used tomeasure by immunochemical techniques the immunoglobulins A, G, M, D, an E (serum antibodies) in serum. Measurement of these immunoglobulins aids in the diagnosis of abnormal protein metabolism and the body's lack of ability to resist infectious agents.

Official code: C.5520. Product type: Immunoglobulin G (Fab fragment specific) immunological test system. Official classification: Class 1. An immunoglobulin G (Fab fragment specific) immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the Fab antigen-bindingfragment resulting from breakdown of immunoglobulin G antibodies in urine, serum, and other body fluids. Measurement of Fab fragments of immunoglobulin G aids in the diagnosis of lymphoproliferative disorders, such as multiple myeloma (tumor of bone marrowcells), Waldenstrom's macroglobulinemia (increased immunoglobulin production by the spleen and bone marrow cells), and lymphoma (tumor of the lymphoid tissues).

Official code: C.5530. Product type: Immunoglobulin G (Fc fragment specific) immunological test system. Official classification: Class 1. An immunoglobulinG (Fc fragment specific) immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the Fc (carbohydrate containing) fragment of immunoglobulin G (resulting from breakdown of immunoglobulin G antibodies) in urine, serum, and other body fluids. Measurement of immunoglobulin G Fc fragments aids in the diagnosis of plasma cell antibody-forming abnormalities, e.g., gamma heavy chain disease.

Official code: C.5540. Product type: Immunoglobulin G (Fd fragment specific) immunological test system. Official classification: Class 1. An immunoglobulin G (Fd fragment specific) immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the amino terminal (antigen-binding) end (Fd fragment) of the heavy chain (a subunit) of the immunoglobulin antibody molecule in serum. Measurement of immunoglobulin G Fd fragments aids in the diagnosis of plasma antibody-forming cell abnormalities.

Official code: C.5550. Product type: Immunoglobulin (light. Official classification: Class 2. An immunoglobulin (light chain specific) immunological test system is a device that consists of the reagents used to measure by chain specific) immunological test system immunochemical techniques both kappa and lambda types of light chain portions of immunoglobulin molecules in serum, other body fluids, and tissues. In some disease states, an excess of light chains are produced by the antibody-forming cells. These free light chains, unassociated with gamma globulin molecules, can be found in a patient's body fluids and tissues. Measurement ofthe various amounts of the different types of light chains aids in the diagnosis of multiple myeloma (cancer of antibody-forming cells), lymphocytic neoplasms (cancer of lymphoid tissue), Waldenstrom's macroglobulinemia (increased production of large immunoglobulins), and connective tissue diseases such as rheumatoid arthritis or systemic lupus erythematosus.

Official code: C.5560. Product type: Lactic dehydrogenase immunological test system. Official classification: Class 1. A lactic dehydrogenase immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the activity of the lactic dehydrogenase enzyme in serum. Increased levels of lactic dehydrogenase are found in avariety of conditions, including megaloblastic anemia (decrease in the number of mature red blood cells), myocardial infarction(heart disease), and some forms of leukemia (cancer of the blood-forming organs). However, the diagnostic usefulness of this device is limited because of the many conditions known to cause increased lactic dehydrogenase levels.

Official code: C.5570. Product type: Lactoferrin immunological test system. Official classification: Class 1. A lactoferrin immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the lactoferrin (an iron-binding protein with the ability to inhibit the growth of bacteria) in serum, breast milk, other body fluids, and tissues. Measurement of lactoferrin may aid in the diagnosis of an inherited deficiency of this protein.

Official code: C.5580. Product type: Alpha-1-lipoprotein immunological test system. Official classification: Class 2. An alpha-1-lipoprotein immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the alpha-1-lipoprotein (high-density lipoprotein) in serum and plasma. Measurement of alpha-1-lipoprotein may aid in the diagnosis of Tangier disease (a hereditary disorder of fat metabolism).

Official code: C.5590. Product type: Lipoprotein X immunological test system. Official classification: Class 1. A lipoprotein X immunological test system is a device that consists of the reagents used to measure by immunochemical techniques lipoprotein X (a high-density lipoprotein) in serum and other bodyfluids. Measurement of lipoprotein X aids in the diagnosis of obstructive liver disease.

Official code: C.5600. Product type: Low-density lipoprotein immunological test system. Official classification: Class 2. A low-density lipoprotein immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the low-density lipoprotein in serum and other body fluids. Measurement of low-density lipoprotein in serum may aid in the diagnosis of disorders of lipid (fat) metabolism and help to identify young persons at risk from cardiovascular diseases.

Official code: C.5620. Product type: Alpha-2-macroglobulin immunological test system. Official classification: Class 2. An alpha-2-macroglobulin immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the alpha-2-macroglobulin (a serum protein) in plasma. Measurement of alpha-2-macroglobulin may aid in the diagnosis of blood-clotting or clot lysis disorders.

Official code: C.5630. Product type: Beta-2-microglobulin immunological test system. Official classification: Class 2. A beta-2-microglobulin immunological test system is a device that consists ofthe reagents used to measure by immunochemical techniques beta-2-microglobulin (a protein molecule) in serum, urine, and other body fluids. Measurement of beta-2-microglobulin aids in the diagnosis of active rheumatoid arthritis and kidney disease.

Official code: C.5640. Product type: Infectious mononucleosis immunological test system. Official classification: Class 2. An infectious mononucleosis immunological test system is a device that consists of the reagents used to measure by immunochemical techniques heterophile antibodies frequently associated with infectiousmononucleosis in serum, plasma, and other body fluids. Measurements of these antibodies aid in the diagnosis of infectious mononucleosis.

Official code: C.5660. Product type: Multiple autoantibodies immunological test system. Official classification: Class 2. A multiple autoantibodies immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the autoantibodies (antibodies produced against the body's own tissues) in serum and other body fluids. Measurement of multiple autoantibodies aids in the diagnosis of autoimmune disorders (disease produced when the body's own tissues are injured by autoantibodies).

Official code: C.5665. Product type: Aquaporin-4 autoantibody immunological test system. Official classification: Class 2. An Aquaporin-4 autoantibody immunological test system is a device that consists of reagents used to measure by immunochemical techniques autoantibodies in human serum samples that react with Aquaporin-4 (AQP4Ab). The measurements aid in the diagnosis of neuromyelitis optica (NMO) and neuromyelitis optica spectrum disorders (NMOSD) in conjunction with otherclinical, laboratory, and radiological (e.g., magnetic resonance imaging) findings.

Official code: C.5670. Product type: Zinc transporter 8 autoantibody immunological test system. Official classification: Class 2. A zinc transporter 8 autoantibody immunological test system is a device that consists of reagents used to measure, by immunochemical techniques, the autoantibodies in human serum samples that react with Zinc Transporter 8 (ZnT8). The measurements aid in the diagnosis of Type 1 diabetes mellitus (autoimmune mediated diabetes) in conjunction with other clinical and laboratory findings.

Official code: C.5680. Product type: Myoglobin immunological test system. Official classification: Class 2. A myoglobin immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the myoglobin (an oxygen storage protein found in muscle)in serum and other body fluids. Measurement of myoglobin aids in the rapid diagnosis of heart or renal disease.

Official code: C.5700. Product type: Whole human plasma or serum immunological test system. Official classification: Class 1. A whole human plasma or serum immunological test system is a device that consists of reagents used to measure by immunochemical techniques the proteins in plasma or serum. Measurements of proteins in plasma or serum aid in the diagnosis of any disease concerned with abnormal levels of plasma or serum proteins, e.g., agammaglobulinemia, allergies, multiple myeloma, rheumatoid vasculitis, or hereditary angioneurotic edema.

Official code: C.5715. Product type: Plasminogen immunological test system. Official classification: Class 1. A plasminogen immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the plasminogen (an inactive substance from which plasmin, a blood-clotting factor, is formed) in serum, other body fluids, and tissues. Measurement of plasminogen levels may aid in the diagnosis of fibrinolytic (blood-clotting) disorders.

Official code: C.5735. Product type: Prothrombin immunological test system. Official classification: Class 1. A prothrombin immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the prothrombin (clotting factor II) in serum. Measurements of the amount of antigenically competent (ability to react with protein antibodies) prothrombin aid in the diagnosis of blood-clotting disorders.

Official code: C.5750. Product type: Radioallergosorbent (RAST) immunological test system. Official classification: Class 2. A radioallergosorbent immunological test system is a device that consists ofthe reagents used to measure by immunochemical techniques the allergen antibodies (antibodies which cause an allergic reaction) specific for a given allergen. Measurement of specific allergen antibodies may aid in the diagnosis of asthma, allergies, and other pulmonary disorders.

Official code: C.5760. Product type: Tryptase test system. Official classification: Class 2. A tryptase test system is a device that aids in the diagnosis of systemic mastocytosis. It is intended for in vitro diagnostic use as an aid in the clinical diagnosis of patients with a suspicion ofsystemic mastocytosis in conjunction with other clinical and laboratory findings.

Official code: C.5765. Product type: Retinol-binding protein immunological test system. Official classification: Class 1. A retinol-binding protein immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the retinol-binding protein that binds and transports vitamin A in serum and urine. Measurement of this protein may aid in the diagnosis of kidney disease and in monitoring patients with kidney transplants.

Official code: C.5775. Product type: Rheumatoid factor immunological test system. Official classification: Class 2. A rheumatoid factor immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the rheumatoid factor (antibodies to immunoglobulins) in serum, other body fluids, and tissues. Measurement of rheumatoid factor may aid in the diagnosis of rheumatoid arthritis.

Official code: C.5785. Product type: Anti-Saccharomyces cerevisiae (S.cerevisiae) antibody (ASCA) test systems. Official classification: Class 2. The Anti-Saccharomyces cerevisiae (S. cerevisiae) antibody (ASCA) test system is an invitro diagnostic device that consists of the reagents used to measure, by immunochemical techniques, antibodies toS. cerevisiae (baker's or brewer's yeast) in human serum or plasma. Detection of S. cerevisiae antibodies may aid in the diagnosis of Crohn's disease.

Official code: C.5820. Product type: Systemic lupus erythematosus immunological test system. Official classification: Class 2. A systemic lupus erythematosus (SLE) immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the autoimmune antibodies in serum and other body fluids that react with cellular nuclear double- stranded deoxyribonucleic acid (DNA) or other nuclear constituents that are specifically diagnostic of SLE. Measurement of nuclear double-stranded DNA antibodies aids in the diagnosis of SLE (a multisystem autoimmune disease in which tissues are attacked by the person's own antibodies).

Official code: C.5830. Product type: Brain trauma assessment test. Official classification: Class 2. A brain trauma assessment test is a device that consists of reagents used to detect and measure brain injury biomarkers in human specimens. The measurements aid in the evaluation of patients with suspected mild traumatic brain injury in conjunction with other clinical information to assist in determining the need for head imaging per current standard of care.

Official code: C.5860. Product type: Total spinal fluid immunological test system. Official classification: Class 1. A total spinal fluid immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the total protein in cerebrospinal fluid. Measurement of spinal fluid proteinsmay aid in the diagnosis of multiple sclerosis and other diseases of the nervous system.

Official code: C.5870. Product type: Thyroid autoantibody immunological test system. Official classification: Class 2. A thyroid autoantibody immunological test system is a device that consists of the reagents used to measure byimmunochemical techniques the thyroid autoantibodies (antibodies produced against the body's own tissues). Measurement of thyroid autoantibodies may aid in the diagnosis of certain thyroid disorders, such as Hashimoto's disease (chronic lymphocytic thyroiditis), nontoxic goiter (enlargement of thyroid gland), Grave's disease (enlargement of the thyroid gland with protrusion of the eyeballs), and cancer of the thyroid.

Official code: C.5880. Product type: Transferrin immunological test system. Official classification: Class 2. A transferrin immunological test system isa device that consists of the reagents used to measure by immunochemical techniques the transferrin (an iron-binding and transporting serum protein) in serum, plasma, and other body fluids. Measurement of transferrin levels aids in the diagnosis of malnutrition, acute inflammation, infection, and red blood cell disorders, such as iron deficiency anemia.

Official code: C.5890. Product type: Inter-alpha trypsin inhibitor immunological test system. Official classification: Class 1. An inter-alpha trypsin inhibitor immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the inter-alpha trypsin inhibitor (a protein) in serum and other body fluids. Measurement of inter- alpha trypsin inhibitor may aid in the diagnosis of acute bacterial infection and inflammation.

Official code: C.5900. Product type: Cystic fibrosis transmembrane conductance regulator (CFTR) gene mutation detection system. Official classification: Class 2. The CFTR gene mutation detection system is a device used to simultaneously detect and identify a panel of mutations and variants in the CFTR gene. It is intended as an aid in confirmatory diagnostic testing of individuals with suspected cystic fibrosis (CF), carrier identification, and newborn screening. This device is not intended for stand-alone diagnostic purposes, prenatal diagnostic, pre-implantation, or population screening.

Official code: C.5930. Product type: Newborn screening test for severe combined immunodeficiency disorder (SCID). Official classification: Class 2. A newborn screening test for SCID is a device intended to measure T-cell receptor excision circle (TREC) DNA obtained from dried blood spot specimenson filter paper using a polymerase chain reaction based test as an aid in screening newborns for SCID. Presumptive positive results must be followed up by diagnostic confirmatory testing. This test is not intended for use as a diagnostic test, or for screening of SCID-like syndromes, such as DiGeorge syndrome or Omenn syndrome. It is also not intended to screen for less acute SCID syndromes, such as leaky SCID or variant SCID.

Official code: C.5940. Product type: Autosomal recessive carrier screening gene mutation detection system. Official classification: Class 2. Autosomal recessive carrier screening gene mutation detection system is a qualitative in vitro molecular diagnostic system used for genotyping of clinically relevant variants in genomic DNA isolated from human specimens. The device is intended for autosomalrecessive disease carrier screening in adults of reproductive age. The device is not intended for copy number variation, cytogenetic, or biochemical testing.

Official code: C.5950. Product type: Genetic health risk assessment system. Official classification: Class 2. A genetic health risk assessment system is a qualitative in vitro molecular diagnostic system used for detecting variants in genomic deoxyribonucleic acid (DNA) isolated from human specimens that will provide information to users about their genetic risk of developing a disease. This device does not determine the person's overall risk of developing a disease.

Official code: C.6010. Product type: Tumor-associated antigen immunological test system. Official classification: Class 2. A tumor-associated antigen immunological test system is a device that consists of reagents used to qualitatively or quantitatively measure, by immunochemical techniques, tumor-associated antigens in serum, plasma, urine, or other body fluids. This device is intended as an aid in monitoring patients for disease progress or response to therapy or for the detection of recurrent or residual disease.

Official code: C.6020. Product type: Immunomagnetic circulating cancer cell selection and enumeration system. Official classification: Class 2. An immunomagnetic circulating cancer cell selection and enumeration system is a device that consists of biological probes, fluorochromes, and other reagents; preservationand preparation devices; and a semiautomated analytical instrument to select and count circulating cancer cells in a prepared sample of whole blood. This device is intended for adjunctive use in monitoringor predicting cancer disease progression, response to therapy, and for the detection of recurrent disease.

Official code: C.6030. Product type: AFP-L3% immunological test system. Official classification: Class 2. An AFP-L3% immunological test system is an in vitro device that consists of reagents and an automated instrument used to quantitatively measure, by immunochemical techniques, AFP and AFP-L3 subfraction in human serum. The device is intended for in vitro diagnostic use as an aid in the risk assessment of patients with chronic liver disease for development of hepatocellular carcinoma, in conjunction with other laboratory findings, imaging studies, and clinical assessment.

Official code: C.6040. Product type: Gene expression profiling test system for breast cancer prognosis. Official classification: Class 2. A gene expression profiling test system for breast cancer prognosis is a device that measures the ribonucleic acid(RNA) expression level of multiple genes and combines this information to yield a signature (pattern or classifier or index) to aid in prognosis of previously diagnosed breast cancer.

Official code: C.6050. Product type: Ovarian adnexal mass assessment score test system. Official classification: Class 2. An ovarian/adnexal mass assessment test system is a device that measures one or more proteins in serum or plasma. It yields a single result for the likelihood that an adnexal pelvic mass in a woman, for whom surgery is planned, is malignant. The testis for adjunctive use, in the context of a negative primary clinical and radiological evaluation, to augment the identification of patients whose gynecologic surgery requires oncology expertise and resources.

Official code: C.6060. Product type: BCR-ABL quantitation test. Official classification: Class 2. A BCR-ABL quantitation test is identified as a reverse transcription-quantitative polymerase chain reaction (RT-qPCR) test for the quantitation of BCR-ABL1 expressed on the International Scale (IS) and control transcripts in total RNA from whole blood of diagnosed t(9;22) positivechronic myeloid leukemia (CML) patients during monitoring of treatment with tyrosine kinase inhibitors. This test is not intended for the diagnosis of CML.

Official code: C.6080. Product type: Next generation sequencing (NGS) based tumor profiling test. Official classification: Class 2. A next generation sequencing (NGS) based tumor profiling test is a qualitative in vitro diagnostic test intended for NGS analysis of tissue specimens from malignant solid neoplasms to detect somatic mutations in a broad panel of targeted genes to aid in the management of previously diagnosed cancer patients by qualified health care professionals.

Official code: C.9999. Product type: Others(Immunology and Microbiology Device) 1,. Official classification: Class 2,3. The products excluded from the above-classification are adopted in this classification and specified by the central competent health authority.

Official code: D.1040. Product type: Powered algesimeter. Official classification: Class 2. A powered algesimeter is a device using electrical stimulation intended to determine a patient's sensitivity to pain after administration of an anesthetic agent.

Official code: D.1075. Product type: Argon gas analyzer. Official classification: Class 2. An argon gas analyzer is adevice intended to measure the concentration of argon in a gas mixture to aid in determining the patient's ventilatory status. The device may use techniques such as mass spectrometry or thermal conductivity.

Official code: D.1100. Product type: Arterial blood sampling kit. Official classification: Class 2. An arterial blood sampling kit is a device, in kit form, used to obtain arterial blood samples from a patient for blood gas determinations. The kit may include a syringe, needle, cork, and heparin.

Official code: D.1120. Product type: Indwelling blood oxyhemoglobin concentration analyzer. Official classification: Class 3. An indwelling blood oxyhemoglobin concentration analyzer is a photoelectric device used to measure, in vivo, the oxygen-carrying capacity of hemoglobin in blood to aid in determining the patient's physiological status.

Official code: D.1150. Product type: Indwelling blood carbon dioxide partial pressure (PCO 2 ) analyzer. Official classification: Class 2. An indwelling blood carbon dioxide partial pressure PCO 2 analyzer is a device that consists of a catheter-tip PCO 2 transducer (e.g., PCO 2 electrode) and that is used to measure, in vivo, the partial pressure of carbon dioxide in blood to aid in determining the patient's circulatory, ventilatory, and metabolic status.

Official code: D.1170. Product type: Indwelling blood hydrogen ion concentration (pH) analyzer. Official classification: Class 2. An indwelling blood hydrogen ion concentration (pH) analyzer is a device that consists of a catheter-tip pH electrode and that is used to measure, in vivo, the hydrogen ion concentration (pH) in blood to aid in determining the patient's acid-base balance.

Official code: D.1200. Product type: Indwelling blood oxygen partial pressure (PO 2 ) analyzer. Official classification: Class 2. An indwelling blood oxygen partial pressure (PO 2 ) analyzer is a device that consists of a catheter-tip PO 2 transducer (e.g., PO 2 electrode) and that is used to measure, in vivo, the partial pressure of oxygen in blood to aid in determining the patient'scirculatory, ventilatory, and metabolic status.

Official code: D.1400. Product type: Carbon dioxide gas analyzer. Official classification: Class 2. A carbon dioxide gas analyzer is a device intended to measure the concentration of carbon dioxide in a gas mixture to aid in determining the patient's ventilatory, circulatory, and metabolic status. The device may use techniques such as chemical titration, absorption of infrared radiation, gas chromatography, or mass spectrometry.

Official code: D.1430. Product type: Carbon monoxide gas analyzer. Official classification: Class 2. A carbon monoxide gas analyzer is a device intended to measure the concentrationof carbon monoxide in a gas mixture to aid in determining the patient's ventilatory status. The device may use techniques such as infrared absorption or gas chromatography.

Official code: D.1500. Product type: Enflurane gas analyzer. Official classification: Class 2. An enflurane gas analyzer is a device intended to measure the concentration of enflurane anesthetic in a gas mixture.

Official code: D.1505. Product type: Ventilatory electrical impedance tomograph. Official classification: Class 2. A ventilatory electrical impedance tomograph is a non-invasive, non-radiological ventilatory device that provides an assessment of local impedance variation within a cross-section of a patient's thorax.

Official code: D.1575. Product type: Gas collection vessel. Official classification: Class 1. A gas collection vessel is a container-like device intended to collect a patient's exhaled gases for subsequent analysis. It does not include a sampling pump.

Official code: D.1620. Product type: Halothane gas analyzer. Official classification: Class 2. A halothane gas analyzer is a device intended to measure the concentration of halothane anesthetic in a gas mixture. The device may use techniques such as mass spectrometry or absorption of infrared or ultraviolet radiation.

Official code: D.1640. Product type: Helium gas analyzer. Official classification: Class 2. A helium gas analyzer is a device intended to measure the concentration of helium in a gas mixture during pulmonary function testing. The device may use techniques such as thermal conductivity, gas chromatography, or mass spectrometry.

Official code: D.1670. Product type: Neon gas analyzer. Official classification: Class 2. A neon gas analyzer is a device intended to measure the concentration of neon in a gas mixture exhaled by a patient. The device may use techniques such as mass spectrometry or thermal conductivity.

Official code: D.1690. Product type: Nitrogen gas analyzer. Official classification: Class 2. A nitrogen gas analyzer is a device intended to measure the concentration of nitrogen in respiratory gases to aid in determining a patient's ventilatory status. The device may use techniques such as gas chromatography or mass spectrometry.

Official code: D.1700. Product type: Nitrous oxide gas analyzer. Official classification: Class 2. A nitrous oxide gas analyzer is a device intended to measure the concentration of nitrous oxide anesthetic in a gas mixture.The device may use techniques such as infrared absorption or mass spectrometry.

Official code: D.1720. Product type: Oxygen gas analyzer. Official classification: Class 2. An oxygen gas analyzer is a device intended to measure the concentration of oxygen in respiratory gases by techniques such as mass spectrometry, polarography, thermal conductivity, or gas chromatography. This generic type of device also includes paramagnetic analyzers.

Official code: D.1730. Product type: Oxygen uptake computer. Official classification: Class 2. An oxygen uptake computer is a device intended to compute the amount of oxygen consumed by a patient and may include components for determining expired gas volume and composition.

Official code: D.1750. Product type: Pressure plethysmograph. Official classification: Class 2. A pressure plethysmograph is a device used to determine a patient's airway resistance and lung volumes by measuring pressure changes while the patient is in an airtight box.

Official code: D.1760. Product type: Volume plethysmograph. Official classification: Class 2. A volume plethysmograph is an airtight box, in which a patient sits, that is used to determine the patient's lung volume changes.

Official code: D.1780. Product type: Inspiratory airway pressure meter. Official classification: Class 2. An inspiratory airway pressure meter is a device used to measure the amount of pressure produced in a patient's airway during maximal inspiration.

Official code: D.1800. Product type: Rhinoanemometer. Official classification: Class 2. A rhinoanemometer is a device used to quantify the amount of nasal congestion by measuring the airflow through, and differential pressure across, a patient's nasal passages.

Official code: D.1840. Product type: Diagnostic spirometer. Official classification: Class 2. A diagnostic spirometer is a device used in pulmonary function testing to measure the volume of gas moving in or out of a patient's lungs.

Official code: D.1850. Product type: Monitoring spirometer. Official classification: Class 2. A monitoring spirometer is a device used to measure continuously a patient's tidal volume (volume of gas inhaled by the patient during each respiration cycle) or minute volume (the tidal volume multiplied by the rate of respiration for 1 minute) for the evaluation of the patient's ventilatory status.

Official code: D.1860. Product type: Peak-flow meter for spirometry. Official classification: Class 2. A peak-flow meter for spirometry is a device used to measure a patient's maximum ventilatory flow rate.

Official code: D.1880. Product type: Pulmonary-function data calculator. Official classification: Class 2. A pulmonary-function data calculator is a device used to calculate pulmonary-function values based on actual physical data obtained during pulmonary-function testing.

Official code: D.1890. Product type: Predictive pulmonary- function value calculator. Official classification: Class 2. A predictive pulmonary-function value calculator is a device used to calculate normal pulmonary-function values based on empirical equations.

Official code: D.1900. Product type: Diagnostic pulmonary- function interpretation calculator. Official classification: Class 2. A diagnostic pulmonary-function interpretation calculator is a device that interprets pulmonary study data to determine clinical significance of pulmonary-function values.

Official code: D.1910. Product type: Esophageal stethoscope. Official classification: Class 1. An esophageal stethoscope is a nonpowered device that is inserted into a patient's esophagus to enable the user to listen toheart and breath sounds.

Official code: D.1920. Product type: Esophageal stethoscope with electrical conductors. Official classification: Class 2. An esophageal stethoscope with electrical conductors is a device that is inserted into the esophagus to listen to a patient's heart and breath sounds and to monitor electrophysiological signals. The device may also incorporate a thermistor for temperature measurement.

Official code: D.1930. Product type: Stethoscope head. Official classification: Class 1. A stethoscope head is a weighted chest piece used during anesthesia to listen to a patient's heart, breath, and other physiological sounds.

Official code: D.1975. Product type: Water vapor analyzer. Official classification: Class 1. A water vapor analyzer is a device intended to measure the concentration of water vapor in a patient's expired gases by using techniques such as mass spectrometry.

Official code: D.2025. Product type: Ultrasonic air embolism monitor. Official classification: Class 2. An ultrasonic air embolism monitor is a device used to detect air bubbles in a patient's blood stream. It may use Doppler or other ultrasonic principles.

Official code: D.2300. Product type: Bourdon gauge flowmeter. Official classification: Class 1. A bourdon gauge flowmeter is a device intended for medical purposes that is used in conjunction with respiratory equipment to sense gas pressure. The device is calibrated to indicate gas flow rate when the outflow is open to the atmosphere.

Official code: D.2320. Product type: Uncompensated thorpe tube flowmeter. Official classification: Class 1. An uncompensated thorpe tube flowmeter is a device intended for medical purposes that is used to indicate and control gas flow rate accurately.The device includes a vertically mounted tube and is calibrated when the outlet of the flowmeter is open to the atmosphere.

Official code: D.2340. Product type: Compensated thorpe tube flowmeter. Official classification: Class 1. A compensated thorpe tube flowmeter is a device intended for medical purposes that is used to control and measure gas flow rate accurately. The device includes a vertically mounted tube, with the outlet of the flowmeter calibrated to a reference pressure.

Official code: D.2375. Product type: Breathing frequency monitor. Official classification: Class 2. A breathing (ventilatory) frequency monitor is a device intended to measure or monitor a patient's respiratory rate. The device may provide an audible or visible alarm when the respiratory rate, averaged over time, is outside operator settable alarm limits.This device does not include apnea monitors.

Official code: D.2377. Product type: Apnea monitor. Official classification: Class 2. An apnea monitor is a complete system intended to alarm primarily upon the cessation of breathing timed from the last detected breath. The apnea monitor also includes indirect methods of apnea detection such as monitoring of heart rateand other physiological parameters linked to the presence or absence of adequate respiration.

Official code: D.2380. Product type: Nitric oxide analyzer. Official classification: Class 2. The nitric oxide analyzer is a device intended to measure the concentration of nitric oxide in respiratory gas mixtures during administration of nitric oxide.

Official code: D.2385. Product type: Nitric dioxide analyzer. Official classification: Class 2. The nitrogen dioxide analyzer is a device intended to measure the concentration of nitrogen dioxide in respiratory gas mixtures during administration of nitric oxide.

Official code: D.2450. Product type: Lung water monitor. Official classification: Class 3. A lung water monitor is a device used to monitor the trend of fluid volume changes in a patient's lung by measuring changes in thoracic electrical impedance (resistance to alternating current) by means of electrodes placed on the patient's chest.

Official code: D.2480. Product type: Cutaneous carbon dioxide (PcCO2) monitor. Official classification: Class 2. A cutaneous carbon dioxide (PcCO2) monitor is a noninvasive heated sensor and a pH-sensitive glass electrode placed on a patient's skin, which is intended to monitor relative changes in a hemodynamically stablepatient's cutaneous carbon dioxide tension as an adjunct to arterial carbon dioxide tension measurement.

Official code: D.2500. Product type: Cutaneous oxygen (PcO2) monitor. Official classification: Class 2. A cutaneous oxygen (PcO2) monitor is a noninvasive, heated sensor (e.g., a Clark-type polargraphic electrode) placed on the patient's skin that is intended to monitor relative changes in the cutaneous oxygen tension.

Official code: D.2550. Product type: Pneumotachometer. Official classification: Class 2. A pneumotachometer is a device intended for medical purposes that is used to determine gas flow by measuring the pressure differential across a known resistance. The device may use a set of capillaries or a metal screen for the resistive element.

Official code: D.2600. Product type: Airway pressure monitor. Official classification: Class 2. An airway pressure monitor is a device used to measure the pressure in a patient's upper airway. The device may include a pressure gauge and an alarm.

Official code: D.2610. Product type: Gas pressure gauge. Official classification: Class 1. A gas pressure gauge (e.g.,bourdon tube pressure gauge) is a device intended for medical purposes that is used to measure gas pressure in a medical gas delivery system.

Official code: D.2700. Product type: Pressure regulator. Official classification: Class 1. A pressure regulator is a device, often called a pressure-reducing valve, that is intended for medical purposes and that is used to convert a medical gas pressure from a high variable pressure to a lower, more constant working pressure. This device includes mechanical oxygen regulators.

Official code: D.2775. Product type: Electrical peripheral nerve stimulator. Official classification: Class 2. An electrical peripheral nerve stimulator (neuromuscular blockade monitor) is a device used to apply an electrical current toa patient to test the level of pharmacological effect of anesthetic drugs and gases.

Official code: D.2875. Product type: Differential pressure transducer. Official classification: Class 1. A differential pressure transducer is a two-chambered device intended for medical purposes that is often used during pulmonary function testing. It generates an electrical signal for subsequent display or processing that is proportional to the difference in gas pressures in the two chambers.

Official code: D.2885. Product type: Gas flow transducer. Official classification: Class 1. A gas flow transducer is a device intended for medical purposes that is used to convert gas flow rate into an electrical signal for subsequent display or processing.

Official code: D.2900. Product type: Gas pressure transducer. Official classification: Class 1. A gas pressure transducer is a device intended for medical purposes that is used to convert gas pressure into an electrical signal for subsequent display or processing.

Official code: D.5090. Product type: Emergency airway needle. Official classification: Class 2. An emergency airway needle is a device intended to puncture a patient's cricothyroid membrane to provide an emergency airway during upper airway obstruction.

Official code: D.5100. Product type: Nasopharyngeal airway. Official classification: Class 1. A nasopharyngeal airway is a device used to aid breathing by means of a tube inserted into a patient's pharynx through the noseto provide a patent airway.

Official code: D.5105. Product type: External negative pressure airway aid. Official classification: Class 2. An external negative pressure airway aid is a devicethat applies negative pressure to a patient's neck to aid in providing a patent airway during procedures requiring anesthesia.

Official code: D.5110. Product type: Oropharyngeal airway. Official classification: Class 1. An oropharyngeal airway is a device inserted into a patient's pharynx through the mouth to provide a patent airway.

Official code: D.5115. Product type: Device to relieve acute upper airway obstruction. Official classification: Class 2. The device is a raised, rounded pad that, in the event of choking on a foreign body, can be applied to the abdomen and pushed upward to generate expulsion pressure to remove the obstruction to relieve acute upper airway obstruction.

Official code: D.5120. Product type: Anesthesia conduction catheter. Official classification: Class 2. An anesthesia conduction catheter is a flexible tubular device used to inject local anesthetics into a patient and to provide continuous regional anesthesia.

Official code: D.5130. Product type: Anesthesia conduction filter. Official classification: Class 2. An anesthesia conduction filter is a microporous filter used while administering to a patient injection of local anestheticsto minimize particulate (foreign material) contamination of the injected fluid.

Official code: D.5140. Product type: Anesthesia conduction kit. Official classification: Class 2. An anesthesia conduction kit is a device used to administer to a patient conduction, regional, or local anesthesia. The device may contain syringes, needles, and drugs.

Official code: D.5150. Product type: Anesthesia conduction needle. Official classification: Class 2. An anesthesia conduction needle is a device used to inject local anesthetics into a patient to provide regional anesthesia.

Official code: D.5160. Product type: Gas machine for anesthesia. Official classification: Class 2. (a) Gas machine for anesthesia. A gas machine for anesthesia is a device used to administer to a patient, continuously or or analgesiaintermittently, a general inhalation anesthetic and to maintain a patient's ventilation. The device may include a gas flowmeter, vaporizer, ventilator, breathing circuit with bag, and emergency air supply. (b) Gas machine for analgesia. A gas machine for analgesia is a device used to administer to a patient an analgesic agent, such as a nitrous oxide-oxygen mixture (maximum concentration of 70 percent nitrous oxide).

Official code: D.5165. Product type: Nitric oxide administration apparatus. Official classification: Class 2. The nitric oxide administration apparatus is a device used to add nitric oxide to gases that are to be breathed by a patient. The nitric oxide administration apparatus is to be used in conjunction with a ventilator or other breathing gas administration system.

Official code: D.5170. Product type: Laryngotracheal topical anesthesia applicator. Official classification: Class 2. A laryngotracheal topical anesthesia applicator is a device used to apply topical anesthetics to a patient's laryngotracheal area.

Official code: D.5180. Product type: Rocking bed. Official classification: Class 2. A rocking bed is a device intended for temporary use to help patient ventilation (breathing) by repeatedly tilting the patient, thereby using the weight of the abdominal contents to move the diaphragm.

Official code: D.5220. Product type: Blow bottle. Official classification: Class 1. A blow bottle is a device that is intended for medical purposes to induce a forced expiration from a patient. The patient blows into the device to move a column of water from one bottle to another.

Official code: D.5240. Product type: Anesthesia breathing circuit. Official classification: Class 1. An anesthesia breathing circuit is a device that is intended to administer medical gases to a patient during anesthesia.It provides both an inhalation and exhalation route and may include a connector, adaptor, and Y-piece.

Official code: D.5250. Product type: Breathing circuit circulator. Official classification: Class 2. A breathing circuit circulator is a turbine device that is attached to a closed breathing circuit and that is intended to circulate anesthetic gases continuously by maintaining the unidirectional valves in an open position and reducing mechanical dead space and resistance in the breathing circuit.

Official code: D.5260. Product type: Breathing circuit bacterial filter. Official classification: Class 2. A breathing circuit bacterial filter is a device that is intended to remove microbiological and particulate matter from the gases in the breathing circuit.

Official code: D.5270. Product type: Breathing system heater. Official classification: Class 2. A breathing system heater is a device that is intended to warm breathing gases before they enter a patient's airway. The device may include a temperature controller.

Official code: D.5273. Product type: Positive airway pressure delivery system. Official classification: Class 2. A positive airway pressure delivery system is a noninvasive ventilatory device that delivers expiratory positive airway pressure for patients suffering from obstructive sleep apnea. The system also provides positive airway pressure during incipient apnea.The system may include a dedicated flow generator and a patient interface.

Official code: D.5280. Product type: Breathing tube support. Official classification: Class 1. A breathing tube support is a device that is intended to support and anchor a patient's breathing tube(s).

Official code: D.5300. Product type: Carbon dioxide absorbent. Official classification: Class 1. A carbon dioxide absorbent is a device intended for medical purposes that consists of an absorbent material (e.g.,soda lime) that is intended to remove carbon dioxide from the gases in the breathing circuit.

Official code: D.5310. Product type: Carbon dioxide absorber. Official classification: Class 1. A carbon dioxide absorber is a device that is intended for medical purposes and that is used in a breathing circuit as a container for carbon dioxide absorbent. It may include a canister and water drain.

Official code: D.5320. Product type: Reservoir bag. Official classification: Class 1. A reservoir bag is a device, usually made of conductive rubber, intended for use in a breathing circuit as a reservoir for breathing gas and to assist, control, or monitor a patient's ventilation.

Official code: D.5330. Product type: Breathing gas mixer. Official classification: Class 2. A breathing gas mixer is a device intended for use in conjunction with a respiratory support apparatus to control the mixingof gases that are to be breathed by a patient.

Official code: D.5340. Product type: Nasal oxygen cannula. Official classification: Class 1. A nasal oxygen cannula is a two-pronged device used to administer oxygen to a patient through both nostrils.

Official code: D.5350. Product type: Nasal oxygen catheter. Official classification: Class 1. A nasal oxygen catheter is a device intended to be inserted through a patient's nostril to administer oxygen.

Official code: D.5375. Product type: Heat and moisture condenser (artificial nose). Official classification: Class 1. A heat and moisture condenser (artificial nose) is a device intended to be positioned over a tracheotomy (a surgically created opening in the throat) or tracheal tube (a tube inserted into the trachea) to warm and humidify gases breathed in by a patient.

Official code: D.5400. Product type: Electroanesthesia apparatus. Official classification: Class 3. An electroanesthesia apparatus is a device used for the induction and maintenance of anesthesia during surgical procedures by means of an alternating or pulsed electric current that is passed through electrodes fixed to a patient's head.

Official code: D.5430. Product type: Gas-scavenging apparatus. Official classification: Class 2. A gas-scavenging apparatus is a device intended to collect excess anesthetic, analgesic, or trace gases or vapors from a patient's breathing system, ventilator, or extracorporeal pump-oxygenator, and to conduct these gases out of the area by means of an exhaust system.

Official code: D.5440. Product type: Portable oxygen generator. Official classification: Class 2. A portable oxygen generator is a device that is intended to release oxygen for respiratory therapy by means of either a chemical reaction or physical means (e.g., a molecular sieve).

Official code: D.5450. Product type: Respiratory gas humidifier. Official classification: Class 2. A respiratory gas humidifier is a device that is intended to add moisture to, and sometimes to warm, the breathing gases for administration to a patient. Cascade, gas, heated, and prefilled humidifiers are included in this generic type of device.

Official code: D.5454. Product type: High flow humidified oxygen delivery device. Official classification: Class 2. A high flow humidified oxygen delivery device is a device that delivers high flow oxygen with humidification for patients who are suffering from respiratory distress and/or hypoxemia.

Official code: D.5460. Product type: Therapeutic humidifier for home use. Official classification: Class 1. A therapeutic humidifier for home use is a device that adds water vapor to breathing gases and that is intended for respiratory therapy or other medical purposes. The vapor produced by the device pervades the area surrounding the patient, who breathes the vapor during normal respiration.

Official code: D.5470. Product type: Hyperbaric chamber. Official classification: Class 2. A hyperbaric chamber is a device that is intended to increase the environmental oxygen pressure to promote the movement of oxygen from the environment to a patient's tissue by means of pressurization that is greater than atmospheric pressure. Thisdevice does not include topical oxygen chambers for extremities (I.5650).

Official code: D.5530. Product type: Flexible laryngoscope. Official classification: Class 1. A flexible laryngoscope is a fiberoptic device used to examine and visualize a patient's upper airway and aid placement of atracheal tube.

Official code: D.5540. Product type: Rigid laryngoscope. Official classification: Class 1. A rigid laryngoscope is a device used to examine and visualize a patient's upper airway and aid placement of a tracheal tube.

Official code: D.5550. Product type: Anesthetic gas mask. Official classification: Class 1. An anesthetic gas mask is a device, usually made of conductive rubber, that is positioned over a patient's nose or mouth to direct anesthetic gases to the upper airway.

Official code: D.5560. Product type: Gas mask head strap. Official classification: Class 1. A gas mask head strap is a device used to hold an anesthetic gas mask in position on a patient's face.

Official code: D.5570. Product type: Nonrebreathing mask. Official classification: Class 1. A nonrebreathing mask is a device fitting over a patient's face to administer oxygen. It utilizes one-way valves to prevent the patient from rebreathing previously exhaled gases.

Official code: D.5580. Product type: Oxygen mask. Official classification: Class 1. An oxygen mask is a device placed over a patient's nose, mouth, or tracheostomy to administer oxygen or aerosols.

Official code: D.5590. Product type: Scavenging mask. Official classification: Class 1. A scavenging mask is a device positioned over a patient's nose to deliver anesthetic or analgesic gases to the upper airway and to remove excess and exhaled gas. It is usually used during dentistry.

Official code: D.5600. Product type: Venturi mask. Official classification: Class 1. A venturi mask is a device containing an air-oxygen mixing mechanism that dilutes 100 percent oxygen to a predetermined concentration and delivers the mixed gases to a patient.

Official code: D.5610. Product type: Membrane lung for long- term pulmonary support. Official classification: Class 3. A membrane lung for long-term pulmonary support is a device used to provide to a patient extracorporeal blood oxygenation for longer than 24 hours.

Official code: D.5620. Product type: Breathing mouthpiece. Official classification: Class 1. A breathing mouthpiece is a rigid device that is inserted into a patient's mouth and that connects with diagnostic or therapeutic respiratory devices.

Official code: D.5630. Product type: Nebulizer. Official classification: Class 2. A nebulizer is a device intended to spray liquids in aerosol form into gases that are delivered to lower respiratory tract ofthe patient. This device may contain a baffle to generate homogeneous downsized aerosol. Heated, ultrasonic, gas, venturi, and refillable nebulizers are included in this generic type of device.

Official code: D.5640. Product type: Medicinal nonventilatory nebulizer (atomizer). Official classification: Class 1. A medicinal nonventilatory nebulizer (atomizer) is a device that is intended to spray liquid medication in aerosol form that are delivered to upper respiratory tract of the patient.

Official code: D.5650. Product type: Esophageal obturator. Official classification: Class 2. An esophageal obturator is a device inserted through a patient's mouth to aid ventilation of the patient during emergency resuscitation by occluding (blocking) the esophagus, thereby permitting positive pressure ventilation through the trachea. The device consists of a closed-end semirigid esophageal tube that is attached to a face mask.

Official code: D.5665. Product type: Powered percussor. Official classification: Class 2. A powered percussor is a device that is intended to transmit vibration through a patient's chest wall to aid in freeing mucus deposits in the lung in order to improve bronchial drainage and that may be powered by electricity or compressed gas.

Official code: D.5675. Product type: Rebreathing device. Official classification: Class 1. A rebreathing device is a device that enables a patient to rebreathe exhaled gases. It may be used in conjunction with pulmonary function testing or for increasing minute ventilation.

Official code: D.5690. Product type: Incentive spirometer. Official classification: Class 2. An incentive spirometer is a device that indicates a patient's breathing volume or flow and that provides an incentive to the patient to improve his or her ventilation.

Official code: D.5700. Product type: Nonpowered oxygen tent. Official classification: Class 1. A nonpowered oxygen tent is a device that encloses a patient's head and upper body to contain oxygen delivered to the patient for breathing. This generic type of device includes infant oxygen hoods.

Official code: D.5710. Product type: Electrically powered oxygen tent. Official classification: Class 2. An electrically powered oxygen tent is a device that encloses a patient's head and, by means of an electrically powered unit, administers breathing oxygen and controls the temperature and humidity of the breathing gases. This generic type device includes the pediatric aerosol tent.

Official code: D.5720. Product type: Bronchial tube. Official classification: Class 2. A bronchial tube is a device used to differentially intubate a patient's bronchus (one of the two main branches of the trachea leading directly to the lung) in order to isolate a portion of lung distal to the tube.

Official code: D.5730. Product type: Tracheal tube. Official classification: Class 2. A tracheal tube is a device inserted into a patient's trachea via the nose or mouth and used to maintain an open airway.

Official code: D.5740. Product type: Tracheal/bronchial differential ventilation tube. Official classification: Class 2. A tracheal/bronchial differential ventilation tube is a device used to isolate the left or the right lung of a patient for anesthesia or pulmonary function testing.

Official code: D.5750. Product type: Inflatable tracheal tube cuff. Official classification: Class 2. An inflatable tracheal tube cuff is a device used to provide an airtight seal between a tracheal tube and a patient's trachea.

Official code: D.5770. Product type: Tracheal tube fixation device. Official classification: Class 1. A tracheal tube fixation device is a device used to hold a tracheal tube in place, usually by means of straps or pinch rings.

Official code: D.5780. Product type: Tube introduction forceps. Official classification: Class 1. Tube introduction forceps (e.g., Magill forceps) are a right-angled device used to grasp a tracheal tube and place it in a patient's trachea.

Official code: D.5790. Product type: Tracheal tube stylet. Official classification: Class 1. A tracheal tube stylet is a device used temporarily to make rigid a flexible tracheal tube to aid its insertion into a patient.

Official code: D.5800. Product type: Tracheostomy tube and tube cuff. Official classification: Class 2. A tracheostomy tube and tube cuff is a device intended to be placed into a surgical opening of the trachea to facilitate ventilation to the lungs. The cuff may be a separate or integral part of the tracheostomy tube and is, when inflated, intended to establish a seal between the tracheal wall andthe tracheostomy tube. The cuff is used to prevent the patient's aspiration of substances, such as blood or vomit, or to provide a means for positive-pressure ventilation of the patient. This device is made of either stainless steel or plastic.

Official code: D.5810. Product type: Airway connector. Official classification: Class 1. An airway connector is a device intended to connect a breathing gas source to a tracheal tube, tracheostomy tube, or mask.

Official code: D.5830. Product type: Autotransfusion apparatus. Official classification: Class 2. An autotransfusion apparatus is a device used to collect and reinfuse the blood lost by a patient due to surgery or trauma.

Official code: D.5860. Product type: Pressure tubing and accessories. Official classification: Class 1. Pressure tubing and accessories are flexible or rigid devices intended to deliver pressurized medical gases.

Official code: D.5870. Product type: Nonrebreathing valve. Official classification: Class 2. A nonrebreathing valve is a one-way valve that directs breathing gas flow to the patient and vents exhaled gases into the atmosphere.

Official code: D.5880. Product type: Anesthetic vaporizer. Official classification: Class 2. An anesthetic vaporizer is a device used to vaporize liquid anesthetic and deliver a controlled amount of the vapor to the patient.

Official code: D.5895. Product type: Continuous ventilator and accessories. Official classification: Class 2. A continuous ventilator (respirator) and accessories is a device intended to mechanically control or assist patient breathingby delivering a predetermined percentage of oxygen in the breathing gas.Adult, pediatric, and neonatal ventilators are included in this generic type of device. Face masks intended to be used with continuous ventilators are included in this classification.

Official code: D.5905. Product type: Noncontinuous ventilator (IPPB) and accessories. Official classification: Class 2. A noncontinuous ventilator (intermittent positive pressure breathing-IPPB) and accessories are the device intended to deliver intermittently an aerosol to a patient's lungs or to assist a patient's breathing. This device is intended to use with accessories such as masks of noncontinuous ventilator.

Official code: D.5915. Product type: Manual emergency. Official classification: Class 2. A manual emergency ventilator is a device, usually incorporating a bag and valve, intended to provide emergency respiratory ventilatorsupport by means of a face mask or a tube inserted into a patient's airway.

Official code: D.5925. Product type: Powered emergency ventilator. Official classification: Class 2. A powered emergency ventilator is a demand valve or inhalator intended to provide emergency respiratory support by means of a face mask or a tube inserted into a patient's airway.

Official code: D.5935. Product type: External negative pressure ventilator. Official classification: Class 2. An external negative pressure ventilator (e.g.,iron lung, cuirass) is a device chamber that is intended to support a patient's ventilation by alternately applying and releasing external negative pressure over the diaphragm and upper trunk of the patient.

Official code: D.5955. Product type: Intermittent mandatory ventilation attachment. Official classification: Class 2. An intermittent mandatory ventilation (IMV) attachment is a device attached to a mechanical ventilator that allows spontaneous breathing by a patient while providing mechanical ventilation at a preset rate.

Official code: D.5965. Product type: Positive end expiratory pressure breathing attachment. Official classification: Class 2. A positive end expiratory pressure (PEEP) breathing attachment is a device attached to a ventilator that is used to elevate pressure in a patient's lungs above atmospheric pressure at the end of exhalation.

Official code: D.5975. Product type: Ventilator tubing. Official classification: Class 1. Ventilator tubing is a device intended for use as a conduit for gases between a ventilator and a patient during ventilation of the patient.

Official code: D.5995. Product type: Tee drain (water trap). Official classification: Class 1. A tee drain (water trap) is a device intended to trap and drain water that collects in ventilator tubing during respiratory therapy, thereby preventing an increase in breathing resistance.

Official code: D.6250. Product type: Portable air compressor. Official classification: Class 2. A portable air compressor is a device intended to provide compressed air for medical purposes, e.g.,to drive ventilators and other respiratory devices.

Official code: D.6810. Product type: Tracheobronchial suction catheter. Official classification: Class 1. A tracheobronchial suction catheter is a device used to aspirate liquids or semisolids from a patient's upper airway.

Official code: D.6885. Product type: Medical gas yoke assembly. Official classification: Class 1. A medical gas yoke assembly is a device intended to connect medical gas cylinders to regulators or needle valves to supply gases for anesthesia or respiratory therapy. The device may include a particulate filter.

Official code: D.9999. Product type: Others(Anesthesiology Devices) 1,. Official classification: Class 2,3. The products excluded from the above-classification are adopted in this classification and specified by the central competent health authority.

Official code: E.0001. Product type: Cardiovascular stent. Official classification: Class 3. Cardiovascular stent is atube device which is intended to permanent implanted in human vessel or artificial vessel. This device provides mechanical support to maintain vessel patency. Depending on the placement mechanism, these devices include balloon- expanding stents and self-expanding stents. Classification:(1) Class 2 devices intended to be placed in peripheral arteries. For example renal stents, iliac stents, superficial femoral artery stents;(2) Class 3 devices intended to be placed other than peripheral arteries. For example, coronary stents, and carotid stents.

Official code: E.0002. Product type: Cardiovascular excimer laser system. Official classification: Class 3. Cardiovascular excimer laser system is intended for the photoablation or debulking of vascular lesion material (blockages, total occlusions). This device is used with an atherectomy catheter and typically consists of an electrical unit with a display, controls, and/or foot-switch and excimer laser generator.

Official code: E.0004. Product type: Heart preservation/transport. Official classification: Class 2. A heart preservation/transport system is a device designed to maintain donatedheart in an almost physiological state until the heart systemtransplant to the recipient.

Official code: E.0005. Product type: Percutaneous transluminal coronary angioplasty (PTCA) catheter. Official classification: Class 2,3. (a)Standard PTCA catheter (1) Identification: The distal balloon structure is filled with liquid pressure and has a single or dual lumen shaft with a polymer balloon configuration for clinical use. The balloon is designed to expand to a specified diameter and length at a specified pressure, depending on the rate of expansion and contraction and a defined burst pressure. The balloon is marked with an opaque line to identify the position. It is suitable for balloon expansion therapy in coronary arteries or bypass surgically implanted vascular stenoses to improve myocardial perfusion. It may also be used to treat acute myocardial infarction, in-stent restenosis (ISR), and/or post-stenting dilatation.(2) Classification: Class 2. (b)Cutting/scoring PTCA catheter (1) Identification: The balloon catheter has a cutting unit attached, which is used to restrict the lesion with a high pressure balloon. It is indicated for the treatment of coronary stenosis to improve myocardial perfusion and may also be used to treat C-complex lesions or in-stent restenosis (ISR). (2) Classification: Class 3.

Official code: E.0006. Product type: Endovascular graft system. Official classification: Class 3. An endovascular graft system is a device partially or completely placed in the human or artificial blood vessels. This deviceis intended for the revision of arteriovenous access circuits to maintain or re-establish vascular access. Thisdevice is deployed through the vessel circuit. Endovascular graft systems for aortic aneurysm treatment and arteriovenous (AV) dialysis access circuit stenosis treatment are included in this classification.

Official code: E.0008. Product type: Percutaneous cardiac ablation system. Official classification: Class 2,3. A percutaneous cardiac ablation system is intended for cardiac ablation surgery. This system contains percutaneous cardiac ablation catheter, RF ablation generator, cryoablation system, cooling catheter and cooling pump. Catheter remote control system is not included in this classification. Classification: (1) Class 2: RF ablation generator, cryoablation system, cooling catheter and cooling pump. (2) Class 3: percutaneous cardiac ablation catheter.

Official code: E.1025. Product type: Arrhythmia detector and alarm. Official classification: Class 3. The arrhythmia detector and alarm device monitor an electrocardiogram and is designed to produce a visible or audible signal or alarm when atrial or ventricular arrhythmia, such as premature contraction or ventricular fibrillation, occurs.

Official code: E.1100. Product type: Blood pressure alarm. Official classification: Class 2. A blood pressure alarm is a device that accepts the signal from a blood pressure transducer amplifier, processes the signal, and emits an alarm when the blood pressure falls outside a pre-set upper or lower limit.

Official code: E.1110. Product type: Blood pressure computer. Official classification: Class 2. A blood pressure computer is a device that accepts the electrical signal from a blood pressure transducer amplifier and indicates the systolic, diastolic, or mean pressure based on the input signal.

Official code: E.1120. Product type: Blood pressure cuff. Official classification: Class 2. A blood pressure cuff is a device thathas an inflatable bladder in an inelastic sleeve (cuff) with a mechanism for inflating and deflating the bladder. The cuff is used in conjunction with another device to determine a subject's blood pressure.

Official code: E.1130. Product type: Noninvasive blood pressure measurement system. Official classification: Class 2. A noninvasive blood pressure measurement system is a device that provides a signal from which systolic, diastolic, mean, or any combination of the three pressures can be derived through the use of transducers placed on the surface of the body.

Official code: E.1140. Product type: Venous blood pressure manometer. Official classification: Class 2. A venous blood pressure manometer is a device attached to a venous catheter to indicate manometrically the central or peripheral venous pressure.

Official code: E.1200. Product type: Diagnostic intravascular. Official classification: Class 2. An intravascular diagnostic catheter is a device used to record intracardiac pressures, to sample blood, and to introduce substances catheterinto the heart and vessels. Included in this generic device are right-heart catheters, left-heart catheters, and angiographic catheters, among others.

Official code: E.1210. Product type: Continuous flush catheter. Official classification: Class 2. A continuous flush catheter is an attachment to a catheter-transducer system that permits continuous intravascular flushing at a slow infusion rate for the purpose of eliminating clotting, back-leakage, and waveform damping.

Official code: E.1220. Product type: Electrode recording catheter or electrode recording probe. Official classification: Class 2. An electrode recording catheter or an electrode recording probe is a device used to detect an intracardiac electrocardiogram,or to detect cardiac output or left-to-right heart shunts.The device may be unipolar or multipolar for electrocardiogram detection, or may be a platinum-tipped catheter which senses the presence of a special indicator for cardiac output or left-to-right heart shunt determinations.

Official code: E.1230. Product type: Fiberoptic oximeter catheter. Official classification: Class 2. A fiberoptic oximeter catheter is a device used to estimate the oxygen saturation of the blood. It consists of two fiberopticbundles that conduct light at a desired wavelength through blood and detect the reflected and scattered light at the distal end of the catheter.

Official code: E.1240. Product type: Flow-directed catheter. Official classification: Class 2. A flow-directed catheter is a device that incorporates a gas-filled balloon to help direct the catheter to the desired position.

Official code: E.1250. Product type: Percutaneous catheter. Official classification: Class 2. A percutaneous catheter is a device that is introduced into a vein or artery through the skin using a dilator and a sheath (introducer) or guide wire.

Official code: E.1251. Product type: Temporary catheter for embolic protection during transcatheter intracardiac procedures. Official classification: Class 2. This device is a single use percutaneous catheter system that has (a) blood filter(s) at the distal end. This device is indicated for use while performing transcatheter intracardiac procedures. The device is used to filter blood in a manner that may prevent embolic material (thrombus/debris) from the transcatheter intracardiac procedure from traveling towards the cerebral circulation.

Official code: E.1255. Product type: Balloon aortic valvuloplasty catheter. Official classification: Class 2. A balloon aortic valvuloplasty catheter is a catheter with a balloon at the distal end of the shaft, which is intended to treat stenosis in the aortic valve when the balloon is expanded.

Official code: E.1270. Product type: Intracavitary phonocatheter system. Official classification: Class 2. An intracavitary phonocatheter system is a system that includes a catheter with an acoustic transducer and the associated device that processes thesignal from the transducer; this device records bioacoustic phenomena from a transducer placed within the heart, blood vessels, or body cavities.

Official code: E.1280. Product type: Steerable catheter. Official classification: Class 2. A steerable catheter is a catheter used for diagnostic and monitoring purposes whose movements are directed by a steering control unit.

Official code: E.1290. Product type: Steerable catheter control system. Official classification: Class 2. A steerable catheter control system is a device that is connected to the proximal end of a steerable guide wire that controlsthe motion of the steerable catheter.

Official code: E.1300. Product type: Catheter cannula. Official classification: Class 2. A catheter cannula is a hollow tube which is inserted into a vessel or cavity; this device provides a rigid or semirigid structure which can be connected to a tube or connector.

Official code: E.1310. Product type: Vessel dilator for percutaneous catheterization. Official classification: Class 2. A vessel dilator for percutaneous catheterization is a device which is placed over the guide wire to enlarge the opening in the vessel, and which is then removed before sliding the catheter over the guide wire.

Official code: E.1330. Product type: Catheter guide wire. Official classification: Class 2. A catheter guide wire is a coiled wire that is designed to fit inside a percutaneous catheter for the purpose of directing the catheter through a blood vessel.

Official code: E.1340. Product type: Catheter introducer. Official classification: Class 2. A catheter introducer is a sheath used to facilitate placing a catheter through the skin into a vein or artery.

Official code: E.1350. Product type: Catheter balloon repair kit. Official classification: Class 3. A catheter balloon repair kit is a device used to repair or replace the balloon of a balloon catheter. The kit contains the materials, such as glue and balloons, necessary to effect the repair or replacement.

Official code: E.1360. Product type: Trace microsphere. Official classification: Class 3. A trace microsphere is a radioactively tagged nonbiodegradable particle that is intended to be injected into an artery or vein and trapped in the capillary bed for the purpose of studying blood flow within or to an organ.

Official code: E.1370. Product type: Catheter tip occluder. Official classification: Class 2. A catheter tip occluder is a device that is inserted into certain catheters to prevent flow through one or more orifices.

Official code: E.1380. Product type: Catheter stylet. Official classification: Class 2. A catheter stylet is a wire that is run through a catheter or cannula to render it stiff.

Official code: E.1390. Product type: Trocar. Official classification: Class 2. A trocar is a sharp-pointed instrument used with a cannula for piercing a vessel or chamber to facilitate insertion of the cannula.

Official code: E.1415. Product type: Coronary vascular physiologic simulation software device. Official classification: Class 2. A coronary vascular physiologic simulation software device is a device that provides simulated functional assessment of blood flow in the coronary vascular system using data extracted from medical device imaging to solve algorithms and yield simulated metrics of physiologic information (e.g., blood flow, coronary flow reserve, fractional flow reserve, andmyocardial perfusion). A coronary vascular physiologic simulation software device is intended to generate results for use and review by a qualified clinician.

Official code: E.1425. Product type: Programmable diagnostic computer. Official classification: Class 2. A programmable diagnostic computer is a device that can be programmed to compute various physiologic or blood flow parameters based on the output from one or more electrodes, transducers, or measuring devices; this device includes any associated commercially supplied programs.

Official code: E.1435. Product type: Single-function preprogrammed diagnostic computer. Official classification: Class 2. A single-function, preprogrammed diagnostic computer is a hard-wired computer that calculates a specific physiological or blood- flow parameter based on information obtained from one or more electrodes, transducers, or measuring devices.

Official code: E.1450. Product type: Densitometer. Official classification: Class 2. A densitometer is a device used to measure the transmission of light through an indicator in a sample of blood.

Official code: E.1650. Product type: Angiographic injector and syringe. Official classification: Class 2. An angiographic injector and syringe is a device that consists of a syringe and a high-pressure injector which are used to inject contrast material into the heart, great vessels, and coronary arteries to study the heart and vessels by x-ray photography.

Official code: E.1660. Product type: Indicator injector. Official classification: Class 2. An indicator injector is an electrically or gas-powered device designed to inject accurately an indicator solution into the blood stream. This device may be used in conjunction with a densitometer or thermodilution device to determine cardiac output.

Official code: E.1670. Product type: Syringe actuator for an injector. Official classification: Class 2. A syringe actuator for an injector is an electrical device that controls the timing of an injection by an angiographic or indicator injector and synchronizes the injection with the electrocardiograph signal.

Official code: E.1750. Product type: External programmable pacemaker pulse generator. Official classification: Class 2. An external programmable pacemaker pulse generator is a device that can be programmed to produce one or more pulses at preselected intervals;this device is used in electrophysiological studies.

Official code: E.1800. Product type: Withdrawal-infusion pump. Official classification: Class 2. A withdrawal-infusion pump is a device designed to inject accurately drugs into the bloodstream and to withdraw blood samples for use in determining cardiac output.

Official code: E.1875. Product type: Stethoscope. Official classification: Class 1,2. (a)Manual stethoscope --(1)Identification: A manual stethoscope is a mechanical device used to project the sounds associated with the heart, arteries, and veins and other internal organs.(2)Classification: Class 1. (b)Electronic stethoscope --(1)Identification: An electronic stethoscope is an electrically amplified device used to project the sounds associated with the heart, arteries, and veins and other internal organs. (2)Classification: Class 2.

Official code: E.1915. Product type: Thermodilution probe. Official classification: Class 2. A thermodilution probe is a device that monitors cardiac output by use of thermodilution techniques; this device is commonly attached to a catheter that may have one or more probes.

Official code: E.2050. Product type: Biopotential amplifier and signal conditioner. Official classification: Class 2. A biopotential amplifier and signal conditioner is a device used to amplify or condition an electrical signal of biologic origin.

Official code: E.2060. Product type: Transducer signal amplifier and signal conditioner. Official classification: Class 2. A transducer signal amplifier and conditioner is a device used to provide the excitationenergy for the transducer and to amplify or condition the signal emitted by the transducer.

Official code: E.2100. Product type: Cardiovascular blood flowmeter. Official classification: Class 2. A cardiovascular blood flowmeter is a device that is connected to a flow transducer that energizes the transducer and processes and displays the blood flow signal.

Official code: E.2120. Product type: Extravascular blood flow probe. Official classification: Class 2. An extravascular blood flow probe is an extravascular ultrasonic or electromagnetic probe used in conjunction with a blood flowmeter to measure blood flow in a chamber or vessel.

Official code: E.2300. Product type: Cardiac monitor (including cardiotachometer and rate alarm). Official classification: Class 2. A cardiac monitor (including cardiotachometer and rate alarm) is a device used to measure the heart rate from an analog signal produced by an electrocardiograph, vectorcardiograph,or blood pressure monitor. This device may sound an alarm when the heart rate falls outside preset upper and lower limits.

Official code: E.2310. Product type: Apex cardiograph (vibrocardiograph). Official classification: Class 2. An apex cardiograph (vibrocardiograph) is a device used to amplify or condition the signal from an apex cardiographic transducer and to produce a visual display of the motion of the heart; this device also provides any excitation energy required by the transducer.

Official code: E.2320. Product type: Ballistocardiograph. Official classification: Class 2. A ballistocardiograph is a device, including a supporting structure on which the patient is placed, that moves in response to blood ejection from the heart. The device often provides a visual display.

Official code: E.2330. Product type: Echocardiograph. Official classification: Class 2. An echocardiograph is a device that uses ultrasonic energy to create images of cardiovascular structures. It includes phased arrays and two-dimensional scanners.

Official code: E.2340. Product type: Electrocardiograph. Official classification: Class 2. An electrocardiograph is a device used to process the electrical signal transmitted through two or more electrocardiograph electrodes and to produce a visual display of the electrical signal produced by the heart.

Official code: E.2350. Product type: Electrocardiograph lead switching adaptor. Official classification: Class 2. An electrocardiograph lead switching adaptor is a passive switching device to which electrocardiograph limb and chest leads may be attached. This device is used to connect various combinations of limb and chest leads to the output terminals in order to create standard lead combinations such as leads I, II, and III.

Official code: E.2360. Product type: Electrocardiograph. Official classification: Class 2. An electrocardiograph electrodeis the electrical conductor which is applied to the surface of the body to transmit the electrical electrodesignal at the body surface to a processor that produces an electrocardiogram or vectorcardiogram.

Official code: E.2390. Product type: Phonocardiograph. Official classification: Class 1. A phonocardiograph is a device used to amplify or condition the signal from a heart sound transducer. This device furnishes the excitation energy for the transducer and provides a visual or audible display of the heart sounds.

Official code: E.2400. Product type: Vectrocardiograph. Official classification: Class 2. A vectorcardiograph is a device used to process the electrical signal transmitted through electrocardiograph electrodes and to produce a visual display of the magnitude and direction of the electrical signal produced by the heart.

Official code: E.2450. Product type: Medical cathode-ray tube display. Official classification: Class 2. A medical cathode-ray tube display is a device designed primarily to display selected biological signals. This device often incorporates special display features unique to a specific biological signal.

Official code: E.2675. Product type: Oscillometer. Official classification: Class 2. An oscillometer is a device used to measure physiological oscillations of any kind, e.g., changes in the volume of arteries.

Official code: E.2700. Product type: Oximeter. Official classification: Class 2. An oximeter is a device used to transmit radiation at a known wavelength(s) through blood and to measure the blood oxygen saturation based on the amount of reflected or scattered radiation. It may be used alone or in conjunction with a fiberoptic oximeter catheter.

Official code: E.2710. Product type: Ear oximeter. Official classification: Class 2. An ear oximeter is an extravascular device used to transmit light at a known wavelength(s) through blood in the ear. The amount of reflected or scattered light as indicated by this device is used to measure the blood oxygen saturation.

Official code: E.2750. Product type: Impedance phlebograph. Official classification: Class 2. An impedance phlebograph is a device used to provide a visual display of the venous pulse or drainage by measuring electrical impedance changes in a region of the body.

Official code: E.2770. Product type: Medical Impedance plethysmograph. Official classification: Class 2. A medicalimpedance plethysmograph is a device used to estimate peripheral blood flow by measuring electrical impedance changes in a region of the body such as the arms and legs for medical purposes.

Official code: E.2780. Product type: Hydraulic, pneumatic, or photoelectric plethysmographs. Official classification: Class 2. A hydraulic, pneumatic, or photoelectric plethysmograph is a device used to estimate blood flow in a region of the body using hydraulic, pneumatic, or photoelectric measurement techniques.

Official code: E.2800. Product type: Medical magnetic tape recorder. Official classification: Class 2. A medical magnetic tape recorder is a device used to record and play back signals from, for example, physiological amplifiers, signal conditioners, or computers.

Official code: E.2840. Product type: Apex cardiograph transducer. Official classification: Class 2. An apex cardiographic transducer is a device used to detect motion of the heart (acceleration, velocity, or displacement) bychanges in the mechanical or electrical properties of the device.

Official code: E.2850. Product type: Extravascular blood pressure transducer. Official classification: Class 2. An extravascular blood pressure transducer is a device used to measure blood pressure by changes in the mechanical or electrical properties of the device. The proximal end of the transducer is connected to a pressure monitor that produces an analog or digital electrical signal related to the electrical or mechanical changes produced in the transducer.

Official code: E.2855. Product type: Implantable Intra-aneurysm Pressure Measurement System. Official classification: Class 2. Implantable intra-aneurysm pressure measurement system is a device used to measure the intra-sac pressure in a vascular aneurysm. The device consists of a pressure transducer that is implanted into the aneurysm and a monitor that reads the pressure from the transducer.

Official code: E.2860. Product type: Heart sound transducer. Official classification: Class 2. A heart sound transducer is an external transducer that exhibits a change in mechanical or electrical properties in relation to sounds produced by the heart. This device may be used in conjunction with a phonocardiograph to record heart sounds.

Official code: E.2870. Product type: Catheter tip pressure transducer. Official classification: Class 2. A catheter tip pressure transducer is a device incorporated into the distal end of a catheter. When placed in the bloodstream, its mechanical or electrical properties change in relation to changes in blood pressure. These changes are transmitted to accessory equipment for processing.

Official code: E.2880. Product type: Ultrasonic transducer. Official classification: Class 2. An ultrasonic transducer is a device applied to the skin to transmit and receive ultrasonic energy that is used in conjunction with an echocardiograph to provide imaging of cardiovascular structures. This device includes phased arrays and two-dimensional scanning transducers.

Official code: E.2890. Product type: Vessel occlusion transducer. Official classification: Class 2. A vessel occlusion transducer is a device used to provide an electrical signal corresponding to sounds produced in a partially occluded vessel. This device includes motion, sound, and ultrasonic transducers.

Official code: E.2900. Product type: Patient transducer and electrode cable (including connector). Official classification: Class 2. A patient transducer and electrode cable (including connector) is an electrical conductor used to transmit signals from, or power or excitation signals to, patient-connected electrodes or transducers.

Official code: E.2910. Product type: Radiofrequency physiological signal transmitter and receiver. Official classification: Class 2. A radiofrequency physiological signal transmitter and receiver is a device used to condition a physiological signal so that it can be transmitted via radiofrequency from one location to another, e.g.,a central monitoring station. The received signal is reconditioned by the device into its original format so that it can be displayed.

Official code: E.2920. Product type: Telephone electrocardiograph transmitter and receiver. Official classification: Class 2. A telephone electrocardiograph transmitter and receiver is a device used to condition an electrocardiograph signal so that itcan be transmitted via a telephone line to another location. This device also includesa receiver that reconditions the received signal into its original format so that it can be displayed. The device includes devices used to transmit and receive pacemaker signals.

Official code: E.3250. Product type: Vascular clip. Official classification: Class 2. A vascular clip is an implanted extravascular devicedesigned to occlude, by compression, blood flow in small blood vessels other than intracranial vessels.

Official code: E.3260. Product type: Vena cava clip. Official classification: Class 2. A vena cava clip is an implanted extravascular device designed to occlude partially the vena cava for the purpose of inhibiting the flow of thromboembolic through that vessel.

Official code: E.3300. Product type: Arterial embolization device. Official classification: Class 3. An arterial embolization device is an intravascular device used to control internal bleeding or to stop the flow of blood from an artery to certain abdominal tumors (e.g.,renal tumors, hepatomas) and malformed arteries. This device is not intended for internal arteries of the brain.

Official code: E.3375. Product type: Cardiovascular intravascular filter. Official classification: Class 2. A cardiovascular intravascular filter is an implant that is placed in the inferior vena cava for the purpose of preventing pulmonary thromboembolism(blood clots generated in the lower limbs and broken loose into the blood stream) from flowing into the right side of the heart and the pulmonary circulation.

Official code: E.3450. Product type: Vascular graft prosthesis. Official classification: Class 2. A vascular graft prosthesis is an implanted device intended to repair, replace, or bypass sections of native or artificial vessels, excluding coronary or cerebral vasculature, and to provide vascular access. It is commonly constructed of materials such as polyethylene terephthalate and polytetrafluoroethylene, and it may be coated with a biological coating, such as albumin or collagen, or a synthetic coating, such as silicone. The graft structure itself is not made of materials of animal origin, including human umbilical cords.

Official code: E.3460. Product type: Endovascular suturing system. Official classification: Class 2. An endovascular suturing system is a medical device intended to provide fixation and sealing between an endovascular graft and the native artery. The system is comprised of the implant device and anendovascular delivery device used to implant the endovascular suture.

Official code: E.3470. Product type: Intracardiac patch or pledget made of polypropylene, polyethylene terephthalate, or polytetrafluoroethylene. Official classification: Class 2. An intracardiac patch or pledget made of polypropylene, polyethylene terephthalate, or polytetrafluoroethylene is a fabric device placed in the heart that is used to repair septal defects, for patch grafting, to repair tissue, and to buttress sutures.

Official code: E.3535. Product type: Intra-aortic balloon and control system. Official classification: Class 2,3. (a) Identification: An intra-aortic balloon and control system is a device that consists of an inflatable balloon, which is placed in the aorta to improve cardiovascular functioning during certain life-threatening emergencies, and a control system for regulating the inflation and deflation of the balloon. The control system, which monitors and is synchronized with the electrocardiogram, provides a means for setting the inflation and deflation of the balloon with the cardiac cycle. (b) Classification: (1) Class 2: The device is indicated for acute coronary syndrome, cardiac and non-cardiac surgery, or complications of heart failure. (2) Class 3: The device is indicated for septic shock and pulsatile flow generation.

Official code: E.3545. Product type: Ventricular bypass (assist) device. Official classification: Class 3. A ventricular bypass (assist) device is a device that assists the left or right ventricle in maintaining circulatory blood flow. The device is either totally or partially implanted in the body.

Official code: E.3600. Product type: External pacemaker pulse generator. Official classification: Class 3. An external pacemaker pulse generator is a device that has a power supply and electronic circuits that produce a periodic electrical pulse to stimulate the heart. This device, which is used outside the body, is used as a temporary substitute for the heart'sintrinsic pacing system until apermanent pacemaker can be implanted, or to control irregular heartbeats in patients following cardiac surgery or a myocardial infarction. The device may have adjustments for impulse strength, duration, R-wave sensitivity, and other pacing variables.

Official code: E.3610. Product type: Implantable pacemaker pulse generator. Official classification: Class 3. An implantable pacemaker pulse generator is a device that has a power supply and electronic circuits that produce a periodic electrical pulse to stimulate the heart. This device is used as a substitute for the heart's intrinsic pacing system to correct both intermittent and continuous cardiac rhythm disorders. This device includes triggered, inhibited, and asynchronous devices implanted in the human body.

Official code: E.3620. Product type: Pacemaker lead adaptor. Official classification: Class 2. A pacemaker lead adaptor is a device used to adapt a pacemaker lead so that it can be connected to a pacemaker pulse generator produced by a different manufacturer.

Official code: E.3630. Product type: Pacemaker generator. Official classification: Class 2. A pacemaker generator function analyzer is a device that is connectedto a pacemaker pulse generator to test any or all of the function analyzergenerator's parameters, including pulse duration, pulse amplitude, pulse rate, and sensing threshold.

Official code: E.3650. Product type: Pacemaker polymeric mesh bag. Official classification: Class 1. A pacemaker polymeric mesh bag is an implanted device used to hold a pacemaker pulse generator. The bag is designed to create a stable implant environment for the pulse generator.

Official code: E.3670. Product type: Pacemaker charger. Official classification: Class 1. A pacemaker charger is a device used transcutaneously to recharge the batteries of a rechargeable pacemaker.

Official code: E.3680. Product type: Cardiovascular permanent or temporary pacemaker electrode. Official classification: Class 2,3. (a)Temporary pacemaker electrode --(1)Identification: A temporary pacemaker electrode is a device consisting of flexible insulated electrical conductors with one end connected to an external pacemaker pulse generator and the other end applied to the heart. The device is used to transmit a pacing electrical stimulus from the pulse generator to the heart and/or to transmit the electrical signal of the heart to the pulse generator. (2) Classification: Class 2. (b)Permanent pacemaker electrode --(1)Identification: A permanent pacemaker electrode is a device consisting of flexible insulated electrical conductors with one end connected to an implantable pacemaker pulse generator and the other end applied to the heart. The device is used to transmit a pacing electrical stimulus from the pulse generator to the heart and/or to transmit the electrical signal of the heart to the pulse generator. (2) Classification: Class 3.

Official code: E.3690. Product type: Pacemaker test magnet. Official classification: Class 1. A pacemaker test magnet is a device used to test an inhibited or triggered type of pacemaker pulse generator and cause an inhibited or triggered generator to revert to asynchronous operation.

Official code: E.3700. Product type: Pacemaker programmers. Official classification: Class 3. A pacemaker programmer isa device used to change noninvasively one or more of the electrical operating characteristics of a pacemaker.

Official code: E.3710. Product type: Pacemaker repair or replacement material. Official classification: Class 3. A pacemaker repair or replacement material is an adhesive, a sealant, a screw, a crimp, or anyother material used to repair a pacemaker lead or to reconnect a pacemaker lead to a pacemaker pulse generator.

Official code: E.3720. Product type: Pacemaker electrode function tester. Official classification: Class 2. A pacemaker electrode function tester is a device which is connected to an implanted pacemaker lead that supplies an accurately calibrated, variable pacing pulse for measuring the patient's pacing threshold and intracardiac R-wave potential.

Official code: E.3730. Product type: Pacemaker service tools. Official classification: Class 1. Pacemaker service tools are devices such as screwdrivers and Allen wrenches, used to repair a pacemaker lead or to reconnect a pacemaker lead to a pacemaker generator.

Official code: E.3800. Product type: Annuloplasty ring. Official classification: Class 2. An annuloplasty ring is a rigid or flexible ring implanted around the mitral or tricuspid heart valve for reconstructive treatment of valvular insufficiency.

Official code: E.3850. Product type: Carotid sinus nerve stimulator. Official classification: Class 3. A carotid sinus nerve stimulator is an implantable device used to decrease arterial pressure by stimulating Hering's nerve atthe carotid sinus.

Official code: E.3925. Product type: Replacement heart valve. Official classification: Class 3. A replacement heart valve is a device intended to perform the function of any of the heart's natural valves. This device includes valves constructed of prosthetic materials, biologic valves (e.g.,porcine valves), or valves constructed of a combination of prosthetic and biologic materials.

Official code: E.3935. Product type: Prosthetic heart valve holder. Official classification: Class 1. A prosthetic heart valve holder is a device used to hold a replacement heart valve while it is being sutured into place.

Official code: E.3945. Product type: Prosthetic heart valve sizer. Official classification: Class 1. A prosthetic heart valve sizer is a device used to measure the size of the natural valve opening to determine the size of the appropriate replacement heart valve.

Official code: E.4075. Product type: Endomyocardial biopsy device. Official classification: Class 2. An endomyocardial biopsy device is a device used in a catheterization procedure to remove samples of tissue from the inner wall of the heart.

Official code: E.4100. Product type: Extracorporeal circuit and accessories for long-term respiratory/cardiopulmonary failure. Official classification: Class 2. An extracorporeal circuit and accessories for long-term respiratory/cardiopulmonary support (> 6 hours) isa system of devices and accessories that provides assisted extracorporeal circulation and physiologic gas exchange of the patient's blood in patients with acute respiratory failure or acute cardiopulmonary failure, where other available treatment optionshave failed, and continued clinical deterioration is expected or the risk of death is imminent. The main devices and accessories of the system include,but are not limited to, the console (hardware), software, and disposables, including, but not limited to, an oxygenator, blood pump, heat exchanger, cannula, tubing, filters, and other accessories (e.g., monitors, detectors, sensors, connectors, etc.).

Official code: E.4200. Product type: Cardiopulmonary bypass accessory equipment. Official classification: Class 1,2. Cardiopulmonary bypass accessory equipment is a device that has no contact with blood and that is used in the cardiopulmonary bypass circuit to support, adjoin, or connect components, or to aid in the setup of the extracorporeal line, e.g.,an oxygenator mounting bracket or system-priming equipment. Classification:(1)Class 1 devices do not involve an electrical connection to the patient.;(2) Class 2 devices involve an electrical connection to the patient.

Official code: E.4205. Product type: Cardiopulmonary bypass bubble detector. Official classification: Class 2. A cardiopulmonary bypass bubble detector is a deviceused to detect bubbles in the arterial return line of the cardiopulmonary bypass circuit.

Official code: E.4210. Product type: Cardiopulmonary bypass vascular catheter, cannula, or tubing. Official classification: Class 2. A cardiopulmonary bypass vascular catheter, cannula, or tubing is a device used in cardiopulmonary surgery to cannulate the vessels, perfuse the coronary arteries, and to interconnect the catheters and cannulas with an oxygenator. The device includes accessory bypass equipment.

Official code: E.4220. Product type: Cardiopulmonary bypass heart-lung machine console. Official classification: Class 2. A cardiopulmonary bypass heart-lung machine console is a device that consists of a control panel and the electrical power and control circuitry for a heart-lung machine. The console is designed to interface with the basic units used in a gas exchange system, including the pumps, oxygenator, and heat exchanger.

Official code: E.4230. Product type: Cardiopulmonary bypass defoamer. Official classification: Class 2. A cardiopulmonary bypass defoamer is a device used in conjunction with an oxygenator during cardiopulmonary bypass surgery to remove gas bubbles from the blood.

Official code: E.4240. Product type: Cardiopulmonary bypass heat exchanger. Official classification: Class 2. A cardiopulmonary bypass heat exchanger is a device, consisting of a heat exchange system used in extracorporeal circulationto warm or cool the blood or perfusion fluid flowing through the device.

Official code: E.4250. Product type: Cardiopulmonary bypass temperature controller. Official classification: Class 2. A cardiopulmonary bypass temperature controller is a device used to control the temperature of the fluid entering and leavinga heat exchanger.

Official code: E.4260. Product type: Cardiopulmonary bypass arterial line blood filter. Official classification: Class 2. A cardiopulmonary bypass arterial line blood filter is a device used as part of a gas exchange (oxygenator) system to filter nonbiologic particles and emboli (blood clots or pieces of foreign material flowing in the bloodstream which will obstruct circulation by blocking a vessel) out of the blood. It is used in the arterial return line.

Official code: E.4270. Product type: Cardiopulmonary bypass cardiotomy suction line blood filter. Official classification: Class 2. A cardiopulmonary bypass cardiotomy suction line blood filter is a device used as part of a gas exchange (oxygenator)system to filter nonbiologic particles and emboli (a blood clot or a piece of foreign material flowing in the bloodstream which will obstruct circulation by blocking a vessel) out of the blood. This device is intended for use in the cardiotomy suction line.

Official code: E.4280. Product type: Cardiopulmonary prebypass filter. Official classification: Class 2. A cardiopulmonary prebypass filter is a device used during priming of the oxygenator circuit to remove particulates or otherdebris from the circuit prior to initiating bypass. The device is not used to filter blood.

Official code: E.4290. Product type: Cardiopulmonary bypass adaptor, stopcock, manifold, or fitting. Official classification: Class 2. A cardiopulmonary bypass adaptor, stopcock, manifold, or fitting is a device used in cardiovascular diagnostic, surgical, and therapeutic applications to interconnect tubing, catheters, or other devices.

Official code: E.4300. Product type: Cardiopulmonary bypass gas control unit. Official classification: Class 2. A cardiopulmonary bypass gas control unit is a device used to control and measure the flow of gas into the oxygenator. The device is calibrated for a specific gas.

Official code: E.4310. Product type: Cardiopulmonary bypass coronary pressure gauge. Official classification: Class 2. A cardiopulmonary bypass coronary pressure gauge is a device used in cardiopulmonary bypass surgery to measure the pressure of the blood perfusing the coronary arteries.

Official code: E.4320. Product type: Cardiopulmonary bypass pulsatile flow generator. Official classification: Class 3. A cardiopulmonary bypass pulsatile flow generator is an electrically and pneumatically operated device used to create pulsatile blood flow. The device is placed in a cardiopulmonary bypass circuit downstream from the oxygenator.

Official code: E.4330. Product type: Cardiopulmonary bypass on-line blood gas monitor. Official classification: Class 2. A cardiopulmonary bypass on-line blood gas monitor is a device used in conjunction with a blood gas sensor to measure the level of gases in the blood.

Official code: E.4340. Product type: Cardiopulmonary bypass level sensing monitor and/or control. Official classification: Class 2. A cardiopulmonary bypass level sensing monitor and/or control is a device used to monitor and/or control the level of blood in the blood reservoir and to sound an alarm when the level falls below a predetermined value.

Official code: E.4350. Product type: Cardiopulmonary bypass oxygenator. Official classification: Class 2. A cardiopulmonary bypass oxygenator is a device used to exchange gases between blood and a gaseous environment to satisfy the gas exchange needs of a patient during open-heart surgery.

Official code: E.4360. Product type: Nonroller-type cardiopulmonary bypass blood pump. Official classification: Class 3. A nonroller-type cardiopulmonary bypass blood pump is a device that uses a method other than revolving rollers to pump the blood through the cardiopulmonary bypass circuit during bypass surgery.

Official code: E.4370. Product type: Roller-type cardiopulmonary bypass blood pump. Official classification: Class 2. A roller-type cardiopulmonary bypass blood pump is a device that uses a revolving roller mechanism to pump the blood through the cardiopulmonary bypass circuit during bypass surgery.

Official code: E.4380. Product type: Cardiopulmonary bypass pump speed control. Official classification: Class 2. A cardiopulmonary bypass pump speed control is a device used that incorporates an electrical system or a mechanical system, or both, and is used to control the speed of blood pumps used in cardiopulmonary bypass surgery.

Official code: E.4390. Product type: Cardiopulmonary bypass. Official classification: Class 2. A cardiopulmonary bypass pump tubing is polymeric tubing which is used in the blood pump head and which is cyclically pump tubingcompressed by the pump to cause the blood to flow through the cardiopulmonary bypass circuit.

Official code: E.4400. Product type: Cardiopulmonary bypass blood reservoir. Official classification: Class 2. A cardiopulmonary bypass blood reservoir is a device used in conjunction with short-term extracorporeal circulation devices to hold a reserve supply of blood in the bypass circulation.

Official code: E.4410. Product type: Cardiopulmonary bypass in- line blood gas sensor. Official classification: Class 2. A cardiopulmonary bypass in-line blood gas sensor is a transducer that measures the level of gases in the blood.

Official code: E.4420. Product type: Cardiopulmonary bypass cardiotomy return sucker. Official classification: Class 2. A cardiopulmonary bypass cardiotomy return sucker is a device that consists of tubing, a connector, and a probe or tip that is used to remove blood from the chest or heart during cardiopulmonary bypass surgery.

Official code: E.4430. Product type: Cardiopulmonary bypass intracardiac suction control. Official classification: Class 2. A cardiopulmonary bypass intracardiac suction control is a device which provides thevacuum and control for a cardiotomy return sucker.

Official code: E.4450. Product type: Vascular clamp. Official classification: Class 2. A vascular clamp is a surgical instrument used to occlude a blood vessel temporarily.

Official code: E.4475. Product type: Surgical vessel dilator. Official classification: Class 2. A surgical vessel dilator is a device used to enlarge or calibrate a vessel.

Official code: E.4500. Product type: Cardiovascular surgical instruments. Official classification: Class 1. Cardiovascular surgical instruments are surgical instruments that have special features for use in cardiovascular surgery. These devices include, e.g., forceps, retractors, and scissors.

Official code: E.4510. Product type: Apical closure device. Official classification: Class 2. An apical closure device is a device consisting of a delivery system and implant component that is used for soft tissue approximation of cardiac apical tissue during transcatheter valve replacement procedures.

Official code: E.4875. Product type: Intraluminal artery stripper. Official classification: Class 2. An intraluminal artery stripper is a device used to perform an endarterectomy (removal of plaque deposits from arteriosclerotic arteries.)

Official code: E.4885. Product type: External vein stripper. Official classification: Class 2. An external vein stripper is an extravascular device used to remove a section of a vein.

Official code: E.5050. Product type: Patient care suction apparatus. Official classification: Class 2. A patient care suction apparatus is a device used with an intrathoracic catheter to withdraw fluid from the chest during therecovery period following surgery.

Official code: E.5150. Product type: Embolectomy catheter. Official classification: Class 2. An embolectomy catheter is a balloon-tipped catheter that is used to remove thromboembolic, i.e., blood clots which have migrated in blood vessels from one site in the vascular tree to another.

Official code: E.5175. Product type: Septostomy catheter. Official classification: Class 2. A septostomy catheter is a special balloon catheter that is used to create or enlarge the atrial septal defect found in the heart of certain infants.

Official code: E.5200. Product type: External cardiac compressor. Official classification: Class 3. An external cardiac compressor is an external device that is electrically, pneumatically, or manually powered and is used to compress the chest periodically in the region of the heart to provide blood flow during cardiac arrest.

Official code: E.5210. Product type: CPR aid1,. Official classification: Class 2. (a)A CPR aid without feedback is a device that performs a simple function such as proper hand placement and/or simple prompting for rate and/or timing of compressions/breathing for the professionally trained rescuer, but offers no feedback related to the quality of the CPR being provided. These devices are intended for use by persons professionally trained in CPR to assure proper use and the delivery of optimal CPR to the victim. Classification: Class 1. (b)A CPR Aid device with feedback is a device that provides real-time feedback to the rescuer regarding the quality of CPR being delivered to the victim, and provides either audio and/or visual information to encourage the rescuer to continue the consistent application of effective manual CPR in accordance with current accepted CPR guidelines (to include, but not be limited to, parameters such as compression rate, compression depth, ventilation, recoil, instruction for one or multiple rescuers, etc.). These devices may also perform a coaching function to aid rescuers in the sequence of steps necessary to perform effective CPR on a victim. Classification: Class 2.

Official code: E.5225. Product type: External counter-pulsating device. Official classification: Class 2,3. (a)Identification: An external counter-pulsating device is a noninvasive device used to assist the heart by applying positive or negative pressure to one or more of the body's limbs in synchrony with the heart cycle. (b)Classification: (1) Class 2: The device is for the treatment of chronic stable angina. (2) Class 3: Those that do not fit the description listed in Class 2.

Official code: E.5300. Product type: DC-defibrillator(including paddles). Official classification: Class 2,3. (a)Low-energy DC-defibrillator (1)Identification: A low-energy DC-defibrillator is a device that delivers into a 50 ohm test load an electrical shock of a maximum of 360 joules of energy used for defibrillating (restoring normal heart rhythm) the atria or ventricles of the heart or to terminate other cardiacarrhythmias. This generic type of device includes low energy defibrillators with a maximum electrical output of less than 360 joules of energy that are used in pediatric defibrillation or in cardiac surgery. The device may either synchronize the shock with the proper phase of the electrocardiogram or may operate asynchronously. The device delivers the electrical shock through paddles placed either directly across the heart or on the surface of the body. (2)Classification: Class 2. (b)High-energy DC-defibrillator (1)Identification: A high-energy DC-defibrillator is a device that delivers into a 50 ohm test load an electrical shock of greater than 360 joules of energy used for defibrillating the atria or ventricles of the heart or to terminate other cardiac arrhythmias. The device may either synchronize the shock with the proper phase of the electrocardiogram or may operate asynchronously. The device delivers the electrical shock through paddles placed either directly across the heart or on the surface of the body. (2)Classification: Class 3.

Official code: E.5310. Product type: Automated external defibrillator system. Official classification: Class 3. An automated external defibrillator (AED) system consists of an AED and those accessories necessary for the AED to detect and interpret an electrocardiogram and deliver an electrical shock (e.g.,battery, pad electrode, adapter, and hardware key for pediatric use). An AED system analyzes the patient's electrocardiogram, interprets the cardiac rhythm, and automatically delivers an electrical shock (fully automated AED), or advises the user to deliver the shock (semi-automated or shock advisory AED) to treat ventricular fibrillation or pulseless ventricular tachycardia.

Official code: E.5325. Product type: Defibrillator tester. Official classification: Class 2. A defibrillator tester is a device that is connected to the output of a defibrillator and is used to measure the energy delivered by the defibrillator into a standard resistive load. Some testers also provide waveform information.

Official code: E.5550. Product type: External transcutaneous cardiac. Official classification: Class 2. An external transcutaneous cardiac pacemaker (noninvasive) is a device used to supply a periodic electrical pulse intended to pace the heart. The pulse from the device is usually applied to the surface of the chest through electrodes such as defibrillator paddles. pacemaker(noninvasive)

Official code: E.5700. Product type: Steerable cardiac ablation catheter remote control system. Official classification: Class 2. A steerable cardiac ablation catheter remote control system is a device that is external to the body and interacts with the manual handle of a steerable cardiac ablation catheter to remotely control the advancement, retraction, rotation, and deflection of a compatible, steerable ablation catheter used for the treatment of cardiac arrhythmias in the right side of the heart. The device allows reversion to manual control of the steerable cardiac ablation catheter without withdrawal of the catheter and interruption of the procedure.

Official code: E.5800. Product type: Compressible limb sleeve. Official classification: Class 2. A compressible limb sleeve is a device that is used to prevent pooling of blood in a limb by inflating periodically a sleevearound the limb.

Official code: E.5900. Product type: Thermal regulating system. Official classification: Class 2. A thermal regulating system is an external system consisting of a device that is placed in contact with the patient and a temperature controller for the device. The system is used to regulate patient temperature.

Official code: E.5910. Product type: Esophageal thermal regulation device. Official classification: Class 2. An esophageal thermal regulation device is a device used to apply a specified temperature to the endoluminal surface of the esophagus via an external controller. This device may incorporate a mechanism for gastric decompression and suctioning. The device is used to regulate patient temperature.

Official code: E.5925. Product type: Automatic rotating tourniquet. Official classification: Class 2. An automatic rotating tourniquet is a device that prevents blood flow in one limb at a time, which temporarily reduces the total blood volume, thereby reducing the normal workload of the heart.

Official code: E.9999. Product type: Others(Cardiovascular Devices) 1,. Official classification: Class 2,3. The products excluded from the above-classification are adopted in this classification and specified by the central competent health authority.

Official code: F.0001. Product type: Retraction cord. Official classification: Class 1,2. Retraction cord inserted in gums (gingiva) is used to extend the space between teeth and gums. Classification:(1) Retractioncord contains medicine is class 2. (2) Others are class 1.

Official code: F.0002. Product type: Orthodontic planning software. Official classification: Class 2. Orthodontic Planning Software is a software that is to be used for the diagnosis and treatment planning of orthodontic patients

Official code: F.1500. Product type: Gingival fluid measurer. Official classification: Class 1. A gingival fluid measurer is a gauge device intended to measure the amount of fluid in the gingival sulcus (depression between the tooth and gums) to determine if there is a gingivitis condition.

Official code: F.1720. Product type: Pulp tester. Official classification: Class 2. A pulp tester is an AC or battery powered device intended to evaluate the pulpal vitality of teeth by employing high frequency current transmitted by an electrode to stimulate the nerve tissue in the dental pulp.

Official code: F.1730. Product type: Electrode gel for pulp tester. Official classification: Class 1. An electrode gel for pulp testers is a device intended to be applied to the surface of a tooth before use of a pulp tester toaid conduction of electrical current.

Official code: F.1740. Product type: Caries detection device. Official classification: Class 2. The caries detection device is a device intended to show the existence of decay in a patient's tooth by use of electrical current.

Official code: F.1745. Product type: Laser fluorescence caries detection device. Official classification: Class 2. A laser fluorescence caries detection device is a laser, a fluorescence detector housed in a dental handpiece, and a control console that performs device calibration, as well as variable tone emitting and fluorescence measurement functions. The intended useof the device is to aid in the detection of tooth decay by measuring increased laser induced fluorescence.

Official code: F.1800. Product type: Extraoral source x-ray system. Official classification: Class 2. An extraoral source x-ray system is an AC-powered device that produces x-rays and is intended for dental radiographic examination and diagnosis of diseases of the teeth, jaw, and oral structures. The x-ray source (a tube) is located outside the mouth. This generic type of device may include patient and equipment supports and component parts.

Official code: F.1810. Product type: Intraoral source x-ray system. Official classification: Class 2. An intraoral source x-ray system is an electrically powered device that produces x-rays and is intended for dental radiographic examination and diagnosis of diseases of the teeth, jaw, and oral structures. The x-ray source (a tube) is located inside the mouth. This generic type of device may include patient and equipment supports and component parts.

Official code: F.1820. Product type: Dental x-ray exposure alignment device. Official classification: Class 1. A dental x-ray exposure alignment device is a device intended to position x-ray film and to align the examination site with the x- ray beam.

Official code: F.1830. Product type: Cephalometer. Official classification: Class 2. A cephalometer is a device used in dentistry during x-ray procedures. The device is intended to place and to hold a patient's head in a standard position during dental x-rays.

Official code: F.1840. Product type: Dental x-ray position indicating device. Official classification: Class 1. A dental x-ray position indicating device is a device, such as a collimator, cone, or aperture, that is used in dental radiographic examination. The device is intended to align the examination site with the x-ray beam and to restrict the dimensions of the dental x-ray field by limiting the size of the primary x-ray beam.

Official code: F.1850. Product type: Lead-lined position indicator. Official classification: Class 1. A lead-lined position indicator is a cone-shaped device lined with lead that is attached to a dental x-ray tube and intended to aid in positioning the tube, to prevent the misfocusing of the x-rays by absorbing divergent radiation, and to prevent leakage of radiation.

Official code: F.1870. Product type: Sulfide detection device. Official classification: Class 2. A sulfide detection device is a device consisting of an AC-powered control unit, probe handle, probe tips, cables, and accessories. This device is intended to be used in vivo, to manually measure periodontal pocket probing depths, detect the presence or absence of bleeding on probing, and detect the presence of sulfides in periodontal pockets, as an adjunct in the diagnosis of periodontal diseases in adult patients.

Official code: F.2050. Product type: Dental sonography device. Official classification: Class 1,2. (1)Dental sonography device for monitoring is an electrically powered device, intended to be used to monitor temporomandibular joint sounds. The device detects and records sounds made by the temporomandibular joint. Classification: Class 1. (2)Dental sonography device for interpretation and diagnosis is an electrically powered device, intended to interpret temporomandibular joint sounds for the diagnosis of temporomandibular joint disorders and associated orofacial pain. The device detects, records, displays, and stores sounds made by the temporomandibular joint during jaw movement. The device interprets these sounds to generate meaningful output, either directly or by connection to a personal computer. The device may be part of a system of devices, contributing joint sound information to be considered with data from other diagnostic components. Classification: Class 2.

Official code: F.2060. Product type: Jaw tracking device. Official classification: Class 1,2. (a)Jawtracking device for monitoring mandibular jaw positions relative to the maxilla (1)Identification: A jaw tracking device for monitoring mandibular jaw positions relative to the maxilla is a nonpowered or electrically powered device that measures and records anatomical distances and angles in three dimensional space, to determine the relative position of the mandible with respect to the location and position of the maxilla, while at rest and during jaw movement.(2)Classification: Class 1.(b)Jaw tracking device for interpretation of mandibular jaw positions for the diagnosis (1)Identification. A jaw tracking device for interpretationof mandibular jaw positions relative to the maxilla for the diagnosis of temporomandibular joint disorders and associated orofacial pain is a nonpowered or electrically powered device that measures and records anatomical distances and angles to determine the relative position of the mandible in three-dimensional space, with respect to the location and position of the maxilla, while at rest and during jaw movement. The device records, displays, and stores information about jaw position. The device interprets jaw position to generate meaningful output, either directly or by connection to a personal computer. The device may be a partof a system of devices, contributing jaw position information to be considered with data from other diagnostic components. (2) Classification: Class 2.

Official code: F.3060. Product type: Gold based alloys and precious metal alloys for clinical use. Official classification: Class 2. A noble metal alloy is a device composed primarily of noble metals, such as gold, palladium, platinum, or silver, that is intended for use in the fabrication of cast or porcelain-fused-to-metal crown and bridge restorations.

Official code: F.3070. Product type: Dental amalgam, mercury, and amalgam alloy. Official classification: Class 2. Dental amalgam is a device that consists of a combination of elemental mercury, supplied as a liquid in bulk, sachet, or predosed capsule form, and amalgam alloy composed primarily of silver, tin, and copper, supplied as a powder in bulk, tablet, or predosed capsuleform, for the direct filling of carious lesions or structural defects in teeth. This device also includes the individual component devices, mercury and amalgam alloy, when intended to be combined with each other to form dental amalgam.

Official code: F.3080. Product type: Mercury and alloy dispenser. Official classification: Class 1. A mercury and alloy dispenser is a device with a spring-activated valve intended to measure and dispense into a mixing capsule a predetermined amount of dental mercury in droplet form and a premeasured amount of alloy pellets.

Official code: F.3100. Product type: Dental amalgamator. Official classification: Class 1. A dental amalgamator is a device, usually AC-powered, intended to mix, by shaking, amalgam capsules containing mercury and dental alloy particles, such as silver, tin, zinc, and copper. The mixed dental amalgam material is intended for filling dental caries.

Official code: F.3110. Product type: Dental amalgam capsule. Official classification: Class 1. A dental amalgam capsule is a container device in which silver alloy is intended to be mixed with mercury to form dental amalgam.

Official code: F.3130. Product type: Preformed anchor. Official classification: Class 1. A preformed anchor is a device made of austenitic alloys or alloys containing 75 percent or greater gold or metals of the platinum group intended to be incorporated into a dental appliance, such as a denture, to help stabilize the appliance in the patient's mouth.

Official code: F.3140. Product type: Resin applicator. Official classification: Class 1. A resin applicator is a brushlike device intended for use in spreading dental resin on a tooth during application of tooth shade material.

Official code: F.3165. Product type: Precision attachment. Official classification: Class 1. A precision attachment or preformed bar is a device made of austenitic alloys or alloys containing 75 percent or greater gold and metals of the platinum group intended for use in prosthetic dentistry in conjunction with removable partial dentures. Variousforms of the device are intended to connect a lower partial denture with another lower partialdenture, to connect an upper partial denture with another upper partial denture, to connect either an upper or lower partial denture to a tooth or a crown, or to connecta fixed bridge to a partial denture.

Official code: F.3200. Product type: Resin tooth bonding agent. Official classification: Class 2. A resin tooth bonding agent is a device material, such as methylmethacrylate, intended to be painted on the interior of a prepared cavity of a tooth to improve retention of a restoration, such as a filling.

Official code: F.3220. Product type: Facebow. Official classification: Class 1. A facebow is a device intended for use indenture fabrication to determine the spatial relationship between the upper and lower jaws. This determination is intended for use in placing denture casts accurately into an articulator and thereby aiding correct placement of artificial teeth into a denture base.

Official code: F.3240. Product type: Dental bur. Official classification: Class 1. A dental bur is a rotary cutting device made from carbon steel or tungsten carbide intended to cut hard structures in the mouth, such as teeth or bone. It is also intended to cut hard metals, plastics, porcelains, and similarmaterials intended for use in the fabrication of dental devices.

Official code: F.3250. Product type: Calcium hydroxide cavity liner. Official classification: Class 2. A calcium hydroxide cavity liner is a device material intended to be applied to the interior of a prepared cavity before insertion of restorative material, e.g., amalgam etc., to protect the pulp of a tooth.

Official code: F.3260. Product type: Cavity varnish. Official classification: Class 2. Cavity varnish is a device that consists of a compound intended to coat a prepared cavity of a tooth before insertion of restorative materials. The device is intended to prevent penetration of restorative materials, e.g., amalgam etc., into the dentinal tissue.

Official code: F.3275. Product type: Dental cement. Official classification: Class 1,2. Dental cement is a device intended to serve as a temporary tooth filling or as a base cement to affix a temporary tooth filling, to affix dental devices such as crowns or bridges, or to be applied to a tooth to protect the tooth pulp. This device is made by zinc oxide-eugenol. Classification: (1)Class 1: The main component is Zinc oxide-eugenol;(2)Class 2: The main component is Dental cement other than zinc oxide-eugenol.

Official code: F.3285. Product type: Preformed clasp. Official classification: Class 1. A preformed clasp or a preformed wire clasp is a prefabricated device made of austenitic alloys or alloys containing 75 percent or greater gold and metals of the platinum group intended to be incorporated into a dental appliance, such as a partial denture, to help stabilize the appliance in the patient's mouth by fastening the appliance to an adjacent tooth.

Official code: F.3300. Product type: Hydrophilic resin coating for dentures. Official classification: Class 2. A hydrophilic resin coating for dentures is a device that consists of a water-retaining polymer that is intended to be applied to the base of a denture before the denture is inserted into the patient's mouth to improve denture retention and comfort.

Official code: F.3310. Product type: Coating material for resin fillings. Official classification: Class 2. A coating material for resin fillings is a device intended to be applied to the surface of a restorative resin dental filling to attain a smooth, glaze-like finish on the surface of the filling.

Official code: F.3330. Product type: Preformed crown. Official classification: Class 1. A preformed crown is a prefabricated device made of plastic or austenitic alloys or alloys containing 75 percent or greater gold and metals of the platinum group intended to be affixed temporarily to a tooth after removal of, or breakage of, the naturalcrown (that portion of the tooth that normally protrudes above the gums). It is intended for use as a functional restoration until a permanent crown is constructed. The device also may be intended for use as a functional restoration for a badly decayed deciduous (baby) tooth until the adult tooth erupts.

Official code: F.3350. Product type: Gold or stainless steel cusp. Official classification: Class 1. A gold or stainless steel cusp is a prefabricated device made of austenitic alloys or alloys containing 75 percent or greatergold and metals of the platinum group or stainless steel intended to provide a permanent cusp (a projection on the chewing surface of a tooth) to achieve occlusal harmony (a proper bite) between the teeth and a removable denture.

Official code: F.3360. Product type: Preformed cusp. Official classification: Class 1. A performed cusp is a prefabricated device made of plastic or austenitic alloys or alloys containing 75 percent or greater gold and metals of the platinum group intended to be used as a temporary cusp (a projection on the chewing surface of a tooth) to achieve occlusal harmony (a proper bite) before permanent restoration of a tooth.

Official code: F.3400. Product type: Karaya and sodium borate with or without acacia denture adhesive. Official classification: Class 1,3. A karaya and sodium borate with or without acacia denture adhesive is a device composed of karaya and sodium borate with or without acacia intended to be applied to the base of a denture before the denture is inserted into patient's mouth to improve denture retention and comfort.(1)Classification: Class 1 the device contains less than 12 percent by weight of sodium borate;(2)Class 3 the device contains 12 percent or more by weight of sodium borate.

Official code: F.3410. Product type: Ethylene oxide homopolymer and/or carboxymethyl-cellulose sodium denture adhesive. Official classification: Class 1. An ethylene oxide homopolymer and/or carboxymethylcellulose sodium denture adhesive is a device containing ethylene oxide homopolymer and/or carboxymethylcellulose sodium intended to be applied to the base of a denture before the denture is inserted in a patient's mouth to improve denture retention and comfort.

Official code: F.3420. Product type: Carboxymethylcellulose sodium and cationic polyacrylamide polymer denture adhesive. Official classification: Class 3. Acarboxymethylcellulose sodium and cationic polyacrylamide polymer denture adhesive is a device composed of carboxymethylcellulose sodium and cationic polyacrylamide polymer intended to be applied to the base of a denture before the denture is inserted in a patient's mouth to improve denture retention and comfort.

Official code: F.3450. Product type: Ethylene oxide homopolymer and/or karaya denture adhesive. Official classification: Class 1. Ethylene oxide homopolymer and/or karaya denture adhesive is a device composed of ethylene oxide homopolymer and/or karaya intended to be applied to the base of a denture before the denture is inserted in a patient's mouth to improve denture retention and comfort.

Official code: F.3480. Product type: Polyacrylamide polymer (modified cationic) denture adhesive. Official classification: Class 3. A polyacrylamide polymer (modified cationic) denture adhesive is a device composed of polyacrylamide polymer (modified cationic) intended to be applied to the base of a denture before the denture is inserted in a patient's mouth to improve denture retention and comfort.

Official code: F.3490. Product type: Carboxymethylcellulose sodium and/or polyvinylmethylether maleic acid calcium-sodium double salt denture adhesive. Official classification: Class 1. A carboxymethylcellulose sodium and/or polyvinylmethylether maleic acid calcium-sodium double salt denture adhesive is a device composed of carboxymethylcellulose sodium and/or polyvinylmethylether maleic acid calcium-sodium double salt intended to be applied to the base of a denture before the denture is inserted in a patient's mouth to improve denture retention and comfort.

Official code: F.3500. Product type: Polyvinylmethylether maleic anhydride (PVM-. Official classification: Class 3. Polyvinylmethylether maleic anhydride (PVM-MA), acid copolymer, and carboxymethylcellulose sodium (NACMC) denture adhesive is a device composed of polyvinylmethylether maleic anhydride, acid copolymer, and carboxymethylcellulose sodium MA), acid copolymer, and carboxymethylcellulose sodium (NACMC) denture adhesive) intended to be applied to the base of a denture before the denture is inserted in a patient's mouth to improve denture retention and comfort.

Official code: F.3520. Product type: OTC dental appliance cleanser. Official classification: Class 1. An OTC dental appliance cleanser is a device that consists of material in the form of a powder, tablet, or paste that is intended to remove debris from removable prosthetic dental appliances, such as bridges , dentures, braces, and retainers. The dental appliance is removed from the patient's mouth when the appliance is cleaned.

Official code: F.3540. Product type: OTC denture cushion or pad. Official classification: Class 1,2. An OTC denture cushion or pad is a prefabricated or noncustom made disposable device that is intended to improve the fit of a loose or uncomfortable denture, and may be available for purchase over-the-counter. Classification:(1)Class 1 the device is made of wax-impregnated cotton cloth that the patient applies to the base or inner surface of a denture before inserting the denture into the mouth. (2)Class 2 if the OTC denture cushion or pad is made of a material other than wax-impregnated cotton cloth or if the intended use of the device differs from that described in paragraph (1).

Official code: F.3560. Product type: OTC denture reliner. Official classification: Class 2. An OTC denture reliner is a device consisting of a material such as plastic resin that is intended to be applied as a permanent coating or lining on the base or tissue-contacting surface of a denture. The device is intended to replace a worn denture lining and may be available for purchase over the counter.

Official code: F.3570. Product type: OTC denture repair kit. Official classification: Class 2. An OTC denture repair kit is a device consisting of a material, such as a resin monomer system of powder and liquid glues, that is intended to be applied permanently to a denture to mend cracks or breaks. The device may be available for purchase over-the counter.

Official code: F.3580. Product type: Preformed gold denture tooth. Official classification: Class 1. A preformed gold denture tooth is a device composed of austenitic alloys or alloys containing 75 percent or greater gold andmetals of the platinum group intended for use as a tooth or a portion of a tooth in a fixed or removable partial denture.

Official code: F.3590. Product type: Preformed plastic denture tooth. Official classification: Class 2. A preformed plastic denture tooth is a prefabricated device, composed of materials such as methyl methacrylate, that is intended for use as a tooth in a denture.

Official code: F.3600. Product type: Partially fabricated denture kit. Official classification: Class 2. A partially fabricated denture kit is a device composed of connected preformed teeth that is intended for use in constructionof a denture. A denture base is constructed using the patient's mouth as a mold, by partially polymerizing the resin denture base materials while the materials are in contact with the oral tissues. After the denture base is constructed, the connected preformed teeth are chemically bonded to the base.

Official code: F.3630. Product type: Endosseous dental implant abutment. Official classification: Class 2. An endosseous dental implant abutment is a premanufactured prosthetic component directly connected to the endosseous dental implant and is intended for use as an aid in prosthetic rehabilitation.

Official code: F.3640. Product type: Endosseous implant. Official classification: Class 3. An endosseous dental implant is a device made of a material such as titanium or titanium alloy, that is intended to be surgically placed in the bone of the upper or lower jaw arches to provide support for prosthetic devices, such as artificial teeth, in order to restore a patient's chewing function.

Official code: F.3645. Product type: Subperiosteal implant material. Official classification: Class 2. Subperiosteal implant material is a device composed of titanium or cobalt chrome molybdenum intended to construct custom prosthetic devices which are surgically implanted into the lower or upper jaw between the periosteum (connective tissue covering the bone) and supporting bony structures. The device is intended to provide support for prostheses, such as dentures.

Official code: F.3660. Product type: Impression material. Official classification: Class 2. Impression materialis a device composed of materials such as alginate or polysulfide intended to be placed on a preformed impression tray and used to reproduce the structure of a patient's teeth and gums. The device is intended to provide models for study and for production of restorative prosthetic devices, such as gold inlays and dentures.

Official code: F.3661. Product type: Optical Impression Systems for CAD/CAM. Official classification: Class 1. An optical impression system for computer assisted design and manufacturing (CAD/CAM) is a device used to record the topographical characteristics of teeth, dental impressions, or stone models by analog or digital methods for use in the computer- assisted design and manufacturing of dental restorative prosthetic devices. Such systems may consist of a camera, scanner, or equivalent type of sensor and a computer with software.

Official code: F.3670. Product type: Resin impression tray material. Official classification: Class 1. Resin impression tray material is a device intended for use in a two-step dental mold fabricating process. The device consists of a resin material, such as methyl methacrylate, andis used to form a custom impression tray for use in cases in which a preformed impression tray is not suitable, such as the fabrication of crowns, bridges, or full dentures. A preliminary plaster or stonemodel of the patient's teeth and gums is made. Theresin impression tray material is applied to this preliminary study model to form a custom tray. This tray is then filled with impression material and inserted into the patient's mouth to make an impression, from which a final, more precise, model of the patient's mouth is cast.

Official code: F.3680. Product type: Polytetrafluoroethylene (PTFE) vitreous carbon material. Official classification: Class 2. Polytetrafluoroethylene (PTFE) vitreous carbon material is a device composed of polytetrafluoroethylene (PTFE) vitreous carbon intended for use in maxillofacial alveolar ridge augmentation (building up the upper or lower jaw area that contains the sockets in which teeth are rooted) or intended to coat metal surgical implants to be placed in the alveoli (sockets in which the teeth are rooted) or the temporomandibular joints (the joint between the upper and lower jaws).

Official code: F.3690. Product type: Tooth shade resin material. Official classification: Class 2. Tooth shade resin material is a device composed of materials such as bisphenol-A glycidyl methacrylate (Bis-GMA) intended to restore carious lesions or structural defects in teeth.

Official code: F.3710. Product type: Base metal alloy. Official classification: Class 2. A base metal alloy is a device composed primarily of base metals, e.g., nickel, chromium, or cobalt, etc., that is intended for use in fabrication of cast or porcelain-fused-to-metal crown and bridge restorations.

Official code: F.3740. Product type: Retentive and splinting pin. Official classification: Class 1. A retentive and splinting pin is a device made of austenitic alloys or alloys containing 75 percent or greater gold and metals of the platinum group intended to be placed permanently in a tooth to provide retention and stabilization for a restoration, such as a crown, or to join two or more teeth together.

Official code: F.3750. Product type: Bracket adhesive resin and tooth conditioner. Official classification: Class 2. A bracket adhesive resin and tooth conditioner is a device composed of an adhesive compound, e.g., polymethylmethacrylate, etc., intended to cement an orthodontic bracket to a tooth surface.

Official code: F.3760. Product type: Denture relining, repairing, or rebasing resin. Official classification: Class 2. A denture relining, repairing, or rebasing resin is a device composed of materials such as methyl methacrylate, intendedto reline a denture surface that contacts tissue, to repair a fractured denture, or to form a new denture base. This device is not available for over-the-counter (OTC) use.

Official code: F.3765. Product type: Pit and fissure sealant and conditioner. Official classification: Class 2. A pit and fissure sealant and conditioner is a device composed of resin, such as polymethylmethacrylate, intended for use primarily in young children to seal pit and fissure depressions (faults in the enamel) in the biting surfaces of teeth to prevent cavities.

Official code: F.3770. Product type: Temporary crown and bridge resin. Official classification: Class 2. A temporary crown and bridge resin is a device composed of a material, such as polymethylmethacrylate, intended to make a temporary prosthesis, such as a crown or bridge, for use until a permanent restoration is fabricated.

Official code: F.3810. Product type: Root canal post. Official classification: Class 1. A root canal post is a device made of austenitic alloys or alloys containing 75 percent or greater gold and metals of the platinum group intended to be cemented into the root canal of a tooth to stabilize and support a restoration.

Official code: F.3820. Product type: Root canal filling resin. Official classification: Class 2,3. A root canal filling resin is a device composed of material, such as methylmethacrylate, intended for use during endodontic therapy to fill the root canal of a tooth. Classification: (1) Class 2 if chloroform is not used as an ingredient in the device. (2) Class 3 if chloroform is used as an ingredient in the device.

Official code: F.3830. Product type: Endodontic paper point. Official classification: Class 1. An endodontic paper point is a device made of paper intended for use during endodontic therapy to dry, or apply medication to, the root canal of a tooth.

Official code: F.3840. Product type: Endodontic silver point. Official classification: Class 1. An endodontic silver point is a device made of silver intended for use during endodontic therapy to fill permanently the rootcanal of a tooth.

Official code: F.3850. Product type: Gutta percha. Official classification: Class 1. Gutta percha is a device made from coagulated sap of certain tropical trees intended to fill the root canal of a tooth. The gutta percha is softened by heat and inserted into the root canal, where it hardens as it cools.

Official code: F.3890. Product type: Endodontic stabilizing splint. Official classification: Class 2. An endodontic stabilizing splintis a device made of a material, such as titanium, intended to be inserted through the root canal into the upper or lower jaw bone to stabilize a tooth.

Official code: F.3900. Product type: Posterior artificial tooth with a metal insert. Official classification: Class 1. A posterior artificial tooth with a metal insert is a porcelain device with an insert made of austenitic alloys or alloys containing 75 percent or greater gold and metals of the platinum group intended to replace a natural tooth. The device is attached to surrounding teeth by a bridge and is intended to provide both an improvement in appearance and functional occlusion (bite).

Official code: F.3910. Product type: Backing and facing for an artificial tooth. Official classification: Class 1. A backing and facing for an artificial tooth is a device intended for use in fabrication of a fixed or removable dental appliance, such as a crown or bridge. The backing, which is made of gold, is attached to the dental appliance and supports the tooth-colored facing, which is made of porcelain or plastic.

Official code: F.3920. Product type: Porcelain tooth. Official classification: Class 2. A porcelain tooth is a prefabricated device made of porcelain powder for clinical use (F.6660) intended for use in construction of fixed or removable prostheses, such as crowns and partial dentures.

Official code: F.3930. Product type: Tricalcium phosphate granules for dental bone repair. Official classification: Class 2,3. Bone grafting material is a material such as hydroxyapatite, tricalcium phosphate, polylactic and polyglycolic acids, or collagen that is intended to fill, augment, or reconstruct periodontal or bony defects of the oral and maxillofacial region. Classification: (1) Class 2 devices do not contain medicine. (2) Class 3 devices contain medicine.

Official code: F.3940. Product type: Total temporomandibular. Official classification: Class 3. A total temporomandibular joint prosthesis is a device that is intended to be implanted in the human jaw to replace the mandibular joint prosthesiscondyle and augment the glenoid fossa to functionally reconstruct the temporomandibular joint.

Official code: F.3950. Product type: Glenoid fossa prosthesis. Official classification: Class 3. A glenoid fossa prosthesis is a device that is intended to be implanted in the temporomandibular joint to augment a glenoid fossa or to provide an articulation surface for the head of a mandibular condyle.

Official code: F.3960. Product type: Mandibular condyle prosthesis. Official classification: Class 3. A mandibular condyle prosthesis is a device that is intended to be implanted in the human jaw to replace the mandibular condyle and to articulate within a glenoid fossa.

Official code: F.3970. Product type: Interarticular disc prosthesis (interpositional implant). Official classification: Class 3. An interarticular disc prosthesis (interpositional implant) is a device that is intended to be an interface between the natural articulating surface of the mandibular condyle and glenoid fossa.

Official code: F.3980. Product type: Endosseous dental implant accessories. Official classification: Class 1. Endosseous dental implant accessories are manually powered devices intended to aid in the placement or removal of endosseous dental implants and abutments, prepare the site for placement of endosseous dental implants or abutments, aid in the fitting of endosseous dental implants or abutments, aid in the fabrication of dental prosthetics, and be used as an accessory with endosseous dental implants when tissue contact will last less than 1 hour. These devices include drill bits, screwdrivers, countertorque devices, placement and removal tools, laboratory pieces used for fabrication of dental prosthetics, and trial abutments.

Official code: F.4120. Product type: Bone cutting instrument and accessories. Official classification: Class 2. A bone cutting instrument and accessories is a metal device intended for use in reconstructive oral surgery to drill or cut into the upper or lower jaw and may be used to prepare bone to insert a wire, pin, or screw. The device includes the manual bone drilland wire driver, powered bone drill, rotary bone cutting handpiece, and AC-powered bone saw.

Official code: F.4130. Product type: Intraoral dental drill. Official classification: Class 1. An intraoral dental drill is a rotary device intended to be attached to a dental handpiece to drill holes in teeth to securecast or preformed pins to retain operative dental appliances.

Official code: F.4200. Product type: Dental handpiece and accessories. Official classification: Class 1. A dental handpiece and accessories is an AC-powered, water-powered, air-powered, or belt-driven, hand-held device that may include a foot controller for regulation of speed and direction of rotation or a contra-angle attachment for difficult to reach areas intended to prepare dental cavities for restorations, such as fillings, and for cleaning teeth.

Official code: F.4465. Product type: Gas-powered jet injector. Official classification: Class 2. A gas-powered jet injector is a syringe device intended to administer a local anesthetic. The syringe is powered by a cartridge containing pressurized carbon dioxide which provides the pressure to force the anesthetic out of the syringe.

Official code: F.4475. Product type: Spring-powered jet injector. Official classification: Class 2. A spring-powered jet injector is a syringe device intended to administer a local anesthetic. The syringe is powered by a spring mechanism which provides the pressure to force the anesthetic out of the syringe.

Official code: F.4535. Product type: Dental diamond instrument. Official classification: Class 1. A dental diamond instrument is anabrasive device intended to smooth tooth surfaces during the fitting of crowns or bridges. The device consists of a shaft which is inserted into a handpiece and a head which has diamond chips imbedded into it. Rotation of the diamond instrument provides an abrasive action when it contacts a tooth.

Official code: F.4565. Product type: Dental hand instrument. Official classification: Class 1. A dental hand instrument is a hand-held device intended to perform various tasks in general dentistry and oral surgery procedures. The device includes the operative burnisher, operative amalgam carrier, operative dental amalgam carver, surgical bone chisel, operative amalgam and foil condenser, endodontic curette, operative curette, periodontic curette, surgical curette, dental surgical elevator, operative dental excavator, operative explorer surgical bone file, operative margin finishing file, periodontic file, periodontic probe, surgical rongeur forceps, surgical tooth extractor forceps, surgical hemostat, periodontic hoe, operativematrix contouring instrument, operative cutting instrument, operative margin finishing periodontic knife, periodontic marker, operative pliers, endodontic root canal plugger, endodontic root canal preparer, surgical biopsy punch, endodontic pulp canal reamer, crown remover, periodontic scaler, collar andcrown scissors, endodontic pulp canal filling material spreader, surgical osteotome chisel, endodontic broach, dental wax carver, endodontic pulp canal file, hand instrument for calculus removal, dental depth gauge instrument, plastic dental filling instrument, dental instrument handle, surgical tissue scissors, mouth mirror, orthodontic band driver, orthodontic band pusher, orthodontic band setter, orthodontic bracket aligner, orthodontic pliers, orthodontic ligature tucking instrument, forceps, for articulation paper, forceps for dental dressing, dental matrix band, matrix retainer, dental retractor, dental retractor accessories, periodontic or endodontic irrigating syringe, and restorative or impression material syringe.

Official code: F.4600. Product type: Intraoral ligature and wire lock. Official classification: Class 2. An intraoral ligature and wire lock is a metal device intended to constrict fractured bone segments in the oral cavity. The bone segments are stabilized by wrapping the ligature (wire) around the fractured bone segments and locking the ends together.

Official code: F.4620. Product type: Fiber optic dental light. Official classification: Class 1. A fiber optic dental light is a device that is a light, usually AC-powered, that consists of glass or plastic fibers which have special optical properties. The device is usually attached to a dental handpiece and is intended to illuminate a patient's oral structures.

Official code: F.4630. Product type: Dental operating light. Official classification: Class 1. A dental operating light, including the surgical headlight, is an AC-powered device intended to illuminate oral structures and operating areas.

Official code: F.4730. Product type: Dental injecting needle. Official classification: Class 1. A dental injecting needle is a slender, hollow metal device with a sharp point intended to be attached to a syringe to injectlocal anesthetics and other drugs.

Official code: F.4760. Product type: Bone plate. Official classification: Class 2. A bone plate is a metal device intended to stabilize fractured bonestructures in the oral cavity. The bone segments are attached to the plate with screws to prevent movement of the segments.

Official code: F.4770. Product type: Temporary mandibular condyle reconstruction plate. Official classification: Class 2. A temporary mandibular condyle reconstruction plate is a device that isintended to stabilize mandibular bone and provide for temporary reconstruction of the mandibular condyle until permanent reconstruction is completed in patients who have undergone respective surgical procedures requiring removal of the mandibular condyleand mandibular bone. This device is not intended for treatment of temporomandibular joint disorders.

Official code: F.4840. Product type: Rotary scaler. Official classification: Class 2. A rotary scaler is an abrasive device intended to be attached to a powered handpiece to remove calculus deposits from teeth during dental cleaning and periodontal (gum) therapy.

Official code: F.4850. Product type: Ultrasonic scaler. Official classification: Class 2. An ultrasonic scaler is a device intended for use during dental cleaning and periodontal (gum) therapy to remove calculus deposits from teeth by application of an ultrasonic vibrating scaler tip to the teeth.

Official code: F.4880. Product type: Intraosseous fixation screw or wire. Official classification: Class 2. An intraosseous fixation screw or wire is a metal device intended to be inserted into fractured jaw bone segments to preventtheir movement.

Official code: F.4920. Product type: Dental electrosurgical unit. Official classification: Class 2. A dental electrosurgical unit and accessories is an AC-powered device consisting of a controlled power source and a set of cutting and accessoriesand coagulating electrodes. This device is intended to cut or remove soft tissue or to control bleeding during surgical procedures in the oral cavity. Depending on the mode of operational selection,it cuts through soft tissue or coagulates the tissue after an electrical current passes through the tip of the electrode into the tissue..

Official code: F.5410. Product type: Orthodontic appliance and accessories. Official classification: Class 1. An orthodontic appliance and accessories is a device intended for use in orthodontic treatment. The device is affixed to a tooth so that pressure can be exerted on the teeth. This device includes the preformed orthodontic band, orthodontic band material, orthodontic elastic band, orthodontic metal bracket, orthodontic wire clamp, preformed orthodontic space maintainer, orthodontic expansion screw retainer, orthodontic spring, orthodontic tube, and orthodontic wire.

Official code: F.5470. Product type: Orthodontic plastic bracket and aligner. Official classification: Class 2. (a)An orthodontic plastic bracket is a plastic device intended to be bonded to a tooth to apply pressure to a tooth from a flexible orthodontic wire to alter its position. (b)Orthodontic aligners are devices that treat teeth with minor malocclusions and can gently move the position of the teeth.The thermoplastic resin device, with patient scanning software or/and hardware, isto design and create a series of plastic orthodontic appliances and to gradually move the teeth by using the patient's dental digital scan file.

Official code: F.5500. Product type: Extraoral orthodontic headgear. Official classification: Class 2. An extraoral orthodontic headgear is a device intended for use with an orthodontic appliance to exert pressure on the teeth from outside the mouth. The headgear has a strap intended to wrap around the patient's neck or head and an inner bow portion intended to be fastened to the orthodontic appliance in the patient's mouth.

Official code: F.5525. Product type: Preformed tooth positioner. Official classification: Class 1. A preformed tooth positioner is a plastic device that is made for an impression of a bite intended to prevent a patient's teeth from shifting position or to maintain teeth in a final position after orthodontic appliances (braces) have been removed. The patient bites down on the device for several hours a day to stabilize the position of the teeth.

Official code: F.5560. Product type: Electrical salivary stimulatory system. Official classification: Class 2. An electrical salivary stimulatory system is anintraoral device that is intended to electrically stimulate a relative increase in saliva production.

Official code: F.5570. Product type: Intraoral devices for snoring and intraoral devices for snoring and obstructive sleep apnea. Official classification: Class 2. Intraoral devices for snoring and intraoral devices for snoring and obstructive sleep apnea are devices that are worn duringsleep to reduce the incidence of snoring and to treat obstructivesleep apnea. The devices are designed to increase the patency of the airway and to decrease air turbulence and airway obstruction. The classification includes palatal lifting devices, tongue retaining devices, and mandibular repositioning devices.

Official code: F.6010. Product type: Abrasive device and accessories. Official classification: Class 1. An abrasive device and accessories is a device constructed of various abrasives, such as diamond chips, that are glued to shellac- based paper. The device is intended to remove excessive restorative materials, such as gold, and to smooth rough surfaces from oral restorations, such as crowns. The device is attached to a shank that is held by a handpiece. The device includes the abrasive disk, guard for an abrasive disk, abrasive point, polishing agent strip, and polishing wheel.

Official code: F.6030. Product type: Oral cavity abrasive polishing agent. Official classification: Class 1. An oral cavity abrasive polishing agent is a device in paste or powder form that contains an abrasive material, such as silica pumice, intended to remove debris from the teeth. The abrasive polish is applied to the teeth by a handpiece attachment (prophylaxis cup).

Official code: F.6050. Product type: Saliva absorber. Official classification: Class 1. A saliva absorber is a device made of paper or cotton intended to absorb moisture from the oral cavity during dental procedures.

Official code: F.6070. Product type: Ultraviolet activator for polymerization. Official classification: Class 2. An ultraviolet activator for polymerization is a device that produces ultraviolet radiation intended to polymerize (set) resinous dental pit and fissure sealants or restorative materials by transmission of light through a rod.

Official code: F.6080. Product type: Airbrush. Official classification: Class 2. An airbrush is an AC-powered device intended for use in conjunction with articulation paper. The device uses air-driven particles to roughen the surfaces of dental restorations. Uneven areas of the restorations are then identified by use of articulation paper.

Official code: F.6100. Product type: Anesthetic warmer. Official classification: Class 1. An anesthetic warmer is an AC-powered device into which tubes containing anesthetic solution are intended to be placed to warm them prior to administration of the anesthetic.

Official code: F.6140. Product type: Articulation paper. Official classification: Class 1. Articulation paper is a device composed of paper coated with an ink dye intended to be placed between the patient's upper and lower teeth when the teeth are in the bite position to locate uneven or high areas.

Official code: F.6200. Product type: Base plate shellac. Official classification: Class 1. Base plant shellac is a device composed of shellac intended to rebuild the occlusal rim of full or partial dentures.

Official code: F.6250. Product type: Dental chair and accessories. Official classification: Class 1. A dental chair and accessories is a device, usually AC-powered, in which a patient sits. The device is intended to properly position a patient to perform dental procedures. A dental operative unit may be attached.

Official code: F.6290. Product type: Prophylaxis cup. Official classification: Class 1. A prophylaxis cup is a device made of rubber intended to be held by a dental handpiece and used to apply polishing agents during prophylaxis (cleaning). The dental handpiece spins the rubber cup holding the polishing agent and the user applies it to the teeth to remove debris.

Official code: F.6300. Product type: Rubber dam and accessories. Official classification: Class 1. A rubber dam and accessories is a device composed of a thin sheet of latex with a hole in the center intended to isolate a tooth from fluids in the mouth during dental procedures, such as filling a cavity preparation. The device is stretched around a tooth by inserting a tooth through a hole in the center. The device includes the rubber dam, rubber dam clamp, rubber dam frame, and forceps for a rubber dam clamp.

Official code: F.6350. Product type: Ultraviolet detector. Official classification: Class 2. An ultraviolet detector is a device intended to provide a source of ultraviolet light which is used to identify otherwise invisible material, such as dental plaque, present in or on teeth.

Official code: F.6475. Product type: Heat source for bleaching teeth. Official classification: Class 1. A heat source for bleaching teeth is adevice that consists of a light or an electric heater intended to apply heat to a tooth after it is treated with a bleaching agent.

Official code: F.6570. Product type: Impression tube. Official classification: Class 1. An impression tube is a device consisting of a hollow copper tube intended to take an impression of a single tooth. The hollow tube is filled with impression material. One end of the tube is sealed with a softened material, such as wax, the remaining end is slipped over the tooth to make the impression.

Official code: F.6640. Product type: Dental operative unit and accessories. Official classification: Class 1. A dental operative unit and accessories is an AC-powered device that is intended to supply power to and serve as a base for other dental devices, such as a dental handpiece, a dental operating light, an air or water syringe unit, and oral cavity evacuator, a suction operative unit, and other dental devices and accessories. The device may be attached to a dental chair.

Official code: F.6660. Product type: Porcelain powder for clinical use. Official classification: Class 2. Porcelain powder for clinical use is a device consisting of a mixture of kaolin, felspar, quartz, or other substances intended for use in the production of artificial teeth in fixed or removable dentures, of jacket crowns, facings, and veneers. The device is used in prosthetic dentistry by heating the powder mixture to a high temperature in an oven to produce a hard prosthesis with a glass-like finish.

Official code: F.6710. Product type: Boiling water sterilizer. Official classification: Class 1. A boiling water sterilizer is an AC-powered device that consists of a container for boiling water. The device is intended to sterilize dental and surgical instruments by submersion in the boiling water in the container.

Official code: F.6730. Product type: Endodontic dry heat sterilizer. Official classification: Class 3. An endodontic dry heat sterilizer is a device intended to sterilize endodontic and other dental instruments by the application of dry heat. The heat is supplied through glass beads which have been heated by electricity.

Official code: F.6770. Product type: Cartridge syringe. Official classification: Class 2. A cartridge syringe is a device intended to inject anesthetic agents subcutaneously or intramuscularly. The device consists of a metal syringe body into which a disposable, previously filled, glass carpule (a cylindrical cartridge) containing anestheticis placed. After attaching a needle to the syringe body andactivating the carpule by partially inserting the plunger on the syringe, the device is used to administer an injection to the patient.

Official code: F.6870. Product type: Disposable fluoride tray. Official classification: Class 1. A disposable fluoride tray is a device made of styrofoam intended to apply fluoridetopically to the teeth. To use the tray, the patient bites down on the tray which has been filled with a fluoride solution.

Official code: F.6880. Product type: Preformed impression tray. Official classification: Class 1. A preformed impression tray is a metal or plastic device intended to hold impression material, such as alginate, to make an impression of a patient's teeth or alveolar process (bony tooth sockets) to reproduce the structure of a patient's teeth and gums.

Official code: F.6890. Product type: Intraoral dental wax. Official classification: Class 1. Intraoral dental wax is a device made of wax intended to constructpatterns from which custom made metal dental prostheses, such as crowns and bridges, are cast. In orthodontic dentistry, the device is intended to make a pattern of a patient's bite to make study models of the teeth.

Official code: F.9999. Product type: Others(Dental Devices)1,. Official classification: Class 2,3. The products excluded from the above-classification are adopted in this classification and specified by the central competent health authority.

Official code: G.0001. Product type: Cochlear implant. Official classification: Class 3. A cochlear implant establishes hearing capability for a hearing impaired patient by using electrical signals (e.g., electrical currents, etc.) to stimulate auditory nerve.

Official code: G.1050. Product type: Audiometer. Official classification: Class 1,2. An audiometer or automated audiometer is an electroacoustic device that produces controlled levels of test tones and signals intended for use in conducting diagnostic hearing evaluations and assisting in the diagnosis of possible otologic disorders. Classification: (1) Class 1;(2) Class 2: otoacoustic emission device.

Official code: G.1070. Product type: Short increment sensitivity index (SISI) adapter. Official classification: Class 1. A short increment sensitivity index (SISI) adapter is a device used with an audiometer in diagnostic hearing evaluations. A SISI adapter provides short periodic sound pulses in specific small decibel increments that are intended to be superimposed on the audiometer's output tone frequency.

Official code: G.1090. Product type: Auditory impedance tester. Official classification: Class 2. An auditory impedance tester is a device that is intended to change the air pressure in the external auditory canal and measure and graph the mobility characteristics of the tympanic membrane to evaluate thefunctional condition of the middle ear. The device is used to determine abnormalities in the mobility of the tympanic membrane due to stiffness, flaccidity, or the presence of fluid in the middle ear cavity. The device is also used to measure the acousticreflex threshold from contractions of the stapedial muscle, to monitor healing of tympanic membrane grafts or stapedectomies, or to monitor followup treatment for inflammation of the middle ear.

Official code: G.1100. Product type: Earphone cushion for audiometric testing. Official classification: Class 1. An earphone cushion for audiometric testing is a device that is used to cover an audiometer earphone during audiometric testing to provide an acoustic coupling (sound connection path) between the audiometer earphone and the patient's ear.

Official code: G.1120. Product type: Electronic noise generator for audiometric testing. Official classification: Class 2. An electronic noise generator for audiometric testing is a device that consists of a swept frequency generator, an amplifier,and an earphone. It is intended to introduce a masking noise into the non-test ear during an audiometric evaluation. The device minimizes the non-test ear's sensing of test tones and signals being generated for the ear being tested.

Official code: G.1325. Product type: Electroglottograph. Official classification: Class 2. An electroglottograph is an AC-powered device that employs a pair of electrodes that areplaced in contact with the skin on both sides of the larynx and held in place by a collar. It is intended to measure the electrical impedance of the larynx to aid inassessing the degree of closure of the vocal cords, confirm laryngeal diagnosis, aid behavioral treatment of voice disorders, and aid research concerning the laryngeal mechanism.

Official code: G.1500. Product type: Gustometer. Official classification: Class 1. A gustometer is a battery-powered device that consists of two electrodes that are intended to be placed on both sides of the tongue at different taste centers and that provides a galvanic stimulus resulting in taste sensation. It is used for assessing the sense of taste.

Official code: G.1600. Product type: Olfactory test device. Official classification: Class 1. An olfactory test device is used to determine whether an olfactory loss is present. The device includes one or more odorants that are presented to the patient's nose to subjectively assess the patient's ability to perceive odors.

Official code: G.1800. Product type: Air or water caloric stimulator. Official classification: Class 1. An air or water caloric stimulator is a device that delivers a stream of air or water to the ear canal at controlled rates of flow and temperature and that is intended for vestibular function testing of a patient's body balance system. The vestibular stimulation of the semicircular canals produce involuntary eye movements that are measured and recorded by a nystagmograph.

Official code: G.1820. Product type: Surgical nerve stimulator/locator. Official classification: Class 2. A surgical nerve stimulator/locator is a device that is intended to provide electrical stimulation to the body to locate andidentify nerves and to test their excitability.

Official code: G.1925. Product type: Toynbee diagnostic tube. Official classification: Class 1. The toynbee diagnostic tube is a listening device intended to determine the degree of openness of the eustachian tube.

Official code: G.3300. Product type: Hearing aid. Official classification: Class 1,2. A hearing aid is wearable sound-amplifying device that is intended to compensatefor impaired hearing. This generic type of device includes the air-conduction hearing aid and the bone-conduction hearing aid, but excludes the group hearing aid or group auditory trainer (G.3320), master hearing aid (G.3330), and tinnitus masker (G.3400). Classification: (1) Class 1 for the air-conduction hearing aid. (2) Class 2 for the bone-conduction hearing aid.

Official code: G.3310. Product type: Hearing aid calibrator and analysis system. Official classification: Class 2. A hearing aid calibrator and analysis system is an electronic reference device intended to calibrate and assess the electroacoustic frequency and sound intensity characteristics emanating from a hearing aid, master hearing aid, group hearing aid or group auditory trainer. The device consists of an acoustic complex of known cavity volume, a sound level meter, a microphone, oscillators, frequency counters, microphone amplifiers, a distortion analyzer, a chart recorder, and a hearing aid test box.

Official code: G.3315. Product type: Tympanic membrane contact hearing aid. Official classification: Class 2. A tympanic membrane contact hearing aid is a device that compensates for impaired hearing. Amplified sound is transmitted by vibrating the tympanic membrane through a transducer that is in direct contact with the tympanic membrane.

Official code: G.3320. Product type: Group hearing aid or group auditory trainer. Official classification: Class 2. A group hearing aid orgroup auditory trainer is a hearing aid that is intended for use in communicating simultaneously with one or more listeners having hearing impairment. The device is used with an associated transmitter microphone. It may be either monaural or binaural, andit provides coupling to the ear through either earphones or earmolds. The generic type of device includes three types of applications: hardwire systems, inductance loop systems, and wireless systems.

Official code: G.3330. Product type: Master hearing aid. Official classification: Class 2. A master hearing aid is anelectronic device intended to simulate a hearing aid during audiometric testing. It has adjustable acoustic output levels, such as those for gain, output, and frequency response. The device is used to select and adjust a person's wearable hearing aid.

Official code: G.3400. Product type: Tinnitius masker. Official classification: Class 2. A tinnitus masker is an electronic device intended to generate noise of sufficient intensity and bandwidth to mask ringing inthe ears or internal head noises. Because the device is able to mask internal noises, it is also used as anaid in hearing external noises and speech.

Official code: G.3430. Product type: Middle ear mold. Official classification: Class 2. A middle ear mold is a preformed device that is intended to be implanted to reconstruct the middle ear cavity during repair of the tympanic membrane. The device permits an ample air-filled cavity to be maintained in the middle ear and promotes regeneration of the mucous membrane lining of the middle ear cavity. A middle ear mold is made of materials such as polyamide, polytetrafluoroethylene, silicone elastomer, or polyethylene, but does not contain porous polyethylene.

Official code: G.3450. Product type: Partial ossicular replacement prosthesis. Official classification: Class 2. A partial ossicular replacement prosthesis is a device intended to be implanted for the functional reconstruction of segmentsof the ossicular chain and facilitates the conduction of sound wave from the tympanic membrane to the inner ear. The device is made of materials such as stainless steel, tantalum, polytetrafluoroethylene, polyethylene, polytetrafluoroethylene with carbon fibers composite, absorbable gelatin material, porous polyethylene, or from a combination of these materials.

Official code: G.3495. Product type: Total ossicular replacement prosthesis. Official classification: Class 2. A total ossicular replacement prosthesis is a device intended to be implanted for the total functional reconstruction of theossicular chain and facilitates the conduction of sound waves from the tympanic membrance to the inner ear. The device is made of materials such as polytetrafluoroethylene, polytetrafluoroethylene with vitreous carbon fibers composite, porous polyethylene, or froma combination of these materials.

Official code: G.3540. Product type: Prosthesis modification instrument for ossicular replacement surgery. Official classification: Class 1. A prosthesis modification instrument for ossicular replacement surgery is a device intended for use by a surgeon to construct ossicular replacements. This generic type of device includes the ear, nose, and throat cutting block,wire crimper, wire bending die, wire closure forceps, piston cutting jib, gelfoamTMpunch, wire cutting scissors, and ossicular finger vise.

Official code: G.3620. Product type: Ear, nose, and throat synthetic polymer material. Official classification: Class 2. Ear, nose, and throat synthetic polymer material is a device material that is intended to be implanted for use as a space-occupying substance in the reconstructive surgery of the head and neck. The device is used, for example, in augmentation rhinoplasty and in tissue defect closures in the esophagus. The device is shaped and formed by the surgeon to conform to the patient's needs. This generic type of device is made of material such as polyamide mesh or foil and porous polyethylene.

Official code: G.3695. Product type: Mandibular implant facial prosthesis. Official classification: Class 2. A mandibular implant facial prosthesis is a device that is intended to be implanted for use in the functional reconstructionof mandibular deficits. The device is made of materials such as stainless steel, tantalum, titanium, cobalt-chromium based alloy, polytetrafluoroethylene, silicone elastomer, polyethylene, polyurethane, or polytetrafluoroethylene with carbon fibers composite.

Official code: G.3730. Product type: Laryngeal prosthesis (Taub design). Official classification: Class 2. A laryngeal prosthesis (Taub design) isa device intended to direct pulmonary air flow to the pharynx in the absence of the larynx, thereby permitting esophageal speech. The device is interposed between openings in the trachea and the esophagus and may be removed and replaced each day by the patient. During phonation, air from the lungs is directed to flow through the device and over the esophageal mucosa to provide a sound source that is articulated as speech.

Official code: G.3760. Product type: Sacculotomy tack (Cody tack). Official classification: Class 2. A sacculotomy tack (Cody tack) is a device that consists of a pointed stainless steel tack intended to be implanted to relieve the symptoms of vertigo. The device repetitively ruptures the utricular membrane as the membrane expands under increased endolymphatic pressure.

Official code: G.3820. Product type: Endolymphatic shunt. Official classification: Class 2. An endolymphatic shunt is a device that consists of a tube or sheet intended to be implanted to relieve the symptoms of vertigo. The device permits the unrestricted flow of excess endolymph from the distended end of the endolymphatic system into the mastoid cavity where resorption occurs. This device is made of polytetrafluoroethylene or silicone elastomer.

Official code: G.3850. Product type: Endolymphatic shunt tube with valve. Official classification: Class 2. An endolymphatic shunt tube with valve is a device that consists of a pressure-limiting valve associated with a tube intended to be implanted in the inner ear to relieve symptoms of vertigo and hearing loss due to endolymphatic hydrops (increase in endolymphatic fluid) of Meniere's disease.

Official code: G.3880. Product type: Tympanostomy tube. Official classification: Class 2. A tympanostomy tube is a device that is intended to be implanted for ventilation or drainage of the middle ear. The device is inserted through the tympanic membrane to permit a free exchange of air between the outer ear and middle ear. A type of tympanostomy tube known as the malleous clip tube attaches to the malleous to provide middle ear ventilation. The device is made of materials such as polytetrafluoroethylene, polyethylene, silicon elastomer, or porous polyethylene.

Official code: G.3900. Product type: Nasal dilator. Official classification: Class 1. A nasal dilator is a device intended to provide temporary relief from transient causes of breathing difficulties resulting from structural abnormalities and/or transient causes of nasal congestion associated with reduced nasal airflow. The device decreases airway resistance and increases nasal airflow. Theexternal nasal dilator is constructed from one or more layers of material upon which a spring material is attached, with a skin adhesive applied to adhere to the skin of the nose; it acts with a pulling action to open the nares. The internal nasal dilatoris constructed from metal or plastic and is placed inside the nostrils; it acts by pushing the nostrils open or by gently pressing on the columella.

Official code: G.3930. Product type: Tympanostomy tube with semipermeable membrane. Official classification: Class 2. A tympanostomy tube with a semipermeable membrane is a device intended to be implanted for ventilation or drainage of the middle ear and for preventing fluids from entering the middle ear cavity. The device is inserted through the tympanic membrane to permit a free exchange of air between the outer ear andmiddle ear. The tube portion of the device is made of silicone elastomer or porous polyethylene, and the membrane portion is made of polytetrafluoroethylene.

Official code: G.3950. Product type: Transcutaneous air conduction hearing aid system. Official classification: Class 2. A transcutaneous air conduction hearing aid system is a wearable sound-amplifying device intended to compensate for impaired hearing without occluding the ear canal. The device consists of an air conduction hearing aid attached to a surgically fittedtube system, which is placed through soft tissue between the post auricular region and the outer ear canal.

Official code: G.4100. Product type: Epistaxis balloon. Official classification: Class 1. An epistaxis balloon is a device consisting of an inflatable balloon intended to control internal nasal bleeding by exertingpressure against the sphenopalatine artery.

Official code: G.4140. Product type: Ear, nose, and throat bur. Official classification: Class 1. An ear, nose, and throat bur is a device consisting of an interchangeable drill bit that is intended for use in an ear, nose,and throat electric or pneumatic surgical drill for incising or removing bone in the ear, nose, or throat area. The bur consists of a carbide cutting tip on a metal shank or a coating of diamond on a metal shank. The device is used in mastoid surgery, frontal sinus surgery, and surgery of the facial nerves.

Official code: G.4175. Product type: Nasopharyngeal catheter. Official classification: Class 1. A nasopharyngeal catheter is a device consisting of a bougie or filiform catheter that is intended for use in probing or dilating the eustachian tube. This generic type of device includes eustachian catheters.

Official code: G.4180. Product type: Eustachian tube balloon dilation system. Official classification: Class 2. A Eustachian tube balloon dilation system is a device that includes a flexible catheter attached to an inflatable balloon. The system is intended for use in dilating the cartilaginous portion of the Eustachian tube for treating persistent Eustachian tube dysfunction.

Official code: G.4250. Product type: Ear, nose, and throat electric or pneumatic surgical drill. Official classification: Class 2. An ear, nose, and throat electric or pneumatic surgical drill is a rotating drilling device, including the handpiece, that isintended to drive various accessories, such as an ear, nose, and throat bur (G.4140), for the controlled incision or removal of bone in the ear, nose, and throat area.

Official code: G.4350. Product type: Ear, nose, and throat fiberoptic light source and carrier. Official classification: Class 1. An ear, nose, and throat fiberoptic light source and carrier is an AC-powered device that generates and transmits light through glass of plastic fibers and that is intended to provide illumination at the tip of an ear, nose, or throat endoscope. Endoscopic devices which utilize fiberoptic light sources and carriers include the bronchoscope, esophagoscope, laryngoscope, mediastinoscope, laryngeal-bronchial telescope, and nasopharyngoscope.

Official code: G.4420. Product type: Ear, nose, and throat manual surgical instrument. Official classification: Class 1. An ear, nose, and throat manual surgical instrument is one of a variety of devices intended for use in surgical procedures to examine or treat the bronchus, esophagus, trachea, larynx, pharynx, nasal and paranasal sinus, or ear. This generic type of device includes the esophageal dilator; tracheal bistour (a long, narrow surgicalknife); tracheal dilator; tracheal hook; laryngeal injection set; laryngeal knife; laryngeal saw; laryngeal trocar; laryngectomy tube; adenoid curette; adenotome; metal tongue depressor; mouth gag; oral screw; salpingeal curette; tonsillectome; tonsil guillotine; tonsil screw; tonsil snare; tonsil suction tube; tonsil suturing hook; antom reforator; ethmoid curette; frontal sinus-rasp; nasal curette; nasal rasp; nasal rongeur; nasal saw; nasal scissors; nasal snare; sinus irrigator; sinus trephine; ear curette; ear excavator; ear rasp; ear scissor, ear snare; ear spoon; ear suction tube; malleous ripper; mastoid gauge; microsurgical ear chisel; myringotomy tube inserter; ossici holding clamp; sacculotomy tack inserter;vein press; wire ear loop; microrule; mirror; mobilizer; ear, nose, and throat punch; ear, nose and throat knife; and ear, nose, and throat trocar.

Official code: G.4490. Product type: Argon laser for otology,. Official classification: Class 2. The argon laser device for use in otology, rhinology, and laryngology is an electro-optical device which produces coherent, rhinology, and laryngologyelectromagnetic radiation with principal wavelength peaks of 488 and 514 nanometers. In otology, the device is used for the purpose of coagulating and vaporizing soft and fibrous tissues, including osseous tissue. Inrhinology and laryngology, the device is used to coagulate and vaporize soft and fibrous tissues, but not including osseous tissues.

Official code: G.4500. Product type: Ear, nose, and throat microsurgical carbon dioxide laser. Official classification: Class 2. An ear, nose, and throat microsurgical carbon dioxide laser is a device intended for the surgical excision of tissue from the ear, nose, and throat area. The device is used, for example, in microsurgical procedures to excise lesions and tumors of the vocalcords and adjacent areas.

Official code: G.4680. Product type: Bronchoscope (flexible or rigid) and accessories. Official classification: Class 2. A bronchoscope (flexible or rigid) and accessories is a tubular endoscopic device with any of a group of accessory devices which attach to the bronchoscope and is intended to examine or treat the larynx and tracheobronchial tree. It is typically used with a fiberoptic light source and carrier to provide illumination. The device is made of materials such as stainless steel or flexible plastic. This generic type of device includes the rigid ventilating bronchoscope, rigid nonventilating bronchoscope, nonrigid bronchoscope, laryngeal-bronchial telescope, flexible foreign body claw, bronchoscope tubing, flexible biopsy forceps, rigid biopsy curette, flexible biopsy brush, rigid biopsy forceps, flexible biopsy curette, and rigid bronchoscope aspirating tube, but excludes the fiberoptic light source and carrier.

Official code: G.4710. Product type: Esophagoscope (flexible or rigid) and accessories. Official classification: Class 2. An esophagoscope (flexible or rigid) and accessories is a tubular endoscopic device with any of a group of accessorydevices which attach to the esophagoscope and is intended to examine or treat esophageal malfunction symptoms, esophageal or mediastinal disease, or to remove foreign bodies from the esophagus. When inserted, the device extends from the area of the hypopharynx to the stomach. It is typically used with a fiberoptic light source and carrier to provide illumination. The device is made of materials such as stainless steel or flexible plastic. This generic type of device includes the flexible foreign body claw, flexible biopsy forceps, rigid biopsy curette, flexible biopsy brush, rigid biopsy forceps and flexible biopsy curette, but excludes the fiberoptic light source and carrier.

Official code: G.4720. Product type: Mediastinoscope and accessories. Official classification: Class 2. A mediastinoscope and accessories is atubular tapered electrical endoscopic device with any of a group of accessory devices which attach to the mediastinoscope and is intended to examine or treat tissue in the area separating the lungs. The device is inserted transthoracicly and is used in diagnosis of tumors and lesions and to determine whether excision of certain organs or tissues is indicated. It is typically used with a fiberoptic light source and carrier to provide illumination. The device ismade of materials such as stainless steel. Thisgeneric type of device includes the flexible foreign body claw, flexible biopsy forceps, rigid biopsy curette, flexible biopsy brush, rigid biopsy forceps, and flexible biopsy curette, but excludes the fiberoptic light source and carrier.

Official code: G.4750. Product type: Laryngostroboscope. Official classification: Class 1. A laryngostroboscope is a device that is intended to allow observation of glottic action during phonation. The device operates by focusing a stroboscopic light through a lens for direct or mirror reflected viewing of glottic action. The lightand microphone that amplifies acoustic signals from the glottic area may or may not contact the patient.

Official code: G.4760. Product type: Nasopharyngoscope. Official classification: Class 2. A nasopharyngoscope (flexible or rigid) and accessories is a tubular endoscopic devicewith any of a group of accessory devices (flexible or rigid) and accessories which attach to the nasopharyngoscope and is intended to examine or treat the nasal cavity and nasal pharynx. It is typicallyused with a fiberoptic light source and carrier to provide illumination. The device is made of materials such as stainless steel and flexible plastic. This generic type of device includes the antroscope, nasopharyngolaryngoscope, nasosinuscope, nasoscope, postrhinoscope, rhinoscope, salpingoscope, flexible foreign body claw, flexible biopsy forceps, rigid biopsy curette, flexible biopsy brush, rigid biopsy forceps and flexible biopsy curette, but excludes the fiberoptic light source and carrier.

Official code: G.4770. Product type: Otoscope. Official classification: Class 1. An otoscope is a device intended to allow inspection of the external ear canal and tympanic membrane under magnification. The device provides illumination of the ear canal for observation by using an AC- or battery-powered light source and an optical magnifying system.

Official code: G.4780. Product type: Intranasal splint. Official classification: Class 1. An intranasal splint is intended to minimize bleeding and edema and to prevent adhesions between the septum and the nasal cavity. It is placed in the nasal cavity after surgery or trauma. The intranasal splint is constructed from plastic, silicone, or absorbent material.

Official code: G.4800. Product type: Bone Particle collector. Official classification: Class 1. A bone particle collector is a filtering device intended to be inserted into a suction tube during the early stages of otologic surgery to collect bone particles for future use.

Official code: G.5220. Product type: Ear, nose, and throat drug administration device and contained substance. Official classification: Class 1,2. An ear, nose, and throat drug administration device is one of a group of ear, nose, and throat devices intended specificallyto administer medicinal substances to treat ear, nose, and throat disorders. These instruments include the powderblower, dropper, ear wick, manual nebulizer pump, and nasal inhaler.Classification: Class 1: The device does not contain substance (liquid or other substance), Class 2: The devicecontains flushing solution, or the substance (solution, solute, powder, etc.) is used in combination with the device to achieve the intended purpose, and the aforementioned solution contained in the device or substance used in combination with the device is not regulated as a medicinal substance.

Official code: G.5300. Product type: Ear, nose, and throat examination and treatment unit. Official classification: Class 1. An ear, nose, and throat examination and treatment unit is an AC-powered device intended to support a patient during an otologic examination while providing specialized features for examination and treatment. The unit consists of a patient chair and table, drawers for equipment, suction and blowing apparatus, and receptacles for connection of specialized lights and examining instruments.

Official code: G.5350. Product type: Suction antichoke device. Official classification: Class 3. A suction antichoke device is a device intended to beused in an emergency situation to remove, by the application of suction, foreign objects that obstruct a patient's airway to prevent asphyxiation to the patient.

Official code: G.5370. Product type: Tongs antichoke device. Official classification: Class 3. A tongs antichoke device is a device that is intended to be used in an emergency situation to grasp and remove foreign objects that obstruct a patient's airway to prevent asphyxiation of the patient. This generic type of device includes a plastic instrumentwith serrated ends that is inserted into the airway in a blind manner to grasp and extract foreign objects, and a stainless steel forceps with spoon ends that is inserted under tactile guidance to grasp and extract foreign objects from the airway.

Official code: G.5550. Product type: Powered nasal irrigator. Official classification: Class 1. A powered nasal irrigator is an AC-powered device intended to wash the nasal cavity by means of a pressure-controlled pulsating stream of water. The device consists of a control unit and pump connected to a spray tube and nozzle.

Official code: G.5800. Product type: External nasal splint. Official classification: Class 1. An external nasal splint is a rigid or partially rigid device intended for use externally for immobilization of parts of the nose.

Official code: G.5840. Product type: Antistammering device. Official classification: Class 1. An antistammering device is a device that electronically generates a noise when activated or when it senses the user's speech and that is intended to prevent the user from hearing the sounds of his or her own voice. The device is used to minimize a user's involuntary hesitative or repetitive speech.

Official code: G.9999. Product type: Others(Ear, Nose, and Throat Devices) 1,. Official classification: Class 2,3. The products excluded from the above-classification are adopted in this classification and specified by the central competent health authority.

Official code: H.0002. Product type: Dialyzer reprocessing system. Official classification: Class 2. A hemodialysis dialyzer reprocessing system is intended to clean and disinfection of reusable dialyzers. The system may include computing system for operation.

Official code: H.0003. Product type: Urological extracorporeal shock wave therapy system. Official classification: Class 3. A urological extracorporeal shock wave therapy system is a device that can treat urology-related diseases by generating shock waves.

Official code: H.1075. Product type: Gastroenterology-urology biopsy instrument. Official classification: Class 1,2. A gastroenterology-urology biopsy instrument is a device used to remove, by cutting or aspiration, a specimen of tissue for microscopic examination. This generic type of device includes the biopsypunch, gastrointestinal mechanical biopsy instrument, suction biopsy instrument, gastro-urology biopsy needle and needle set, and nonelectric biopsy forceps. This section does not apply to biopsy instruments that have been used in other medical specialty areas or covered by biopsy instruments of relevant classification categories. Classification: (1) Class 2, (2) Class 1 for the biopsy forceps cover and the non-electric biopsy forceps.

Official code: H.1300. Product type: Ingestible telemetric gastro- intestinal capsule imaging system. Official classification: Class 2. A single-use ingestible capsule isdesigned to acquire video images during natural propulsion through the digestive system. It is specifically designed to visualize the colon for the detection of polyps. It is intended for patients who are unable to perform a complete colonoscopy even with adequate preparation and for patients who are technically unable to perform a complete colonoscopic evaluation.

Official code: H.1330. Product type: Colon Capsule Imaging System. Official classification: Class 2. A single-use ingestible capsule designed to acquire video images during natural propulsion through the digestive system. It is specifically designed to visualize the colon for the detection of polyps. It is intended for use only in patients who had anincomplete optical colonoscopy with adequate preparation, and a complete evaluation of the colon was not technically possible.

Official code: H.1400. Product type: Stomach pH electrode. Official classification: Class 1. A stomach pH electrode is a device used to measure intragastric and intraesophageal pH (hydrogen ion concentration). The pH electrode is at the end of a flexible lead which may be inserted into the esophagus or stomach through the patient's mouth. The device may include an integral gastrointestinal tube.

Official code: H.1500. Product type: Endoscope and accessories. Official classification: Class 1,2. An endoscope and accessories is a device used to provide access, illumination, andallow observation or manipulation of body cavities, hollow organs, and canals. The device consists of various rigid or flexible instruments that are inserted into bodyspaces and may include an optical system for conveying an image to the user's eye and their accessories may assist in gaining access or increase the versatility and augment the capabilities of the devices. Examples of devices that are within this generic type of device include cleaning accessories for endoscopes, photographic accessories forendoscopes, nonpowered anoscopes, binolcular attachments for endoscopes, pocket battery boxes, flexible or rigid choledochoscopes, colonoscopes, diagnostic cystoscopes, cystourethroscopes, enteroscopes, esophagogastroduodenoscopes, rigid esophagoscopes, fiberoptic illuminators for endoscopes, incandescent endoscope lamps, biliary pancreatoscopes, proctoscopes, resectoscopes, nephroscopes, sigmoidoscopes, ureteroscopes, urethroscopes, endomagnetic retrievers, cytology brushes for endoscopes, biopsy tissue forceps used with endoscopes, and lubricating jelly for transurethral surgical instruments. This section does not apply to endoscopes that havebeen used in other medical specialty areas or covered by endoscopes of relevant classification categories. Classification: (1) Class 2. (2) Class 1 for the photographic accessories for endoscope, miscellaneous bulb adapter for endoscope, binocular attachment for endoscope, eyepiece attachment for prescription lens, teaching attachment, inflation bulb, measuring device for panendoscope, photographic equipment for physiologic function monitor, special lens instrument for endoscope, smoke removal tube, rechargeable battery box, pocket battery box, bite block for endoscope, and cleaning brush for endoscope.

Official code: H.1520. Product type: Gastrointestinal Lesion Software Detection System. Official classification: Class 2. A gastrointestinal lesion software detection system is a computer-assisted detection device used in conjunction with endoscopy for the detection of abnormal lesions in the gastrointestinal tract.This device contains software to assist in image detection and may contain hardware to connect to the endoscope.

Official code: H.1620. Product type: Urodynamics measurement system. Official classification: Class 1. A urodynamics measurement system is a device used to measure volume and pressure in the urinary bladder when it isfilled through a catheter with carbon dioxide or water. The device controls the supply of carbon dioxide or water and may also record the electrical activity of the muscles associated with urination. The device system may include transducers, electronic signal conditioning and display equipment, a catheter withdrawal device to enable a urethral pressure profile to be obtained, and special catheters for urethral profilometry and electrodes for electromyography. This generic type of device includes the cystometric gas (carbon dioxide) device, the cystometric hydraulic device, and the electrical recording cystometer, but excludes any device that uses air to fill the bladder.

Official code: H.1725. Product type: Gastrointestinal motility monitoring system. Official classification: Class 2. A gastrointestinal motility monitoring system is a device used to measure peristalic activity or pressure in the stomach or esophagus by means of a probe with transducers that is introduced through the mouth into the gastrointestinal tract. The device may include signal conditioning, amplifying, and recording equipment. This generic type of device includes the esophageal motility monitor and tube, the gastrointestinal motility (electrical) system, and certain accessories, such as a pressure transducer, amplifier, and external recorder.

Official code: H.1735. Product type: Electrogastrography system. Official classification: Class 2. An electrogastrography system (EGG) is a device used to measure gastric myoelectrical activity as an aid in the diagnosis ofgastric motility disorders. The device system includes the external recorder, amplifier, skin electrodes, strip chart, cables, analytical software, and other accessories.

Official code: H.1800. Product type: Urine flow or volume measuring system. Official classification: Class 1. A urine flow or volume measuring system is a device that measures directly or indirectly the volume or flow of urine from a patient, either during the course of normal urination or while the patient is catheterized. The device may include a drip chamber to reduce the risk of retrograde bacterial contamination of the bladder and a transducer and electrical signal conditioning anddisplay equipment. This generic type of device includes the electrical urinometer, mechanical urinometer, nonelectric urinometer, disposable nonelectric urine flow rate measuring device, and uroflowmeter.

Official code: H.2050. Product type: Prostate lesion documentation system. Official classification: Class 2. A prostate lesion documentation system is a device intended for use in producing an image of the prostate as an aid in documenting prostate abnormalities previously identified during a digital rectal examination. The device uses pressure sensors and image reconstruction software to produce a prostate image that highlights regional differences in intraprostatic tissue elasticity or stiffness. The device is limited to use as a documentation tool and is not intended for diagnostic purposes or for influencing any clinical decisions.

Official code: H.3350. Product type: Penile inflatable implant. Official classification: Class 3. A penile inflatable implant is a device that consists of two inflatable cylinders implanted in the penis, connected to a reservoir filled with radiopaque fluid implanted in the abdomen, and a subcutaneous manual pump implanted in the scrotum. When the cylinders are inflated, they provide rigidity to the penis. This device is used in the treatment of erectile impotence.

Official code: H.3630. Product type: Penile rigidity implant. Official classification: Class 2. A penile rigidity implant is a device that consists of a pair of semi-rigid rods implanted in the corpora cavernosa of the penis to provide rigidity. It is intended to be used in men diagnosed as having erectile dysfunction.

Official code: H.3750. Product type: Testicular prosthesis. Official classification: Class 3. A testicular prosthesis is an implanted device that consists of a solid or gel-filled silicone rubber prosthesis that is implanted surgically to resemble a testicle.

Official code: H.4020. Product type: Fiberoptic light ureteral catheter. Official classification: Class 2. A fiberoptic light ureteral catheter is a device that consists of a fiberoptic bundle that emits lightthroughout its length and is shaped so that it can be inserted into the ureter to enable the path of the ureter to be seen during lower abdominal or pelvic surgery.

Official code: H.4270. Product type: Colostomy rod. Official classification: Class 2. A colostomy rod is a device used during the loop colostomy procedure. A loop of colon is surgically brought out through the abdominal wall and the stiff colostomy rod is placed through the loop temporarily to keep the colon from slipping back through the surgical opening.

Official code: H.4300. Product type: Endoscopic electrosurgical unit and accessories. Official classification: Class 2. An endoscopic electrosurgical unit and accessories is a device used to perform electrosurgical procedures through an endoscope. This generic type of device includes the electrosurgical generator, patient plate, electric biopsy forceps, electrode, flexible snare, electrosurgical alarm system, electrosurgical power supply unit, electrical clamp, self-opening rigid snare, flexible suction coagulator electrode, patient return wristlet, contact jelly, adaptor to the cord for transurethral surgical instruments, the electric cord for transurethral surgical instruments, and the transurethral desiccator.

Official code: H.4370. Product type: Gastroenterology -urology evacuator. Official classification: Class 1,2. A gastroenterology-urology evacuator is a device used to remove debris and fluids during gastroenterologicaland urological procedures by drainage, aspiration, or irrigation. This generic type of device includes the fluid evacuator system, manuallypowered bladder evacuator, and the AC-powered vacuum pump. Classification: (1) Class 2 devices for the gastroenterology-urology evacuator when other than manually powered;(2) Class 1 devices for the gastroenterology-urology evacuator when manually powered.

Official code: H.4400. Product type: Hemorrhoidal ligator. Official classification: Class 2. A hemorrhoidal ligator is a device used to cut off the blood flow to hemorrhoidal tissue by means of a ligature or band placed around the hemorrhoid.

Official code: H.4480. Product type: Electrohydraulic lithotriptor. Official classification: Class 2. An electrohydraulic lithotriptor is an AC-powered device used to fragment urinary bladder stones. It consists of a high voltage source connected by acable to a bipolar electrode that is introduced into the urinary bladder through a cystoscope. The electrode is held against the stone in a water-filled bladder and repeated electrical discharges between the two poles of the electrode cause electrohydraulic shock waves which disintegrate the stone.

Official code: H.4500. Product type: Mechanical lithotriptor. Official classification: Class 2. A mechanical lithotriptor is a device with steel jaws that is inserted into the urinary bladder through the urethra to graspand crush bladder stones.

Official code: H.4530. Product type: Gastroenterolgy-urology fiberoptic retractor. Official classification: Class 1. A gastroenterology-urology fiberoptic retractor is a device that consists of a mechanical retractor with a fiberoptic light system that is used to illuminate deep surgical sites.

Official code: H.4560. Product type: Ribdam. Official classification: Class 1. A ribdam is a device that consists of a broad strip of latex with supporting ribs used to drain surgical wounds where copious urine drainage is expected.

Official code: H.4590. Product type: Interlocking urethral sound. Official classification: Class 1. An interlocking urethral sound is a device that consists of two metal sounds (elongated instruments for exploring or sounding body cavities) with interlocking ends, such as with male and female threads or a rounded point and mating socket, used in the repair of a ruptured urethra. The device may include a protective cap to fit over the metal threads.

Official code: H.4620. Product type: Ureteral stent. Official classification: Class 2. A ureteral stent is a tube-like implanted device that is inserted into the ureter to provide ureteral rigidity and allow the passage of urine. The device may have finger-like protrusions or hooked ends to keep the tube in place.It is used in the treatment of ureteral injuries and ureteral obstruction.

Official code: H.4650. Product type: Water jet renal stone dislodger system. Official classification: Class 1. A water jet renal stone dislodger system is a device used to dislodge stones from renal calyces (recesses of the pelvis of the kidney) by means of a pressurized stream of water through a conduit. The device is used in the surgical removal of kidney stones.

Official code: H.4680. Product type: Ureteral stone dislodger. Official classification: Class 1. A ureteral stone dislodger is a device that consists of a bougie or a catheter with an expandable wire basket near the tip, a special flexible tip, or other special construction. It is inserted through a cystoscope and used to entrap and remove stones from the ureter. This generic type of device includes the metal basket and the flexible ureteral stone dislodger.

Official code: H.4730. Product type: Manual gastroenterolgoy- urology surgical instrument and accessories. Official classification: Class 1. A manual gastroenterology-urology surgical instrument and accessories is a device designed to be used for gastroenterological and urological surgical procedures. The device may be nonpowered, hand-held, or hand-manipulated. Manual gastroenterology- urology surgical instruments include the biopsy forceps cover, biopsy tray without biopsy instruments, line clamp, nonpowered rectal probe, nonelectrical clamp, colostomy spur-crushers, locking device for intestinal clamp, needle holder, gastro-urology hook, gastro-urology probe and director, nonself-retaining retractor, laparotomy rings, nonelectrical snare, rectal specula, bladder neck spreader, self-retaining retractor, and scoop.

Official code: H.4770. Product type: Urethrotome. Official classification: Class 2. A urethrotome is a device that is inserted into the urethra and used to cut urethral strictures and enlarge the urethra. It is a metal instrument equipped with a dorsal-fin cutting blade which can be elevated from its sheath. Some urethrotomes incorporate an optical channel for visual control.

Official code: H.4890. Product type: Urological table and accessories. Official classification: Class 1,2. A urological table and accessories is a device that consists of a table, stirrups, and belts used to support a patient in a suitable position for endoscopic procedures of the lower urinary tract. The table can be adjusted into position manually or electrically. Classification: (1) Class 2 devices for the electrically powered urological table and accessories;(2) Class 1 devices for the manually powered table and accessories, and for stirrups for electrically powered table.

Official code: H.5010. Product type: Biliary catheter and accessories. Official classification: Class 2. A biliary catheter and accessories is a tubular flexible device used for temporary or prolonged drainage of the biliary tract, for splinting of the bile duct during healing, or for preventing stricture of the bile duct. This generic type of device may include a bile collecting bag that is attached to the biliary catheter by a connector and fastened to the patient with a strap.

Official code: H.5015. Product type: Pancreatic drainage stent. Official classification: Class 2. A pancreatic drainage stent is a device that consists of a self-expanding, covered, metallic stent, intended for placement to facilitate transmural endoscopic drainage of pancreatic pseudocysts. This stent is intended to be removed upon confirmation of pseudocyst resolution. This device may also include a delivery system.

Official code: H.5020. Product type: External penile rigidity devices. Official classification: Class 2. External penile rigidity devices are devices intended to create or maintain sufficient penile rigidity for sexual intercourse. External penile rigidity devices include vacuum pumps, constriction rings, and penile splints which are mechanical, powered, or pneumatic devices.

Official code: H.5025. Product type: Vibrator for climax control of premature ejaculation. Official classification: Class 2. A vibrator for climax control of premature ejaculation is used for males who suffer from premature ejaculation. It is designed to increase the time between arousal and ejaculation using the stimulating vibratory effects of the device on the penis.

Official code: H.5030. Product type: Continent ileostomy catheter. Official classification: Class 1. A continent ileostomy catheter is a flexible tubular device used as a form during surgery for continent ileostomy and it provides drainage after surgery. Additionally, the device may be inserted periodically by the patient for routine care to empty the ileal pouch. This generic type of device includes the rectal catheter for continent ileostomy.

Official code: H.5090. Product type: Suprapubic urological catheter and accessories. Official classification: Class 1,2. A suprapubic urological catheter and accessories is a flexible tubular device that is inserted through the abdominal wall into the urinary bladder with the aid of a trocar and cannula. The device is used to pass fluids to and from the urinary tract. This generic type of device includes the suprapubic catheter and tube, Malecot catheter, catheter punch instrument,suprapubic drainage tube, and the suprapubic cannula and trocar. Classification: (1) Class 2;(2)Class 1 devices for the catheter punch instrument, nondisposable cannula and trocar, and gastro-urological trocar.

Official code: H.5130. Product type: Urological catheter and accessories. Official classification: Class 1,2. A urological catheter and accessories is a flexible tubular device that is inserted through the urethra and used to pass fluids to or from the urinary tract. This generic type of device includes radiopaque urological catheters, ureteral catheters, urethral catheters, coudecatheters, balloon retention type catheters, straight catheters, upper urinary tract catheters, double lumen female urethrographic catheters, disposable ureteral catheters, male urethrographic catheters, and urological catheter accessories including ureteral catheter stylets, ureteral catheter adapters, ureteral catheter holders, ureteral catheter stylets, ureteral catheterization trays, and the gastro-urological irrigation tray (for urological use). Classification: (1) Class 2;(2) Class 1 devices for the ureteral stylet (guidewire), stylet for gastrourological catheter, ureteral catheter adapter, ureteral catheter connector, and ureteral catheter holder.

Official code: H.5140. Product type: Urethral insert with pump for bladder drainage. Official classification: Class 2. A urethral insert with pump for bladder drainage is a catheter-like device with internal pump mechanism that is placed in the urethra. Under patient control the internal pump draws urine out of the bladder when voiding is desired, and blocks urine flow when continence is desired. The device is intended for use by women who cannot empty their bladder due to impaired detrusor contractility.

Official code: H.5160. Product type: Urological clamp for males. Official classification: Class 1. A urological clamp for males is a device used to close the urethra of a male to control urinary incontinence or to hold anesthetic or radiography contrast media in the urethra temporarily. It is an external clamp.

Official code: H.5210. Product type: Enema kit. Official classification: Class 1. An enema kit is a device intended to instill water or other fluids into the colon through a nozzle inserted into the rectum to promote evacuation of the contents of the lower colon. The device consists of a container for fluid connected to the nozzle either directly or via tubing. This device does not include the colonic irrigation system (H.5220).

Official code: H.5220. Product type: Colonic irrigation system. Official classification: Class 2,3. A colonic irrigation system is a device intended to instill water into the colon through a nozzle inserted into the rectum tocleanse (evacuate) the contents of the lower colon. The system is designed to allow evacuation of the contents of the colon during the administration of the colonic irrigation. The device consists of a container for fluid connected to the nozzle via tubing andincludes a system which enables the pressure, temperature, or flow of water through the nozzle to be controlled. The device may include a console-type toilet and necessary fittings to allow the device to be connected to water and sewer pipes. The device may use electrical power to heat the water. The device does not include the enema kit (H.5210). Classification: (1) Class2 devices intended for colon cleansing when medically indicated, such as before radiological or endoscopic examinations;(2)Class 3 devices intended for other uses, including colon cleansing routinely for general well being.

Official code: H.5250. Product type: Urine collector and accessories. Official classification: Class 1,2. (a)A urine collector and accessories is a device intended to collect urine. The device and accessories consist of tubing, a suitable receptacle, connectors, mechanical supports, and may include a means to prevent the backflow of urine or ascentof infection. The two kinds of urine collectors are:(1) A urine collector and accessories intended to be connected to an indwelling catheter, which includes the urinary drainage collection kit and the closed urine drainage system and drainage bag. (2) A urine collector and accessories not intended to be connected to an indwelling catheter, which includes the corrugated rubber sheath, pediatric urine collector, leg bag for external use, urosheath type incontinence device, and the paste-on device for incontinence. (b)Classification: (1) Class 2 for a urine collector and accessories intended to be connected to an indwelling catheter;(2) Class 1 for a urine collector and accessories not intended to be connected to an indwelling catheter.

Official code: H.5270. Product type: Implanted electrical urinary continence device. Official classification: Class 3. An implanted electrical urinary device is a device intended for treatment of urinary incontinence that consists of a receiver implanted in the abdomen with electrodes for pulsed-stimulation that are implanted either in thebladder wall or in the pelvic floor, and a battery-powered transmitter outside the body.

Official code: H.5280. Product type: Implanted mechanical/hydraulic urinary continence device. Official classification: Class 3. An implanted mechanical/hydraulic urinary continence device is a device used to treat urinary incontinence by the application of continuous or intermittent pressure to occlude the urethra. The totally implanted device may consist of a static pressure pad, or a system with a container of radiopaque fluid in the abdomen and a manual pump and valve under the skin surface that is connected by tubing to an adjustable pressure pad or to a cuff around the urethra. The fluid is pumped as needed from the container toinflate the pad or cuff to pass on the urethra.

Official code: H.5310. Product type: Nonimplanted, peripheral. Official classification: Class 2. A nonimplanted, peripheral electrical continence device is a device that consists of an electrode that is connected by an electrical electrical continence devicecable to a battery-powered pulse source. The electrode is placed onto or inserted into the body at a peripheral location and used to stimulate the nerves associated with pelvic floor function to maintain urinary continence. When necessary, the electrode maybe removed by the user.

Official code: H.5320. Product type: Nonimplanted electrical continence device. Official classification: Class 2. A nonimplanted electrical continence device is a device that consists of a pair of electrodes on a plug or a pessary that are connected by an electrical cable to a powered pulse source. The plug or pessary is inserted into the rectum or into the vagina and usedto stimulate the musclesof the pelvic floor to maintain urinary or fecal continence. When necessary, the plug or pessary may be removed by the user. This classification excludes an AC-powered nonimplanted electrical continence device and the powered vaginal muscle stimulator for therapeutic use (L.5940).

Official code: H.5365. Product type: Esophageal dilator. Official classification: Class 2. An esophageal dilator is a device that consists of a cylindrical instrument that may be hollow and weighted with mercury or a metal olive-shaped weight that slides on a guide, such as a string or wireand is used to dilate a stricture of the esophagus. This generic type of device includes esophageal or gastrointestinal bougies and the esophageal dilator (metal olive).

Official code: H.5450. Product type: Rectal dilator. Official classification: Class 1. A rectal dilator is a device designed to dilate the anal sphincter and canal when the size of the anal opening may interfere with its function or the passage of an examining instrument.

Official code: H.5470. Product type: Ureteral dilator. Official classification: Class 2. A ureteral dilator is a device that consists of a specially shaped catheter or bougie and is used to dilate the ureter at the place where a stone has become lodged or to dilate a ureteral stricture.

Official code: H.5520. Product type: Urethral dilator. Official classification: Class 1,2. A urethral dilator is a device that consists of a slender hollow or solid instrument made of metal, plastic, or other suitable material in a cylindrical form and in a range of sizes and flexibilities. The device may include a mechanism to expand the portion ofthe device in the urethra and indicate the degree of expansion on a dial. It is used to dilate the urethra. This generic typeof device includes the mechanical urethral dilator, urological bougies, metal or plastic urethral sound, urethrometer, filiform, and filiform follower. Classification: (1) Class 2;(2) Class 1 for the urethrometer, urological bougie, filiform and filiformfollower, and metal or plastic urethral sound.

Official code: H.5530. Product type: Implantable transprostatic tissue retractor system. Official classification: Class 2. An implantable transprostatic tissue retractor system is a device that consists of a delivery device and implant. The delivery device is inserted transurethrally and deploys the implant through the prostate. It is designed to increase prostatic urethral patency by providing prostate lobe tissue retraction while preserving the potential for future prostate procedures and is intended for the treatment of symptoms due to urinary outflow obstruction secondary to benign prostatic hyperplasia in men.

Official code: H.5540. Product type: Blood access device and accessories. Official classification: Class 1,2. (a)A blood access device and accessories is a device intended to provide access to a patient's blood for hemodialysis or other chronic uses. When used in hemodialysis, it is part of an artificial kidney system for the treatment of patients with renal failure or toxemic conditions and provides access to a patient's blood for hemodialysis. The device includes implanted blood access devices, nonimplanted blood access devices, and accessories for both the implanted and nonimplanted blood access devices.(1) The implanted blood access device is a device and consists of various flexible or rigid tubes, such as catheters,or cannulae, which are surgically implanted in appropriate blood vessels, may come through the skin, and are intended to remain in the body for 30 days or more. This generic type of device includes various catheters, shunts, and connectors specifically designedto provide access to blood. Examples include single and double lumen catheters with cuff(s), fully subcutaneous port-catheter systems, and A-V shunt cannulae (with vessel tips). The implanted blood access device may also contain coatings or additives which may provide additional functionality to the device. (2)The nonimplanted blood access device consists of various flexible or rigid tubes, such as catheters, cannulae or hollow needles, which are inserted into appropriate blood vessels or a vascular graftprosthesis, and are intended to remain in the body for less than 30 days. This generic type of device includes fistula needles, the single needle dialysis set (coaxial flow needle), and the single needle dialysis set (alternating flow needle).(3)Accessories common to either type include the shunt adaptor, cannula clamp, shunt connector, shunt stabilizer, vessel dilator, disconnect forceps, shunt guard, crimp plier, tube plier, crimp ring, joint ring, fistula adaptor, and declotting tray (including contents). (b)Classification: (1)Class 2for the implanted blood access device;(2)Class 2 for the nonimplanted blood access device;(3) Class 2 for accessories for both the implanted and the nonimplanted blood access devices not listed in paragraph.(4)of this section.;(4)Class 1 for the cannula clamp, disconnect forceps, crimp plier, tube plier, crimp ring, and joint ring, accessories for both the implanted and nonimplanted blood access device.

Official code: H.5600. Product type: Sorbent regenerated dialysate delivery system for hemodialysis. Official classification: Class 2. A sorbent regenerated dialysate delivery system for hemodialysis is a device that is part of an artificial kidney system forthe treatment of patients with renal failure or toxemic conditions, and that consists of a sorbent cartridge and the meansto circulate dialysate through this cartridge and the dialysate compartment of the dialyzer. The device is used with the extracorporeal blood system and the dialyzer of the hemodialysis system and accessories. The device includes the means to maintain thetemperature, conductivity, electrolyte balance, flow rate and pressure of the dialysate, and alarms to indicate abnormal dialysate conditions. The sorbent cartridge may include absorbent, ion exchange and catalytic materials.

Official code: H.5630. Product type: Peritoneal dialysis system and accessories. Official classification: Class 2. (1)A peritoneal dialysis system and accessories is a device that is used as an artificial kidney system for the treatment ofpatients with renal failure or toxemic conditions, and that consists of a peritoneal access device, an administration set for peritoneal dialysis, a source of dialysate, and, in some cases, a water purification mechanism. After the dialysate is instilled into the patient's peritoneal cavity, it is allowed to dwell there so that undesirable substances from the patient's blood pass through the lining membrane of the peritoneal cavity into this dialysate. These substances are then removed when the dialysate is drained from the patient. The peritoneal dialysis system may regulate and monitor the dialysate temperature, volume, and delivery rate together with the time course of each cycle of filling, dwell time, and draining of the peritoneal cavity or manual controls may be used. This generic device includes the semiautomatic and the automatic peritoneal delivery system.(2)The peritoneal access device is a flexible tube that is implanted through the abdominal wall into the peritoneal cavity and that may have attached cuffs to provide anchoringand a skin seal. The device is either a single use peritoneal catheter, intended to remain in the peritoneal cavity for less than 30 days, or a long term peritoneal catheter. Accessories include stylets and trocars to aid in the insertion of the catheter and an obturator to maintain the patency of the surgical fistula in the abdominal wall between treatments.(3)The disposable administration set for peritoneal dialysis consists of tubing, an optional reservoir bag, and appropriate connectors. It may include a peritoneal dialysate filter to trap and remove contaminating particles.(4)The source of dialysate may be sterile prepackaged dialysate (for semiautomatic peritoneal dialysate delivery systems or "cycler systems") or dialysate prepared from dialysate concentrate and sterile purified water (for automatic peritoneal dialysate delivery systems or "reverse osmosis" systems). Prepackaged dialysate intended for use with either of the peritoneal dialysate delivery systems is regulated by FDA as a drug.

Official code: H.5665. Product type: Water purification system for hemodialysis. Official classification: Class 2. A water purification system for hemodialysis is a device that is intended for use with a hemodialysis system and that is intended to remove organic and inorganic substances and microbial contaminants from water used to dilute dialysate concentrate to form dialysate. This generic type of device may include a water softener, sediment filter, carbon filter, and water distillation system.

Official code: H.5820. Product type: Hemodialysis system and accessories. Official classification: Class 1,2. (a)A hemodialysis system and accessories is a device that is used as an artificial kidney system for the treatment of patients with renal failure or toxemic conditions and that consists of an extracorporeal blood system, a conventional dialyzer, a dialysate delivery system, and accessories. Blood from a patient flows through the tubing of the extracorporeal blood system and accessories to the blood compartment of the dialyzer, then returns through further tubing of the extracorporeal blood system to the patient. The dialyzer has two compartments that are separated by a semipermeable membrane. While the blood is in the blood compartment, undesirable substances in the blood pass through the semipermeable membrane into the dialysate in the dialysate compartment. The dialysate delivery system controls and monitors the dialysate circulating through the dialysate compartment of the dialyzer.(1) The extracorporeal blood system and accessories consists of tubing, pumps, pressure monitors, air foam or bubble detectors, and alarms to keep blood moving safely from the blood access device and accessories for hemodialysis ( H.5540) to the blood compartment of the dialyzer and back to the patient.(2) The conventional dialyzer allows a transfer of water and solutes between the blood and the dialysate through the semipermeable membrane. The semipermeable membrane of the conventional dialyzer has a sufficiently low permeability to water that an ultrafiltration controller is not required to prevent excessive loss of water from the patient's blood. This conventional dialyzer does not include hemodialyzers with the disposable inserts (Kiiltype) or dialyzers of high permeability.(3) The dialysate delivery system consists of mechanisms that monitor and control the temperature, conductivity, flow rate, and pressure of the dialysate and circulates dialysate through the dialysate compartment ofthe dialyzer. The dialysate delivery system includes the dialysate concentrate for hemodialysis (liquid or powder) and alarms to indicate abnormal dialysate conditions. This dialysate delivery system does not include the sorbent regenerated dialysate delivery system for hemodialysis (H.5600), the dialysate delivery system of the peritoneal dialysis system and accessories, or the controlled dialysate delivery system of the high permeability hemodialysis system (H.5860).(4) Remote accessories to the hemodialysis system include the unpowered dialysis chair without a scale, the powered dialysis chair without a scale, the dialyzer holder set, dialysis tie gun and ties, and hemodialysis start/stop tray. (b)Classification: (1) Class 2 for hemodialysis systems and accessories that are directly related to the extracorporeal blood system, and the dialysate delivery system;(2) Class 1 for extracorporeal blood system and dialysate delivery system that remote hemodialysis system and other accessories, such as non-powered dialysis chair, hemodialysis start/stop tray, dialyzer holder set and dialysis tie gun and ties.

Official code: H.5830. Product type: Hemodialyzer with disposable insert (kiil type). Official classification: Class 2. A hemodialyzer with disposable inserts (Kiil type) is a device that is used as a part of an artificial kidney system for the treatment of patients with renal failure or toxemic conditions.The device include multiple layers of semipermeable membranes that consists of disposable inserts (filters). It is intended to use with the extracorporeal blood systemand the dialysate delivery system of the hemodialysis system and accessories (H.5820).

Official code: H.5860. Product type: High permeability hemodialysis system. Official classification: Class 2. A high permeability hemodialysis system is a device intended for use as an artificial kidney system for the treatment ofpatients with renal failure, fluid overload, or toxemic conditions by performing such therapies as hemodialysis, hemofiltration, hemoconcentration, and hemodiafiltration. Using a hemodialyzer with a semipermeable membrane that is more permeable to water than the semipermeable membrane of the conventional hemodialysis system, the high permeability hemodialysis system removes toxins or excess fluid from the patient's blood using the principles of convection (via a high ultrafiltration rate) and/or diffusion (via a concentration gradient in dialysate). During treatment, blood is circulated from the patient through the hemodialyzer'sblood compartment, while the dialysate solution flows countercurrent through the dialysate compartment. In this process, toxins and/or fluid are transferred across the membrane from the blood to the dialysate compartment. The hemodialysis delivery machine controls and monitors the parameters related to this processing, including the rate at which blood and dialysate are pumped through the system, and the rate at which fluid is removed from the patient. The high permeability hemodialysis system consists of the following devices:(1) The hemodialyzer consists of a semipermeable membrane with an in vitro ultrafiltration coefficient (Kuf) greater than 8 milliliters per hour per conventional millimeter of mercury, as measured with bovine or expired human blood, and is used with either an automated ultrafiltration controller or anther method of ultrafiltration control to prevent fluid imbalance.(2) The hemodialysis delivery machine is similar to the extracorporeal blood system and dialysate delivery system of the hemodialysis system and accessories, with the addition of an ultrafiltration controller and mechanisms that monitor and/or control such parameters as fluid balance, dialysate composition, and patient treatment parameters (e.g., blood pressure, hematocrit, urea, etc.).(3) The high permeability hemodialysis system accessories include, but are not limited to, tubing lines and various treatment related monitors (e.g., dialysate pH, blood pressure, hematocrit, blood recirculation monitors, etc.).

Official code: H.5870. Product type: Sorbenthemoperfusion system. Official classification: Class 3. A sorbent hemoperfusion system is a device that consists of an extracorporeal blood system similar to thatidentified in the hemodialysis system and accessories and a container filled with adsorbent material that removes a wide range of substances, both toxic and normal, from blood flowing through it. The adsorbent materials are usually activated-carbon or resins which may be coated or immobilized to prevent fine particles entering the patient's blood. The generic type of device may include lines and filters specifically designed to connect the device to the extracorporeal blood system. The device is used in thetreatment of poisoning, drug overdose, hepatic coma, or metabolic disturbances.

Official code: H.5880. Product type: Isolated kidney perfusion and transport system and accessories. Official classification: Class 2. An isolated kidney perfusion and transport system and accesssories is a device that is used to supporta donated or a cadaver kidney and to maintain the organ in a near-normal physiologic state until it is transplanted into a recipient patient. This generic type of device may include tubing, catheters, connectors, an ice storage or freezing container withor without bag or preservatives, pulsatile or nonpulsatile hypothermic isolated organ perfusion apparatus with or without oxygenator, and disposable perfusion set.The item includes the preservation solutions for organs. This item is not intended for organperfusion and delivery systems use in other specialties.

Official code: H.5885. Product type: Tissue culture media for human ex vivo tissue and cell culture processing applications. Official classification: Class 2. Tissue culture media for human ex vivo tissue and cell culture processing applications consist of cell and tissue culture media and components that are composed of chemically defined components (e.g., amino acids, vitamins, inorganic salts, etc.) that are essential for the ex vivo development, survival, and maintenance of tissues and cells of human origin. The solutions are indicated for use in human ex vivo tissue and cell culture processing applications.

Official code: H.5895. Product type: Ostomy irrigator. Official classification: Class 2. An ostomy irrigator is a device that consists of a container for fluid, tubing with a cone-shaped tip or a soft and flexiblecatheter with a retention shield and that is used to wash out the colon through a colostomy, a surgically created opening of the colonon the surface of the body.

Official code: H.5900. Product type: Ostomy pouch and accessories. Official classification: Class 1. An ostomy pouch and accessories is a device that consists of a bag that is attached to the patient's skin by an adhesive material and that is intended for use as a receptacle for collection of fecal material or urine following an ileostomy, colostomy, or ureterostomy (a surgically created opening of the smallintestine, large intestine, or the ureter on the surface of the body). This generic type of device and its accessories includes the ostomy pouch, ostomy adhesive, the disposable colostomy appliance, ostomy collector, colostomy pouch, urinary ileostomy bag, urine collecting ureterostomy bag, ostomy drainage bag with adhesive, stomal bag, ostomy protector, and the ostomy size selector, but excludes ostomy pouches which incorporate arsenic-containing compounds.

Official code: H.5930. Product type: Rectal control system. Official classification: Class 2. A rectal controlsystem is a device intended to treat fecal incontinence by controlling the size of the rectal lumen. The device is inserted in the vagina and includes a portion that expands to reduce the rectal lumen to prevent stool leakage and retracts to allow normal passage of stool. The device includes an external regulator to control the state of expansion.

Official code: H.5955. Product type: Peritoneo-venous shunt. Official classification: Class 2. A peritoneo-venous shunt is an implanted device that consists of a catheter and a pressure activated one-way valve. The catheter is implanted with one end in the peritoneal cavity and the other in a large vein. This device enables ascitic fluid in the peritoneal cavity to flow into the venous system for the treatment of intractable ascites.

Official code: H.5970. Product type: Hernia support. Official classification: Class 1. A hernia supportis a device, usually made of elastic, canvas, leather, or metal, that is intended to be placed over a hernial opening (a weakness in the abdominal wall) to prevent protrusion of the abdominal contents. This generic type of device includes the umbilical truss.

Official code: H.5980. Product type: Gastrointestinal tube and accessories. Official classification: Class 1,2. A gastrointestinal tube and accessories is a device that consists of flexible or semi-rigid tubing used for instilling fluids into, withdrawing fluids from, splinting, or suppressing bleeding of the alimentary tract. This device may incorporate an integral inflatable balloon for retention or hemostasis. This generic type of device includes the hemostatic bag, irrigation and aspiration catheter (gastric, colonic, etc.), rectal catheter, sterile infant gavage set, gastrointestinal string and tubes to locate internal bleeding, double lumen tube for intestinal decompression or intubation, feeding tube, gastroenterostomy tube, Levine tube, nasogastrictube, single lumen tube with mercury weight balloon for intestinal intubation or decompression, and gastro-urological irrigation tray (for gastrological use).Classification: (1)Class 2;(2)Class 1 for the dissolvable nasogastric feed tube guide for the nasogastric tube.

Official code: H.5990. Product type: Extracorporeal shock wave lithotripter. Official classification: Class 2. An extracorporeal shock wave lithotripter is a device that focuses ultrasonic shock waves into the body to noninvasively fragment urinary calculi within the kidney or ureter. The primary components of the device are a shock wave generator, high voltage generator, control console, imaging/localization system, and patient table. Prior to treatment, the urinary stone is targetedusing either an integral or stand-alone localization/imaging system. Shock waves are typically generated using electrostatic spark discharge (spark gap), electromagnetically repelled membranes, or piezoelectric crystal arrays, and focused onto the stone with either a specially designed reflector, dish, or acoustic lens. The shock waves are created under water within the shock wave generator, and are transferred to the patient's body using an appropriate acoustic interface. After the stone has been fragmented by the focused shock waves, the fragments pass out of the body with the patient's urine.

Official code: H.9999. Product type: Others(Gastroenterology and Urology Devices) 1,. Official classification: Class 2,3. The products excluded from the above-classification are adopted in this classification and specified by the central competent health authority.

Official code: I.0001. Product type: High density electrical current subcutaneous wrinkle reduction device. Official classification: Class 2. A devicewith high density electrical current for subcutaneous wrinkle reduction is a device applying an electrical current to electrodes on a patient's skin up to subdermal or muscle layers for reducing body wrinkles and connective tissue swelling by physical action. This device applies high density electrical current to stimulate collagen and elastin production by heating tissues in the deep layers of the skin.

Official code: I.0002. Product type: Collagen implant. Official classification: Class 3. A collagen implant is a device primarily composed of collagen to correct or be implanted in facial or other body surface where weakness exists.

Official code: I.0003. Product type: Ultrasonic surgical. Official classification: Class 2. An ultrasonic surgical instrument is a surgical device for soft tissue ablation. This device contains ultrasound generator and instrumentaccessories including control console, ultrasound applicator(s), foot switch, and waste collector.

Official code: I.0004. Product type: Alcohol pad. Official classification: Class 2. An alcohol pad is a non-absorbable piece of cotton containing alcohol used for, e.g.,skin cleaning, disinfection and medical purposes.

Official code: I.0005. Product type: Providone-Iodine pad. Official classification: Class 2. A Providone-Iodine pad is a non-absorbable piece of cotton containing Providone-Iodine used for, e.g.,skin cleaning, disinfection and medical purposes.

Official code: I.0006. Product type: Medical protective clothing. Official classification: Class 2. Medical protective clothing are devices that are intended to be worn by medical personnel in medical environments. These devices protect medical personnel from cross-infection. These devices are to protect whole or part of the body from the environments. Surgical gowns are not included in this identification. Classification: Class 2.

Official code: I.0007. Product type: Hyaluronic Acid Implants. Official classification: Class 3. Hyaluronic acid implants are hyaluronic acid substances used to modify or filled into surface defects on the face or other body positions.

Official code: I.0008. Product type: Transcutaneous skin stimulator. Official classification: Class 2. A transcutaneous skin stimulator applies energy (e.g., electrical current, optical energy, ultrasound energy, etc.) on a patient's skin up to dermal or subdermal layers to modify skin appearance (e.g., skin tightening, toning, lifting, reducing wrinkles, etc.) or to stimulate collagen or cell production.

Official code: I.0009. Product type: High Intensity Focused Ultrasound (HIFU) Ablation System. Official classification: Class 3. An high intensity focused ultrasound (HIFU) ablation system is intended to use HIFU to ablate soft tissue or specific cell tissue. The system needs to be used with medical imaging systems (e.g., MR imaging systems, etc.) used for guiding the procedure.

Official code: I.0010. Product type: Adhesion Barrier Material. Official classification: Class 3. Adhesion barrier material, which can be in the form of colloid or film, as a temporary physical barrier to separate tissues to reduce fibrosis and reduce the formation of adhesions. It can be used in general surgical sites, not in other specialty areas or theone that already has adhesion barrier materials in related categories.

Official code: I.1800. Product type: Speculum and accessories. Official classification: Class 1. A speculumis a device intended to be inserted into a body cavity to aid observation. It is either nonilluminated or illuminated and may have various accessories.

Official code: I.3250. Product type: External facial fracture fixation appliance. Official classification: Class 1. An external facial fracture fixation appliance isa metal apparatus intended to be used during surgical reconstruction and repair to immobilize maxillofacial bone fragments in their proper facial relationship.

Official code: I.3300. Product type: Surgical mesh. Official classification: Class 2. Surgical mesh is a metallic or polymeric screen intended to be implantedto reinforce soft tissue or bone where weakness exists. Examples of surgical mesh are metallic and polymeric mesh for hernia repair, and acetabular and cement restrictor mesh used during orthopedic surgery.

Official code: I.3500. Product type: Polytetrafluoroethylene with carbon fibers composite implant material. Official classification: Class 2. A polytetrafluoroethylene with carbon fibers composite implant material is a porous device material intended to be implanted during surgery of the chin, jaw, nose, or bones or tissue near the eye or ear. The device material serves as a space-occupying substance and is shaped and formed by the surgeon to conform to the patient's need.

Official code: I.3530. Product type: Silicone inflatable breast. Official classification: Class 3. A silicone inflatable breast prosthesis is a silicone rubber shell made of polysiloxane(s), suchas polydimethylsiloxane and prosthesispolydiphenylsiloxane, that is inflated to the desired size with sterile isotonic saline before or after implantation. The device is intended to be implanted to augment or reconstruct the female breast.

Official code: I.3540. Product type: Silicone gel-filledbreast prosthesis. Official classification: Class 3. (1)Single-lumen silicone gel-filled breast prosthesis. A single-lumen silicone gel-filled breast prosthesis is a silicone rubber shell made of polysiloxane(s), such as polydimethylsiloxane and polydiphenylsiloxane. The shell either contains a fixed amount cross- linked polymerized silicone gel, filler, and stabilizers or is filled to the desired size with injectable silicone gel at time of implantation. The device is intended to be implanted to augment or reconstruct the female breast. (2)Double-lumen silicone gel- filled breast prosthesis. A double lumen silicone gel-filled breast prosthesis is a silicone rubber inner shell and a silicone rubber outer shell, both shells made of polysiloxane(s), such as polydi-methylsiloxane and polydiphenylsiloxane. The inner shell contains fixed amounts of cross-linked polymerized silicone gel, fillers, and stabilizers. The outer shell is inflated to the desired size with sterile isotonic saline before or after implantation. The device is intended to be implanted to augment or reconstruct the female breast. (3)Polyurethane covered silicone gel-filled breast prosthesis. A polyurethane covered silicone gel-filled breast prosthesis is an inner silicone rubber shell made of polysiloxane(s), such as polydimethylsiloxane and polydiphenylsiloxane, with an outer silicone adhesive layer and an outer covering of polyurethane; contained within the inner shell is a fixed amount of cross-linked polymerized silicone gel, fillers, and stabilizers and an inert support structure compartmentalizing the silicone gel. The device is intended to be implanted to augment or reconstruct the female breast.

Official code: I.3550. Product type: Chin prosthesis. Official classification: Class 2. A chin prosthesis is a silicone rubber solid device intended to be implanted to augment or reconstruct the chin.

Official code: I.3590. Product type: Ear prosthesis. Official classification: Class 2. An ear prosthesis is a silicone rubber solid device intended to be implanted to reconstruct the external ear.

Official code: I.3610. Product type: Esophageal prosthesis. Official classification: Class 2. An esophageal prosthesis is a rigid, flexible, or expandable tubular devicemade of a plastic, metal, or polymeric material that is intended to be implanted to restore the structure and/or function of the esophagus. The metal esophageal prosthesis may be uncovered or covered with a polymeric material. This device may also include a device delivery system.

Official code: I.3680. Product type: Nose prosthesis. Official classification: Class 2. A nose prosthesis is a silicone rubber solid device intended to be implanted to augment or reconstruct the nasal dorsum.

Official code: I.3720. Product type: Tracheal prosthesis. Official classification: Class 2. The tracheal prosthesis is a rigid, flexible, or expandable tubular device made of a silicone, metal, or polymeric material that is intended to be implanted to restore the structure and/or function of the trachea or trachealbronchial tree. It may be unbranched or contain one or two branches. The metal tracheal prosthesis may be uncovered or covered with a polymeric material. This device may also include a device delivery system.

Official code: I.3800. Product type: External aesthetic restoration prosthesis. Official classification: Class 1. An external aesthetic restoration prosthesis is a device intended to be used toconstruct an external artificial body structure, such as an ear, breast, or nose. Usually the device is made of silicone rubber and it may be fastened to the body with an external prosthesis adhesive. The device is not intended to be implanted.

Official code: I.3900. Product type: Inflatable extremity splint. Official classification: Class 1. An inflatable extremity splint is a device intended to be inflated to immobilize a limb or an extremity.

Official code: I.3910. Product type: Noninflatable extremity splint. Official classification: Class 1. A noninflatable extremity splint is a device intended to immobilize a limb or an extremity. It is not inflatable.

Official code: I.3925. Product type: Plastic surgery kit and accessories. Official classification: Class 1. A plastic surgery kit and accessories is a device intended to be used to reconstruct maxillofacial deficiencies. The kit contains surgical instruments and materials used to make maxillofacial impressions before molding an external prosthesis.

Official code: I.4010. Product type: Tissue adhesive. Official classification: Class 2,3. (a)Tissue adhesive for the topical approximation of skin is a device intended for topical closure of surgical incisions, including laparoscopic incisions, and simple traumatic lacerations that have easily approximated skin edges. Tissue adhesives for the topical approximation of skin may be used in conjunction with, but not in place of, deep dermal stitches. Classification: Class 2. (b) A tissue adhesive for non-topical use, including adhesives intended for use in the embolization of brain arteriovenous malformation or for use in ophthalmic surgery, is a device used for adhesion of internal tissues and vessels. Classification:Class 3.

Official code: I.4011. Product type: Tissue adhesive with adjunct wound closure device for topical approximation of skin. Official classification: Class 2. A tissue adhesive with adjunct wound closure device intended for the topical approximation of skin is a device indicated fortopical application only to hold closed easily approximated skin edges of wounds from surgical incisions, including punctures from minimally invasive surgery, and simple, thoroughly cleansed, trauma-induced lacerations. It may be used in conjunction with, but not in place of, deep dermal stitches. Additionally, the adjunctwound closure device component maintains temporary skin edge alignment along the length of wound during application of the liquid adhesive..

Official code: I.4014. Product type: Nonresorbable gauze/sponge for external use. Official classification: Class 1,2. A nonresorbable gauze/sponge for external use is a sterileor nonsterile device intended for medical purposes, such as to be placed directly on a patient's wound to absorb exudate. It consists of a strip, piece, or pad made from open woven or nonwoven mesh cotton cellulose or a simple chemical derivative of cellulose. Classification: Class 1.This classification does not include a nonresorbable gauze/sponge for external use that contains added drugs such as antimicrobial agents, added biologics such as growth factors, or is composed of materials derived from animal sources. Classification: Class 2.

Official code: I.4015. Product type: Wound dressing with poly (diallyl dimethyl ammonium chloride) (pDADMAC) additive. Official classification: Class 2. A wound dressing with pDADMAC additive is intended for use as a primary dressing for exuding wounds, 1st and 2nd degree burns, and surgical wounds, to secure and prevent movement of a primary dressing, and as a wound packing.

Official code: I.4018. Product type: Hydrophilic wound dressing. Official classification: Class 1,2. A hydrophilic wound dressing is a sterile or non-sterile device intended to cover a wound and to absorb exudate. It consists of nonresorbable materials with hydrophilic properties that are capable of absorbing exudate (e.g.,cotton, cotton derivatives, alginates, dextran, and rayon). Classification: (1)Class 2 devices that are intended for patients with class 3 burning wound, free sewing(replacing surgical suture), contain added drugs such as antimicrobial agents, added biologics such as growth factors,or is composed of materials derived from animal sources.;(2)Class 1 other devices.

Official code: I.4020. Product type: Occlusive wound/burn dressing. Official classification: Class 1,2. An occlusive wound dressing is a nonresorbable, sterile or non-sterile device intended to cover a wound, to provide or support a moist wound environment, and to allow the exchange of gases such as oxygen and water vapor through the device. It consists of a piece of synthetic polymeric material, such as polyurethane, with or without an adhesive backing.Classification: (1)Class 2 devices that are intended for patients with class 3 burning wound, free sewing(replacing surgical suture), contain added drugssuch as antimicrobial agents, added biologics such as growth factors, or is composed of materials derived from animal sources.;(2)Class 1 other devices.

Official code: I.4022. Product type: Hydrogel wound dressing and burn dressing. Official classification: Class 1,2. A hydrogel wound dressing is a sterile or non-sterile device intended to cover a wound, to absorb wound exudate, to control bleeding or fluid loss, and to protect against abrasion, friction, desiccation, and contamination. It consists of a nonresorbable matrix made of hydrophilic polymers or other material in combination with water (at least 50 percent) and capable of absorbing exudate. Classification: (1)Class 2 devices that are intended for patients with class 3 burning wound, free sewing(replacing surgicalsuture), contain added drugs such as antimicrobial agents, added biologics such as growth factors, or is composed of materials derived from animal sources.;(2)Class 1 other devices.

Official code: I.4025. Product type: Silicone scar management product. Official classification: Class 1. Silicone scar management product is intended for use in the management ofclosed hyperproliferative (hypertrophic and keloid) scars.

Official code: I.4040. Product type: Medical apparel. Official classification: Class 1,2. Surgical apparel are devices that are intended to be worn by operating room personnel during surgical procedures to protect both the surgical patient and the operating room personnel from transfer of microorganisms, body fluids, and particulate material. Examples include surgical caps, hoods, masks, gowns, operating room shoes and shoe covers, and isolation masks and gowns. Surgical suits and dresses, commonly known as scrub suits, are excluded. Classification: (1) Class 2 devices intended for surgical procedure including surgical gowns and surgical masks. (2) Class 1 other devices. Medical masks are required to meet performance requirements from the national standard CNS 14774(T5017). For medical masks that are labelled/claimed to have the equivalent or above effect of TN95 or N95, the sub-micron particulate filtration efficiency and exhalation/inhalation resistance of airflow (replacing “differential pressure” test) of the mask should be in accordance with TN95 class (or higher) performance requirements from disposable dust-proof masks of the national standard CNS 14755 (Z2125).

Official code: I.4100. Product type: Organ bag. Official classification: Class 1. An organ bag is a device that is a flexible plastic bag intended to beused as a temporary receptacle for an organ during surgical procedures to prevent moisture loss.

Official code: I.4160. Product type: Surgical camera and accessories. Official classification: Class 1. A surgical camera and accessories is a device intended to be used to record operative procedures.

Official code: I.4165. Product type: Wound autofluorescence imaging device. Official classification: Class 2. A wound autofluorescence imaging device is a tool to view autofluorescence images from skin wounds that are exposed to an excitation light. The device is not intended to provide quantitative or diagnostic information.

Official code: I.4200. Product type: Introduction/drainage catheter and accessories. Official classification: Class 1. An introduction/drainage catheter is a device that is a flexible single or multilumen tube intended to be used to introduce nondrug fluids into body cavities other than blood vessels, drain fluids from body cavities, or evaluate certain physiologic conditions. Examples include irrigation and drainage catheters, pediatric catheters, peritoneal catheters (including dialysis), and othergeneral surgical catheters. An introduction/drainage catheter accessory is intended to aid in the manipulation of or insertion of the device into the body. Examples of accessories include adaptors, connectors, and catheter needles.

Official code: I.4300. Product type: Implantable clip. Official classification: Class 2. An implantable clip is a clip-like device intended to connect internal tissues to aid healing. It is not absorbable.

Official code: I.4320. Product type: Removable skin clip. Official classification: Class 1. A removable skin clip is a clip-like device intended to connect skin tissues temporarily to aid healing. It is not absorbable.

Official code: I.4340. Product type: Contact cooling system. Official classification: Class 2. A contact cooling system is a device that is a combination of a cooling pad associated with a vacuum or mechanical massager intended for the disruption of adipocyte cells intended for non-invasive use.

Official code: I.4350. Product type: Cryosurgical unit and accessories. Official classification: Class 2. (1)Cryosurgical unit with a liquid nitrogen cooled cryoprobe and accessories. A cryosurgical unit with a liquid nitrogen cooled cryoprobe and accessories is a device intended to destroy tissue during surgical procedures by applying extreme cold.(2)Cryosurgical unit with a nitrous oxide cooled cryoprobe and accessories. A cryosurgical unit with a nitrous oxide cooled cryoprobe and accessories is a device intended to destroy tissue during surgical procedures, including urological applications, by applying extreme cold.(3)Cryosurgical unit with a carbon dioxide cooled cryoprobe or a carbon dioxide dry ice applicator and accessories. A cryosurgical unit with a carbon dioxide cooled cryoprobe or a carbon dioxide dry ice applicator and accessories is a device intended to destroy tissue during surgical procedures by applying extreme cold. The device is intended to treat disease conditions such as tumors, skin cancers, acne scars, or hemangiomas (benign tumors consisting of newly formed blood vessels) and various benign or malignant gynecological conditions affecting vulvar, vaginal, or cervical tissue. The device is not intended for urological applications.

Official code: I.4360. Product type: Scalp cooling system to reduce the likelihood of chemotherapy-induced alopecia. Official classification: Class 2. A scalp cooling system to reduce the likelihood of chemotherapy-induced alopecia is a device intended to reduce the frequency and severity of alopecia during chemotherapy in which alopecia-inducing chemotherapeutic agents are used.

Official code: I.4370. Product type: Surgical drape and drape accessories. Official classification: Class 1,2. (a) A surgical drape and drape accessories is a device made of natural or synthetic materials intended to be used as a protective patient covering, such as to isolate a site of surgical incision from microbial and other contamination. The device includesa plastic wound protector thatmay adhere to the skin around a surgical incision or be placed in a wound to cover its exposed edges, and a latex drape with a self-retaining finger cot that is intended to allow repeated insertion of the surgeon's finger into the rectum during performance of a transurethral prostatectomy. (b) Classification: (1) Class 2. (2) Class 1 for drape and cover intended for medical device covering.

Official code: I.4371. Product type: Irrigating wound retractor device. Official classification: Class 2. An irrigating wound retractor device is a device intended to be used bya surgeon to retract the surgical incision, to provide access to the surgical wound, to protect and irrigate the surgical wound, and to serve as a conduit for removal of fluid from the surgical wound.

Official code: I.4380. Product type: Drape adhesive. Official classification: Class 1. A drape adhesive is a device intended to be placed on the skin to attach a surgical drape.

Official code: I.4400. Product type: Electrosurgical cutting and coagulation device and accessories. Official classification: Class 2. An electrosurgical cutting and coagulation device and accessories is a device intended to remove tissue and control bleeding by use of high-frequency electrical current.

Official code: I.4410. Product type: Low energy ultrasound wound cleaner. Official classification: Class 2. A low energy ultrasound wound cleaner is a device that uses ultrasound energy to vaporize a solution and generate a mist thatis used for the cleaning and maintenance debridement of wounds. Low levels of ultrasound energy may be carried to the wound by the saline mist.

Official code: I.4440. Product type: Eye pad. Official classification: Class 1. An eye pad is a device that consists of a pad made of various materials, such as gauze and cotton, intended for use as a bandage over the eye for protection or absorption of secretions.

Official code: I.4450. Product type: Nonabsorbable gauze for internal use. Official classification: Class 1. Nonabsorbable gauze for internal use is a device made of an open mesh fabric intended to be used inside the body or a surgical incision or applied to internal organs or structures, to control bleeding, absorb fluid, or protect organs or structures from abrasion, drying, or contamination. The device is woven from material made of not less than 50 percent by mass cotton, cellulose, or a simple chemical derivative of cellulose, and contains x-ray detectable elements.

Official code: I.4454. Product type: Non-absorbable, hemostatic gauze for temporary internal use. Official classification: Class 2. A non-absorbable , hemostatic gauze for temporary internal use is a device intended to be placed temporarily for control of severely bleeding wounds such as surgical wounds and traumatic injuries. The gauze is coated or impregnated with a hemostatic material which may enhance hemostasis by physical means. The device is intended to be removed once the patient is stabilized.

Official code: I.4460. Product type: Surgeon's glove. Official classification: Class 1,2. A surgeon's glove is a device made of natural or synthetic rubber intended to be worn by operating room personnel to protecta surgical wound from contamination. The lubricating or dusting powder used in the glove is excluded. A surgeon's glove containing biodegradable powders which complies with U.S.P. (for example corn powders) is class 2 device. Non-clinical performance data of the barrier property (water leak) and tensile strength should comply with ISO 10282, ASTM D 3577, EN 455 or equivalent standards. A non-powdered (powder free) surgeon's glove should comply with EN ISO 21171, ASTM D 6124 or equivalent standards. The average amount of residual powders on a glove should not exceed 2.0 mg.

Official code: I.4470. Product type: Surgeon's gloving cream. Official classification: Class 1. Surgeon's gloving cream is an ointment intended to be used to lubricate the user's hand before putting on a surgeon's glove.

Official code: I.4480. Product type: Absorbable powder for lubricating a surgeon's glove. Official classification: Class 3. Absorbable powder for lubricating a surgeon's glove is a powder made from corn starch that meets the specifications for absorbable powder in the United States Pharmacopeia (U.S.P.) and that is intended to be used to lubricate the surgeon's hand before putting on a surgeon's glove. The device is absorbable through biological degradation.

Official code: I.4490. Product type: Absorbable hemostatic agent and dressing. Official classification: Class 3. An absorbable hemostatic agent or dressing is a device intended to produce hemostasis by accelerating the clotting process of blood. It is absorbable.

Official code: I.4493. Product type: Absorbable poly (glycolide/L-lactide) surgical suture. Official classification: Class 2. An absorbable poly(glycolide/l-lactide) surgical suture (PGL suture) is an absorbable sterile, flexible strand as prepared and synthesized from homopolymers of glycolide and copolymers made from 90 percent glycolide and 10 percent L-lactide, and is indicated for use in soft tissue approximation. It may be monofilament or multifilament (braided) in form; it may be uncoatedor coated; and it may be undyed or dyed with an FDA-approved color additive. Also, the suture may be provided with or without a standard needle attached.

Official code: I.4494. Product type: Absorbable poly(hydroxybutyrate) surgical suture produced by recombinant DNA. Official classification: Class 2. An absorbable poly(hydroxybutyrate) surgical suture is an absorbable surgical suture made of material isolated from prokaryotic cells produced by recombinant deoxyribonucleic acid (DNA) technology. The device is intended for use in general soft tissue approximation and ligation. Also, the suture may be provided with or without a standard needle attached. technology

Official code: I.4495. Product type: Stainless steel suture. Official classification: Class 2. A stainless steel suture is a needled or unneedled nonabsorbable surgical suture composed of 316L stainless steel, in USP sizes 12- 0 through 10, or a substantially equivalent stainless steel suture, intended for use in abdominal wound closure, intestinal anastomosis, hernia repair, and sternal closure.

Official code: I.4520. Product type: Polytetrafluoroethylene injectable. Official classification: Class 3. Polytetrafluoroethylene injectable is an injectable paste prosthetic device composed of polytetrafluoroethylene intended to be used to augment or reconstruct a vocal cord.

Official code: I.4580. Product type: Surgical lamp. Official classification: Class 2. A surgical lamp (including a fixture) is a device intended to be used to provide visible illumination of the surgical field or the patient.

Official code: I.4590. Product type: Focused ultrasound stimulator system. Official classification: Class 2. A Focused Ultrasound Stimulator System is a device using focused ultrasound to produce localized, mechanical motion within tissues and cells for the purpose of producing either localized heating for tissue coagulation or for mechanical cellular membrane disruption intended for noninvasive use.

Official code: I.4630. Product type: Ultraviolet lamp for dermatologic disorders. Official classification: Class 2. An ultraviolet lamp for dermatologic disorders is a device (including a fixture) intended to provide ultraviolet radiation ofthe body to photoactivate a drug in the treatment of a dermatologic disorder if the labeling of the drug intended for use with the device bears adequate directions for the device's use with that drug.

Official code: I.4650. Product type: Aorto-saphenous vein ostia marker. Official classification: Class 2. An Aorto-saphenous vein ostia marker is used as a landmark to identify the anastomosis site of the vein utilizing fluorscopy. The marker is surgically attached to a anastomosis sites of the vein graft.

Official code: I.4660. Product type: Skin marker. Official classification: Class 1. A skin marker is a pen-like device intended to be used to write on the patient's skin, e.g., to outline surgical incision sites or mark anatomical sites for accurate blood pressure measurement.

Official code: I.4670. Product type: Internal tissue marker. Official classification: Class 2. An internal tissue marker is a use device that is intended for use prior to or during general surgical procedures to demarcate selected sites on internal tissues.

Official code: I.4680. Product type: Nonpowered, single patient, portable suction apparatus. Official classification: Class 1. A nonpowered, single patient, portable suction apparatus is a device that consists of a manually operated plastic, disposable evacuation system intended to provide a vacuum for suction drainage of surgical wounds.

Official code: I.4683. Product type: Non-Powered suction apparatus device intended for negative pressure wound therapy. Official classification: Class 2. A non-powered suction apparatus device intended for negative pressure wound therapy is a device that is indicated for wound management via application of negative pressure to the wound for removal of fluids, including wound exudate, irrigation fluids, and infectious materials. It is further indicated for management of wounds, burns, flaps, and grafts.

Official code: I.4685. Product type: Extracorporeal shock wave device for treatment of chronic wounds. Official classification: Class 3. An extracorporeal shock wave device for treatment of chronic wounds is a device that focuses acoustic shock waves onto the dermal tissue. The shock waves are generated inside the device and transferred to the body using an acoustic interface.

Official code: I.4700. Product type: Surgical microscope and. Official classification: Class 1. A surgical microscope and accessories is an AC-powered device intended for use during surgery to provide a magnified view of accessoriesthe surgical field.

Official code: I.4730. Product type: Surgical skin degreaser or adhesive tape solvent. Official classification: Class 1. A surgical skin degreaser or an adhesive tape solvent is a device that consists of a liquid such as 1,1,2-trichloro-1,2,2- trifluoroethane; 1,1,1-trichloroethane; and 1,1,1-trichloroethane with mineral spirits intended to be used to dissolve surface skin oil or adhesive tape.

Official code: I.4750. Product type: Implantable staple. Official classification: Class 2. An implantable staple is a staple-like device intended to connect internal tissues to aid healing. It is not absorbable.

Official code: I.4760. Product type: Removable skin staple. Official classification: Class 1. A removable skin staple is a staple-like device intended to connect external tissues temporarily to aid healing. It is not absorbable.

Official code: I.4780. Product type: Powered suction pump. Official classification: Class 2. A powered suction pump is a portable, AC-powered or compressed air-powered device intended to be usedto remove infectious materials from wounds or fluids from a patient's airway or respiratory support system. The device may be used during surgeryin the operating room or at the patient's bedside. The device may include a microbial filter.

Official code: I.4800. Product type: Manual surgical instrument for general use. Official classification: Class 1. A manual surgical instrument for general use is a nonpowered, hand-held, or hand-manipulated device, either reusable or disposable, intended to be used in various general surgical procedures. The device includes the applicator, clip applier, biopsy brush, manual dermabrasion brush, scrub brush, cannula, ligature carrier, chisel, clamp, contractor, curette, cutter, dissector, elevator, skin graft expander, file, forceps, gouge, instrument guide, needle guide, hammer, hemostat, amputation hook, ligature passing and knot-tying instrument, knife, blood lancet, mallet, disposable or reusable aspiration and injectionequipment, disposable or reusable suturing needle, osteotome, pliers, rasp, retainer, retractor, saw, scalpel blade, scalpel handle, one-piece scalpel, snare, spatula, stapler, disposable or reusable stripper, stylet, suturing apparatus for the stomach and intestine,measuring tape, and calipers. A surgical instrument that has specialized uses in a specific medicalspecialty is classified in separate regulations in parts D through P.

Official code: I.4810. Product type: Laser surgical instrument for use in general and plastic surgery and in dermatology. Official classification: Class 2. A laser device for use in general surgery, plastic surgery and dermatology is a laser deviceintended to cut, destroy, or remove tissue by light energy.

Official code: I.4815. Product type: Magnetic surgical instrument system. Official classification: Class 2. A magnetic surgical instrument system is a device used in laparoscopic surgical procedures consisting of several components,such as surgical instruments, and a magnetic controller. The magnetic controller is provided separately from the surgical instrument and is used outside the patient. The external magnetic controller is magnetically coupled with the internal surgical instrument(s) at the surgical site to grasp, hold, retract, mobilize, or manipulate soft tissue and organs.

Official code: I.4820. Product type: Surgical instrument motors and accessories/attachments. Official classification: Class 1. Surgical instrument motors and accessories/attachments are AC-powered, battery-powered, or air-powered devices intended for use during surgical procedures to provide power to operate various accessories or attachments to cut hard tissue or bone andsoft tissue. Accessories or attachments may include a bur, chisel (osteotome), dermabrasion brush, dermatome, drill bit,hammerhead, pin driver, and saw blade. This item not suitable for devices used for skull and spine surgery.

Official code: I.4830. Product type: Absorbable surgical gut suture. Official classification: Class 2. An absorbable surgical gut suture, both plain and chromic, is an absorbable, sterile, flexible thread prepared from either the serosal connective tissue layer of beef (bovine) or the submucosal fibrous tissue of sheep (ovine) intestine, and is intended for usein soft tissue approximation.

Official code: I.4840. Product type: Absorbable polydioxanone surgical suture. Official classification: Class 2. An absorbable polydioxanone surgical suture is an absorbable, flexible, sterile, monofilament thread prepared from polydioxanone and is intended for use in soft tissue approximation, including pediatric cardiovascular tissue where growth is expected to occur, and ophthalmic surgery. It may be coated or uncoated, undyed or dyed, and with or without a standard needle attached.

Official code: I.4930. Product type: Suture retention device. Official classification: Class 1. A suture retention device is a device, such as a retention bridge, a surgical button, or a suture bolster, intended to aid wound healing by distributing suture tension over a larger area in the patient.

Official code: I.4950. Product type: Manual operating table and accessories and manual operating chair and accessories. Official classification: Class 1. A manual operating table and accessories and a manual operating chair and accessories are nonpowered devices, usually with movable components, intended to be used to support a patient during diagnostic examinations or surgical procedures.

Official code: I.4960. Product type: Operating tables and accessories and operating chairs and accessories. Official classification: Class 1. Operating tables and accessories and operating chairs and accessories are AC-powered or air-powered devices, usually with movable components, intended for use during diagnostic examinations or surgical procedures to support and position a patient.

Official code: I.5000. Product type: Nonabsorbable poly(ethylene terephthalate)surgical suture. Official classification: Class 2. Nonabsorbable poly(ethylene terephthalate) surgical suture is a multifilament, nonabsorbable, sterile, flexible thread prepared from fibers of high molecular weight, long-chain, linear polyesters having recurrent aromatic rings as an integral component and is indicated for use in soft tissue approximation. It may be undyed or dyed with an appropriate FDA listed color additive. Also,the suture may be provided with or without a standard needle attached.

Official code: I.5010. Product type: Nonabsorbable polypropylene surgical suture. Official classification: Class 2. Nonabsorbable polypropylene surgical suture is a monofilament, nonabsorbable, sterile, flexible thread prepared from long-chain polyolefin polymer known as polypropylene and is indicated for use in soft tissue approximation.It may be undyed or dyed with an FDA approved color additive; and the suture may be provided with or without a standard needle attached.

Official code: I.5020. Product type: Nonabsorbable polyamide surgical suture. Official classification: Class 2. Nonabsorbable polyamide surgical suture is a nonabsorbable, sterile, flexible thread prepared from long-chain aliphatic polymers Nylon 6 and Nylon 6,6 and is indicated for use in soft tissue approximation. It may be provided uncoated or coated; and it may be undyed or dyed with an appropriate FDA listed color additive. Also, the suture may be provided with or without a standard needle attached.

Official code: I.5030. Product type: Natural nonabsorbable silk surgical suture. Official classification: Class 2. Natural nonabsorbable silk surgical suture is a nonabsorbable, sterile, flexible multifilament thread composed of an organic protein called fibroin. This protein is derived from the domesticated species Bombyx mori (B. mori ) of the familyBombycidae. Natural nonabsorbable silk surgical suture is indicated for use in soft tissue approximation. Natural nonabsorbable silk surgical suture may be braided or twisted; it may be provided uncoated or coated; and it may be undyed or dyed with an FDA listed color additive. Also, the suture may be provided with or without a standard needle attached.

Official code: I.5035. Product type: Nonabsorbable expanded polytetrafluoroethylene. Official classification: Class 2. Nonabsorbable expanded polytetrafluoroethylene (ePTFE) surgical suture is a monofilament, nonabsorbable, sterile, flexible thread prepared from ePTFE and is intended for use in soft tissue approximation and ligation,including cardiovascular surgery. It surgical suturemay be undyed or dyed with an approved color additive and may be provided with or without an attached needle(s).

Official code: I.5040. Product type: Suction lipoplasty system. Official classification: Class 2. A suction lipoplasty system is a device intended for aesthetic body contouring. The device consists of a powered suction pump (containing a microbial filter on the exhaust and a microbial in-line filter in the connecting tubing between the collection bottle and the safety trap), collection bottle, cannula, and connecting tube. The microbial filters, tubing, collection bottle, and cannula must be capable of being changed between patients. The powered suction pump has a motor with a minimum of 1/3 horsepower, a variable vacuum range from 0 to 29.9 inches of mercury, vacuum control valves to regulate the vacuum with accompanying vacuum gauges, a single or double rotary vane (with or without oil), a single or double diaphragm, a single or double piston,and a safety trap.

Official code: I.5070. Product type: Air-handling apparatus for a surgical operating room. Official classification: Class 2. Air-handling apparatus for a surgical operating room is a device intended to produce a directed, nonturbulent flow of air that has been filtered to remove particulate matter and microorganisms to provide an area free of contaminants to reduce the possibility of infection in the patient.

Official code: I.5350. Product type: Needle-type epilator. Official classification: Class 1. A needle-type epilator is a device intended to destroy the dermal papilla of a hair by applying electric current at the tip of a fine needle that has been inserted close to the hair shaft, under the skin, and into the dermal papilla. The electric current may be high- frequency AC current, high-frequency AC combined with DC current, or DC current only.

Official code: I.5360. Product type: Tweezer-type epilator. Official classification: Class 1. The tweezer-type epilator is an electrical device intended to remove hair. The energy provided at the tip of the tweezer used to remove hair may be radio frequency, galvanic (direct current), or a combination of radio frequency and galvanic energy.

Official code: I.5400. Product type: Low level laser system. Official classification: Class 2. A Low Level Laser System is a device using low level laser energy for the disruption of adipocyte cells within the fat layer for the release of fat and lipids from these cells for noninvasive use. Classification. Class 2.

Official code: I.5650. Product type: Topical oxygen chamber for extremities. Official classification: Class 3. A topical oxygen chamber for extremities is a device intended to surround hermetically a patient's limb and apply humidified oxygen topically at a pressure slightly greater than atmospheric pressure to aid healing of chronic skin ulcers or bed sores.

Official code: I.5900. Product type: Nonpneumatic tourniquet. Official classification: Class 1. A nonpneumatic tourniquet is a device consisting of a strap or tubing intended to be wrapped around a patient's limb and tightened to reduce circulation.

Official code: I.5910. Product type: Pneumatic tourniquet. Official classification: Class 1. A pneumatic tourniquet is an air-powered device consisting of a pressure-regulating unit, connecting tubing, and an inflatable cuff. The cuff is intended to be wrapped around a patient's limb and inflated to reduce or totally occlude circulation during surgery.

Official code: I.9999. Product type: Others(General and Plastic Surgery Devices) 1,. Official classification: Class 2,3. The products excluded from the above-classification are adopted in this classification and specified by the central competent health authority.

Official code: J.0001. Product type: Saline solution for wound irrigation. Official classification: Class 2. Wound irrigation saline is a normal saline solution which uses physical means to clean the surface of a shallow skin wound.

Official code: J.0003. Product type: Medical Pressure Garment. Official classification: Class 1. Medical Pressure Garmentapply to the skin surface and insert moderate and balanced pressure to support and compress the medical equipment covered on the patient's body parts, so as to achieve the effect of pressure medical treatment.

Official code: J.0004. Product type: Ozone Disinfector. Official classification: Class 2. Disinfect medical devices by generating ozone gas or ozone water.

Official code: J.2200. Product type: Liquid crystal forehead temperature strip. Official classification: Class 1. A liquid crystal forehead temperature strip is a device applied to the forehead that is used to indicate the presence or absence of fever, or to monitor body temperature changes. The device displays the color changes of heat sensitive liquid crystals corresponding to the variation in the surface temperature of the skin. The liquid crystals, which are cholesteric esters, are sealed in plastic.

Official code: J.2420. Product type: Electronic monitor for gravity flow infusion systems. Official classification: Class 2. An electronic monitor for gravity flow infusion systems is a device used to monitor theamount of fluid being infused into a patient. The device consists of an electronic transducer and equipment for signal amplification, conditioning, and display.

Official code: J.2460. Product type: Electrically powered spinal fluid pressure monitor. Official classification: Class 2. An electrically powered spinal fluid pressure monitor is an electrically powered device used to measure spinal fluid pressure by the use of a transducer which converts spinal fluid pressure into an electrical signal. The device includes signal amplification, conditioning, and display equipment.

Official code: J.2500. Product type: Spinal fluid manometer. Official classification: Class 2. A spinal fluid manometer is a device used to measure spinal fluid pressure. The device uses a hollow needle, which is inserted into the spinal column fluid space, to connect the spinal fluid to a graduated column sothat the pressure can be measured by reading the height of the fluid.

Official code: J.2750. Product type: Image processing device for estimation of external blood loss. Official classification: Class 2. An image processing device for estimation of external blood loss is a device to be used as an aid in estimation ofpatient external blood loss. The device may include software and/or hardware that is used to process images capturing externally lost blood to estimate the hemoglobin mass and/or the blood volume present in the images.

Official code: J.2800. Product type: Sterilization process indicator. Official classification: Class 2. (a)Biological sterilization process indicator --(1)Identification: A biological sterilization process indicator is a device intended for use by a health care provider to accompany products being sterilized through a sterilization procedure and to monitor adequacy of sterilization. The device consists of a known number of microorganisms, of known resistance to the mode of sterilization, inor on a carrier and enclosed in a protective package. Subsequent growth or failure of the microorganisms to grow under suitable conditions indicates the adequacy of sterilization.(2)Classification: Class 2.(b)Physical/chemical sterilization process indicator -- (1)Identification: A physical/chemical sterilization process indicator is a device intended for use by a health care provider to accompany products being sterilized through a sterilization procedure and to monitor one or more parameters of the sterilization process. The adequacy of the sterilization conditions as measured by these parameters is indicated by a visible change in the device. (2)Classification: Class 2.

Official code: J.2900. Product type: Clinical color change thermometer. Official classification: Class 1. A clinical color change thermometer is a disposable device used to measure a patient's oral, rectal, or axillary (armpit) body temperature. The device records body temperature by use of heat sensitive chemicals which are sealed at the end of a plastic or metal strip. Body heat causes a stable color change in the heat sensitive chemicals.

Official code: J.2910. Product type: Clinical electronic thermometer. Official classification: Class 2. A clinical electronic thermometer is a device used to measure the body temperature of a patient by means of a transducer coupled with an electronic signal amplification, conditioning, and display unit. The transducer may be in a detachable probe with orwithout a disposable cover.

Official code: J.2920. Product type: Clinical mercury thermometer. Official classification: Class 1. A clinical mercury thermometer is a device used to measure oral, rectal, or axillary (armpit) body temperature using the thermal expansion of mercury.

Official code: J.5025. Product type: I.V. container. Official classification: Class 2. An I.V. container is a container made of plastic or glass used to hold a fluid mixture to be administered to a patient through an intravascular administration set.

Official code: J.5045. Product type: Medical recirculating air cleaner. Official classification: Class 2. A medical recirculating air cleaner is a device used to remove particles from the air for medical purposes. The device may function by electrostatic precipitation or filtration.

Official code: J.5075. Product type: Elastic bandage. Official classification: Class 1,2. An elastic bandage is a device consisting of either a long flat strip or a tube of elasticized material that is used to support and compress a part of a patient's body. Classification: (1) Class 2: devices that are intended for third degree burns, stitch-free (replacing surgical suture), drugs or biological reagents (e.g., growth hormone), containing antibacterial ingredients, etc.;(2) Class 1: other devices.

Official code: J.5090. Product type: Liquid bandage. Official classification: Class 1,2. A liquid bandage is a liquid, semiliquid, or powder and liquid combination used to cover an opening in the skin or as a dressing for burns. The device is also used as a topical skin protectant.Classification: (1)Class 2 devices that are intended for patients with class 3 burning wound, free sewing(replacing surgical suture), contain added drugs such as antimicrobial agents, added biologics such as growth factors, or is composed of materials derived from animal sources.;(2)Class 1 other devices.

Official code: J.5100. Product type: AC-powered adjustable hospital bed. Official classification: Class 1. An AC-powered adjustable hospital bed is a device intended for medical purposes that consists of a bed with a built-in electric motor and remote controls that can be operated by thepatient to adjust the height and surface contour of the bed. The device includes movable and latchable side rails.

Official code: J.5110. Product type: Hydraulic adjustable hospital bed. Official classification: Class 1. A hydraulic adjustable hospital bed is a device intended for medical purposes that consists of abed with a hydraulic mechanism operated by an attendant to adjust the height and surface contour of the bed. The device includes movable and latchable side rails.

Official code: J.5120. Product type: Manual adjustable hospital bed. Official classification: Class 1. A manual adjustable hospital bed is a device intended for medical purposes that consists of a bed with a manual mechanism operated by an attendant to adjust the height and surface contour of the bed. The device includes movable and latchable side rails.

Official code: J.5130. Product type: Infant radiant warmer. Official classification: Class 2. The infant radiant warmer is a device consisting of an infrared heating element intended to be placed over an infant to maintain the infant's body temperature by means of radiant heat. The device may also contain a temperature monitoring sensor, a heat output control mechanism, and an alarm system (infant temperature, manual mode if present, and failure alarms) to alert operators of a temperature condition over or under the set temperature, manual mode time limits, and device component failure, respectively. The device may be placed over a pediatric hospital bed or it may be built into the bed as a complete unit.

Official code: J.5140. Product type: Pediatric medical bed. Official classification: Class 1. A pediatric medical bed is intended for medical purposes for use with a pediatric patient that consists of an open crib, fixed end rails, movable and latchable side rail components, and possibly an accompanying mattress. The contour of the crib surface may be adjustable.

Official code: J.5150. Product type: Nonpowered flotation therapy mattress. Official classification: Class 1. A nonpowered flotation therapy mattress is a mattress intended for medical purposes which contains air, fluid, or similar materials that have the functionally equivalent effect of supporting a patient and avoiding excess pressure on local body areas. The device is intended to treat or prevent decubitus ulcers (bed sores).

Official code: J.5160. Product type: Therapeutic medical binder. Official classification: Class 1. A therapeutic medical binder is a device, usually made of cloth, that is intended for medical purposes and that can be secured by ties so that it supports the underlying part of the body or holds a dressing in place. This generic type of device includes the abdominal binder, breast binder, and perineal binder.

Official code: J.5180. Product type: Burn sheet. Official classification: Class 1,2. A burn sheet is a device made of a porous material that is wrapped aroung a burn victim to retain body heat, to absorb wound exudate, and to serve as a barrier against contaminants. Classification: (1) Class 2 devices that are intended for third degree burns, stitch-free (replacing surgical suture), drugs or biological reagents (e.g.,growth hormone), containing antibacterial ingredients, etc.;(2) Class 1 other devices.

Official code: J.5200. Product type: Intravascular catheter. Official classification: Class 2. An intravascular catheter is a device that consists of a slender tube and any necessary connecting fittings and that is inserted into the patient's vascular system for short term use (less than 30 days) to sample blood, monitor blood pressure, or administer fluids intravenously. The device may be constructed of metal, rubber, plastic, or a combination of these materials.

Official code: J.5210. Product type: Intravascular catheter securement device. Official classification: Class 1. An intravascular catheter securement device is a device with an adhesive backing that is placed over a needle or catheter and is used to keep the hub of the needle or the catheter flat and securely anchored to the skin.

Official code: J.5240. Product type: Medical adhesive tape and adhesive bandage. Official classification: Class 1,2. A medicaladhesive tape or adhesive bandage is a device intended for medical purposes that consists of a strip of fabric material or plastic, coated on one side with an adhesive, and may include a pad of surgical dressing without a disinfectant. The device is used to cover and protect wounds, to hold together the skin edges of a wound, to support an injured part of the body, or to secure objects to the skin. Classification: (1)Class 2 devices that are intended for patients with class 3 burning wound, free sewing(replacing surgical suture), contain added drugs such as antimicrobial agents, added biologics such as growth factors, or is composed of materials derived from animal sources.;(2)Class 1 other devices.

Official code: J.5270. Product type: Neonatal eye pad. Official classification: Class 1. A neonatal eye pad is an opaquedevice used to cover and protect the eye of an infant during therapeutic procedures, such as phototherapy.

Official code: J.5300. Product type: Medical absorbent fiber. Official classification: Class 1. A medical absorbent fiber is a device intended for medical purposes that is made from cotton or synthetic fiber inthe shape of a ball or a pad and that is used for applying medication to, or absorbing small amounts of body fluids from, a patient's body surface. Absorbent fibers intended solely for cosmetic purposes are not included in this generic device category.

Official code: J.5400. Product type: Neonatal incubator. Official classification: Class 2. A neonatal incubator is a device consisting of a rigid boxlike enclosure in which an infant may be kept in a controlled environment for medical care. The device may include an AC-powered heater, a fan to circulate the warmed air,a container for water to add humidity, a control valve through which oxygen may be added, and access ports for nursing care.

Official code: J.5410. Product type: Neonatal transport incubator. Official classification: Class 2. A neonatal transport incubator is a device consisting of a portable rigid boxlike enclosurewith insulated walls in which an infant may be kept in a controlled environment while being transported for medical care. The device may include straps to secure the infant, a battery-operated heater, an AC-powered battery charger, a fan to circulate thewarmed air, a container for water to add humidity, and provision for a portable oxygen bottle.

Official code: J.5420. Product type: Pressure infusor for an I.V. bag. Official classification: Class 1. A pressure infusor for an I.V. bag is a device consisting of an inflatable cuff which is placed around an I.V. bag. When the device is inflated, it increases the pressure on the I.V. bag to assist the infusion of the fluid.

Official code: J.5430. Product type: Nonelectrically powered fluid injector. Official classification: Class 2. A nonelectrically powered fluid injector is a nonelectrically powered device used by a health care provider to give a hypodermic injection by means of a narrow, high velocity jet of fluid which can penetrate the surface of the skin and deliver the fluidto the body. It may be used for mass inoculations.

Official code: J.5440. Product type: Intravascular administration set. Official classification: Class 2. An intravascular administration set is a device used to administer fluids from a container to a patient's vascular system through a needle or catheter inserted into a vein. The device may include the needle or catheter, tubing, a flow regulator, a drip chamber, an infusion line filter, an I.V. set stopcock, fluid delivery tubing, connectors between parts of the set, a side tube with a cap to serve as an injection site, and a hollow spike to penetrate and connect the tubing to an I.V. bag or other infusion fluid container.

Official code: J.5450. Product type: Patient care reverse isolation chamber. Official classification: Class 2. A patient care reverse isolation chamber is a device consisting of a roomlike enclosure designed to prevent the entry of harmful airborne material. This device protects a patient who is undergoing treatment for burns or is lacking a normal immunosuppressive defense due to therapy or congenital abnormality. The device includes fans and air filters which maintain an atmosphere of clean air at a pressure greater than the air pressure outside the enclosure.

Official code: J.5475. Product type: Jet lavage. Official classification: Class 1. A jet lavage is a device used to clean a wound by a pulsatile jet of sterile fluid. The device consists of the pulsing head,tubing to connect to a container of sterile fluid, and a means of propelling the fluid through the tubing, such as an electric roller pump.

Official code: J.5500. Product type: AC-powered patient lift. Official classification: Class 1. An AC-powered lift is an electrically powered device either fixed or mobile, used to lift and transport patients in the horizontalor other required position from one place to another, as from a bed to a bath. The device includes straps and slings to support the patient.

Official code: J.5510. Product type: Non-AC-powered patient lift. Official classification: Class 1. A non-AC-powered patient lift is a hydraulic, battery, or mechanically powered device, either fixed or mobile, used to lift and transport a patient in the horizontal or other required position from one place to another, as from a bed to a bath. The device includes straps and a sling to support the patient.

Official code: J.5550. Product type: Alternating pressure air flotation mattress. Official classification: Class 1. An alternating pressure air flotation mattress is a device intended for medical purposes that consists of a mattress with multiple air cells that can be filled and emptied in an alternating pattern by an associated control unit to provide regular, frequent, and automatic changes in the distribution of body pressure. The device is used to prevent and treat decubitus ulcers (bed sores).

Official code: J.5560. Product type: Temperature regulated water mattress. Official classification: Class 1. A temperature regulated water mattress is a device intended for medical purposes that consists of a mattress of suitable size, filled with water which can be heated or in some cases cooled. The device includes electrical heating and water circulating components, and an optional cooling component. The temperature control may be manual or automatic.

Official code: J.5570. Product type: Hypodermic single lumen needle. Official classification: Class 2. A hypodermic single lumen needle is a device intended to inject fluids into, or withdraw fluids from, parts of the body belowthe surface of the skin. The device consists of a metal tube that is sharpened at one end and at the other end joined to a female connector (hub) designed to mate with a male connector (nozzle) of a piston syringe or an intravascular administration set.

Official code: J.5580. Product type: Acupuncture needle. Official classification: Class 2. An acupuncture needle is a device intended to pierce the skin in the practice of acupuncture. The device consists of a solid, stainless steel needle. The device may have a handle attached to the needle to facilitate the delivery of acupuncture treatment.

Official code: J.5680. Product type: Pediatric position holder. Official classification: Class 1. A pediatric position holder is a deviceused to hold an infant or a child in a desired position for therapeutic or diagnostic purposes, e.g., in a crib under a radiant warmer, or to restrain a child while an intravascular injection is administered.

Official code: J.5700. Product type: Neonatal phototherapy unit. Official classification: Class 2. A neonatalphototherapy unit is a device used to treat or prevent hyperbilirubinemia (elevated serum bilirubin level). The device consists of one or more lamps that emit a specific spectral band of light, under which an infant is placed for therapy. Thisgeneric type of device may include supports for the patient and equipment and component parts.

Official code: J.5725. Product type: Infusion pump. Official classification: Class 2. An infusion pump is a device used in a health care facility to pump fluids into a patient in a controlled manner. The devicemay use a piston pump,a roller pump, or a peristaltic pump and may be powered electrically or mechanically. The device may also operate using a constant force to propel the fluid through a narrow tube which determines the flow rate. The device may include means to detect a fault condition, such as air in, or blockage of, the infusion line and to activate an alarm.

Official code: J.5740. Product type: Suction snakebite kit. Official classification: Class 1. A suction snakebite kit is a device consisting of a knife, suction device, and tourniquet used for first-aid treatment of snakebites by removing venom from the wound.

Official code: J.5760. Product type: Chemical cold pack snakebite kit. Official classification: Class 3. A chemical cold pack snakebit kit is a device consisting of a chemical cold pack and tourniquet used for first-aid treatment of snakebites.

Official code: J.5780. Product type: Medical support stocking. Official classification: Class 2. A medical support stocking is a device that is constructed of elastic material and designed to apply controlled pressure to the leg, providing pressure that gradually decreases from the ankle upwardsto prevent the pooling of blood orinterstitial fluidin the legs for medical purposes.

Official code: J.5820. Product type: Therapeutic scrotal support. Official classification: Class 1. A therapeutic scrotal support is a device intended for medical purposes that consist of a pouch attached to an elastic waistband and that is used to support the scrotum (the sac that contains the testicles).

Official code: J.5860. Product type: Piston syringe. Official classification: Class 2. A piston syringe is a device intended for medical purposes that consists of a calibrated hollow barrel and a movable plunger.At one end of the barrel there is a male connector (nozzle) for fitting the female connector (hub) of a hypodermic single lumen needle. The device is used to inject fluids into, or withdraw fluids from the body.

Official code: J.5950. Product type: Umbilical occlusion device. Official classification: Class 1. An umbilical occlusion device is a clip, tie, tape, or other article used to close the blood vessels in the umbilical cord of a newborn infant.

Official code: J.5965. Product type: Subcutaneous, implanted, intravascular infusion port and catheter. Official classification: Class 2. A subcutaneous, implanted, intravascular infusion port and catheter is a device that consists of a subcutaneous, implanted reservoir that connects to a long-term intravascular catheter. The device allows for repeated access to the vascular system for the infusion of fluids and medications and the sampling of blood. The device consists of a portal body with a resealable septum and outlet made of metal, plastic, or combination of these materials and a long-term intravascular catheter is either preattached to the port or attached to the port at the time of device placement. The device is available in various profiles and sizes and can beof a single or multiple lumen design.

Official code: J.5970. Product type: Percutaneous, implanted, long-term intravascular catheter. Official classification: Class 2. A percutaneous, implanted, long-term intravascular catheter is a device that consists of a slender tube and any necessary connecting fittings, such asluer hubs, and accessories that facilitate the placement of the device. The device allows for repeated access to the vascular system for long-term use of 30 days or more, and it is intended for administration of fluids, medications, and nutrients; the sampling of blood; and monitoring blood pressure and temperature. The device may be constructed of metal, rubber, plastic, composite materials, or any combination of these materials and may be of single or multiple lumen design.

Official code: J.6025. Product type: Absorbent tipped applicator. Official classification: Class 1. An absorbent tipped applicator is a device intended for medical purposes that consists of an absorbent swab on a wooden, paper, or plastic stick. The device is used to apply medications to, or to take specimens from a patient.

Official code: J.6100. Product type: Ethylene oxide gas aerator cabinet. Official classification: Class 2. An ethyene oxide gas aerator cabinet is a device that is intended for use by a health care provider and consists of a cabinetwith a ventilation system designed to circulate and exchange the air in the cabinet to shorten the time required to remove residual ethylene oxide (ETO) from wrapped medical devices that have undergone ETO sterilization. The device may include a heater to warm the circulating air.

Official code: J.6150. Product type: Ultrasonic cleaner for medical instruments. Official classification: Class 1. An ultrasonic cleaner for medical instruments is a device intended for cleaning medical instruments by the emission of high frequency soundwaves.

Official code: J.6230. Product type: Tongue depressor. Official classification: Class 1. A tongue depressor is a device intended to displace the tongue to facilitate examination of the surrounding organs and tissues.

Official code: J.6250. Product type: Patient examination glove. Official classification: Class 1. A patient examination glove is a disposable device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner. Materials of patientexamination gloves should comply with the barrier property (water leak) and tensile strength requirements of ISO 11193-1, ASTM D 3578, ASTM D 5250, ASTM D 6319, EN 455 or equivalent standards. A non-powdered (powder free) patient examination glove shouldcomply with residual powders requirements of EN ISO 21171, ASTM D 6124 or equivalent standards. The averageamount of residual powders on a glove should not exceed 2.0 mg.

Official code: J.6300. Product type: Implantable radiofrequency transponder system for patient identification and health information. Official classification: Class 2. An implantable radiofrequency transponder system for patient identification and health information is a device intended to enable access to secure patient identification and corresponding health information. This system may include apassive implanted transponder, inserter, and scanner. The implanted transponder is used only to store a unique electronic identification code that is read by the scanner. The identification code is used to access patient identity and corresponding health information stored in a database.

Official code: J.6375. Product type: Patient lubricant. Official classification: Class 1. A patient lubricant is a device intended for medical purposes that is used to lubricate a body orifice to facilitate entry ofa diagnostic or therapeutic device.

Official code: J.6430. Product type: Liquid medication dispenser. Official classification: Class 1. A Liquid medication dispenser is a device intended for medical purposes that is used to issue a measured amount of liquid medication.

Official code: J.6450. Product type: Skin pressure protectors. Official classification: Class 1. A skin pressure protector is a device intended for medical purposes that is used to reduce pressure on the skin over a bony prominence to reduce the likelihood of the patient's developing decubitus ulcers (bedsores).

Official code: J.6600. Product type: Ultraviolet (UV) radiation chamber disinfection device. Official classification: Class 2. An ultraviolet (UV) radiation chamber disinfection device is intended for the low-level surface disinfection of non-porous equipment surfaces by dose-controlled UV irradiation. This classification does not include self-contained open chamber UV radiation disinfection devices intended for whole room disinfection in a health care environment.

Official code: J.6740. Product type: Vacuum-powered body fluid suction apparatus. Official classification: Class 1. A vacuum-powered body fluid suction apparatus is a device used to aspirate, remove, or sample body fluids. The device is powered by an external source of vacuum. This generic type of device includes vacuum regulators, vacuum collection bottles, suction catheters and tips, connecting flexible aspirating tubes, rigid suction tips, specimen traps, noninvasive tubing, and suction regulators (with gauge).

Official code: J.6775. Product type: Powered patient transfer device. Official classification: Class 1. A powered patient transfer device is a device consisting of a wheeled stretcher and a powered mechanism that has a broad, flexible band stretched over long rollers that can advance itself under a patient and transfer the patient with minimal disturbance in a horizontal position to the stretcher.

Official code: J.6785. Product type: Manual patient transfer device. Official classification: Class 1. A manual patient transfer device is a device consisting of a wheeled stretcher and a mechanism on which a patient can be placed so that the patient can be transferred with minimal disturbance in a horizontal position to the stretcher.

Official code: J.6820. Product type: Medical disposable scissors. Official classification: Class 1. Medical disposable scissors are disposable type general cutting devices intended for medical purposes. This generic type of device does not include surgical scissors.

Official code: J.6850. Product type: Sterilization wrap. Official classification: Class 2. A sterilization wrap (pack, sterilization wrapper, bag, or accessories, is a device intended to be used to enclose another medical device that is to be sterilized by a health care provider. It is intended to allow sterilization of the enclosed medical device and also to maintain sterility of the enclosed device until used.

Official code: J.6860. Product type: Ethylene oxide gas sterilizer. Official classification: Class 2. An ethylene gas sterilizer is a nonportable device intended for use by a health care provider that uses ethylene oxide (ETO) to sterilize medical products.

Official code: J.6870. Product type: Dry-heat sterilizer. Official classification: Class 2. A dry-heat sterilizer is a device that is intended for use by a health care provider to sterilize medical products by means of dry heat.

Official code: J.6880. Product type: Steam sterilizer. Official classification: Class 2. A steam sterilizer (autoclave) is a device that is intended for use by a health care provider to sterilize medical products by means of pressurized steam.

Official code: J.6885. Product type: Liquid chemical sterilants/high level disinfectants. Official classification: Class 2. A liquid chemical sterilant/high level disinfectant is a germicide that is intended for use as the terminal step in processing critical and semicritical medical devices prior to patient use. Critical devices make contact with normally sterile tissue or body spaces during use. Semicritical devices make contact during use with mucous membranes or nonintact skin.

Official code: J.6890. Product type: General purpose disinfectants. Official classification: Class 1. A general purpose disinfectant is a germicide used on the surfaces ofnoncritical medical devices. A general purpose disinfectant can be used to preclean or decontaminate critical or semicritical medical devices prior to terminal sterilization or high level disinfection. Noncritical medical devices make only topical contact with intact skin surfaces.

Official code: J.6900. Product type: Hand-carried stretcher. Official classification: Class 1. A hand-carried stretcher is a device consisting of a lightweight frame, or of two poles with a cloth or metal platform, on which a patient can be carried.

Official code: J.6910. Product type: Wheeled stretcher. Official classification: Class 1. A wheeled stretcher is a device consisting of a platform mounted on a wheeled frame that is designed to transport patients in a horizontal position. The device may have side rails, supports for fluid infusion equipment, and patient securement straps. The frame may be fixed or collapsible for use in an ambulance.

Official code: J.6920. Product type: Syringe needle introducer. Official classification: Class 2. A syringe needle introducer is a device that uses a spring-loaded mechanism to drive a hypodermic needle into a patient to a predetermined depth below the skin surface.

Official code: J.6960. Product type: Irrigating syringe. Official classification: Class 1. An irrigating syringe is a device intended for medical purposes that consists of a bulb or a piston syringe with an integral or a detachable tube. The device is used to irrigate, withdraw fluid from, or instill fluid into, a body cavity or wound.

Official code: J.6970. Product type: Liquid crystal vein locator. Official classification: Class 1. A liquid crystal veinlocator is a device used to indicate the location of a vein by revealing variations in the surface temperature of the skin by displaying the color changes of heat sensitive liquid crystals (cholesteric esters).

Official code: J.6980. Product type: Vein stabilizer. Official classification: Class 1. A vein stabilizeris a device consisting of a flat piece of plastic with two noninvasive prongs. The device is placed on the skin so that the prongs are on either side of a vein and hold it stable while a hypodermic needle is inserted into the vein.

Official code: J.6991. Product type: Medical washer. Official classification: Class 2. A medical washer is a device that is intended for general medical purposes to clean surgical instruments, anesthesia equipment, hollowware, and other medical devices.

Official code: J.6992. Product type: Medical washer-disinfector. Official classification: Class 2. A medical washer-disinfector is a device that is intended for general medical purposes to clean, decontaminate, disinfect, and dry surgical instruments, anesthesia equipment, hollowware, and other medical devices.

Official code: J.9999. Product type: Others(General Hospital and Personal Use Devices) 1,. Official classification: Class 2,3. The products excluded from the above-classification are adopted in this classification and specified by the central competent health authority.

Official code: K.1020. Product type: Rigidity analyzer. Official classification: Class 2. A rigidity analyzer is a device for quantifying the extent of the rigidity of a patient's limb to determine the effectiveness of drugs or other treatments.

Official code: K.1030. Product type: Ataxiagraph. Official classification: Class 1. An ataxiagraph is a device used to determine the extent of ataxia (failure of muscular coordination) by measuring the amountof swaying of the body when the patient is standing erect and with eyes closed.

Official code: K.1200. Product type: Two-point discriminator. Official classification: Class 1. A two-point discriminator is a device with points used for testing a patient's touch discrimination.

Official code: K.1240. Product type: Echoencephalograph. Official classification: Class 2. An echoencephalograph is an ultrasonic scanning device (including A-scan, B-scan, and doppler systems) that uses noninvasive transducers for measuring intracranial interfaces and blood flow velocity to and in the head.

Official code: K.1275. Product type: Electroconductive media. Official classification: Class 2. Electroconductive media are the conductive creams or gels used with external electrodes to reduce the impedance (resistance to alternating current) of the contact between the electrode surface and the skin.

Official code: K.1310. Product type: Cortical electrode. Official classification: Class 2. A cortical electrode is an electrode which is temporarily placed on the surface of the brain for stimulating the brain or recording the brain's electrical activity.

Official code: K.1320. Product type: Cutaneous electrode. Official classification: Class 2. A cutaneous electrode is an electrode that is applied directly to a patient's skin either to record physiological signals (e.g.,the electroencephalogram) or to apply electrical stimulation.

Official code: K.1330. Product type: Depth electrode. Official classification: Class 2. A depth electrode is an electrode used for temporary stimulation of, or recording electrical signals at, subsurface levels of the brain.

Official code: K.1340. Product type: Nasopharyngeal electrode. Official classification: Class 2. A nasopharyngeal electrode isan electrode which is temporarily placed in the nasopharyngeal region for the purpose of recording electrical activity.

Official code: K.1350. Product type: Needle electrode. Official classification: Class 2. A needle electrode is a device which is placed subcutaneously to stimulate or to record electrical signals.

Official code: K.1400. Product type: Electroencephalograph. Official classification: Class 2. An electroencephalograph is a device used to measure and record the electrical activity of the patient's brain obtained by placing two or more electrodes on the head.

Official code: K.1420. Product type: Electroencephalogram EEG signal spectrum analyzer. Official classification: Class 1. An electroencephalogram (EEG) signal spectrum analyzer is a device used to display the frequency content or power spectral density of the electroencephalogram (EEG) signal.

Official code: K.1460. Product type: Nystagmograph. Official classification: Class 2. A nystagmograph is a device used to measure, record, or visually display the involuntary movements (nystagmus) of the eyeball.

Official code: K.1480. Product type: Neurological endoscope. Official classification: Class 2. A neurological endoscope is an instrument with a light source used to view the inside of the ventricles of the brain.

Official code: K.1500. Product type: Esthesiometer. Official classification: Class 1. An esthesiometer is a mechanical device which usually consists of a single rod or fiber which is held in the fingers of the physician or other examiner and which is used to determine whether a patient has tactile sensitivity.

Official code: K.1525. Product type: Tuning fork. Official classification: Class 1. A tuning fork is amechanical device which resonates at a given frequency and is used to diagnose hearing disorders and to test for vibratory sense.

Official code: K.1540. Product type: Galvanic skin response measurement device. Official classification: Class 2. A galvanic skin response measurement device is a device used to determineautonomic responses as psychological indicators by measuring the electrical resistance of the skin and the tissue path between two electrodes applied to the skin.

Official code: K.1550. Product type: Nerve conduction velocity measurement device. Official classification: Class 2. A nerve conduction velocity measurement device is a device which measures nerve conduction time by applying a stimulus, usually to a patient's peripheral nerve. This device includes the stimulator and the electronic processing equipment for measuring and displaying the nerve conduction time.

Official code: K.1560. Product type: Skin potential measurement device. Official classification: Class 2. A skin potential measurement device is a general diagnostic device used to measure skin voltage by means of surface skin electrodes.

Official code: K.1570. Product type: Powered direct-contact temperature measurement device. Official classification: Class 2. A powered direct-contact temperature measurement device is a device which contains a power source and is used to measure differences in temperature between two points on the body.

Official code: K.1580. Product type: Non-electroencephalogram (non-EEG) physiological signal based seizure monitoring system. Official classification: Class 2. A non-electroencephalogram (non-EEG) physiological signal based seizure monitoring system is a noninvasive device that collects physiological signals other than EEG to identify physiological signals that may be associated with a seizure.

Official code: K.1610. Product type: Alpha monitor. Official classification: Class 2. An alpha monitor is a device with electrodes that are placed on a patient's scalp to monitor that portion of the electroencephalogram which is referred to as the alpha wave.

Official code: K.1620. Product type: Intracranial pressure monitoring device. Official classification: Class 2. An intracranial pressure monitoring device is a device used for short-term monitoring and recording of intracranial pressures and pressure trends. The device includes the transducer, monitor, and interconnecting hardware.

Official code: K.1630. Product type: Cranial motion measurement device. Official classification: Class 2. A cranialmotion measurement device is a device that utilizes accelerometers to measure the motion or acceleration of the skull. These measurements are not to be used independently for diagnostic purposes.

Official code: K.1750. Product type: Pinwheel. Official classification: Class 1. A pinwheel is a device with sharp points on a rotating wheel used for testing pain sensation.

Official code: K.1790. Product type: Ocular plethysmograph. Official classification: Class 3. An ocular plethysmograph is a device used to measure or detect volume changes in the eye produced by pulsations of the artery, to diagnose carotid artery occlusive disease (restrictions on blood flow in the carotid artery).

Official code: K.1825. Product type: Rheoencephalograph. Official classification: Class 3. A rheoencephalograph is a device used to estimate a patient's cerebral circulation (blood flow in the brain) by electrical impedance methods with direct electrical connections to the scalp or neck area.

Official code: K.1835. Product type: Physiological signal amplifier. Official classification: Class 2. A physiological signal amplifier is a general purpose device used to electrically amplify signals derived from various physiological sources (e.g., the electroencephalogram).

Official code: K.1845. Product type: Physiological signal conditioner. Official classification: Class 2. A physiological signal conditioner is a device such as an integrator or differentiator used to modify physiological signals for recording and processing.

Official code: K.1855. Product type: Electroencephalogram (EEG)telemetry system. Official classification: Class 2. An electroencephalogram (EEG) telemetry system consists of transmitters, receivers, and other components used for remotely monitoring or measuring EEG signals by means of radio or telephone transmission systems.

Official code: K.1870. Product type: Evoked response electrical stimulator. Official classification: Class 2. An evoked response electrical stimulator is a device used to apply an electrical stimulus to a patient by means of skin electrodes for the purpose of measuring the evoked response.

Official code: K.1880. Product type: Evoked response mechanical stimulator. Official classification: Class 2. An evoked response mechanical stimulator is a device used to produce a mechanical stimulus or a series of mechanical stimuli for the purpose of measuring a patient's evoked response.

Official code: K.1890. Product type: Evoked response photic stimulator. Official classification: Class 2. An evoked response photic stimulator is a device used to generate and display a shifting pattern or to apply a brief light stimulus to a patient's eye for use in evoked response measurements or for electroencephalogram (EEG) activation.

Official code: K.1900. Product type: Evoked response auditory stimulator. Official classification: Class 2. An evoked response auditory stimulator is a device that produces a sound stimulus for use in evoked response measurements or electroencephalogram activation.

Official code: K.1935. Product type: Near infared (NIR) brain hematoma detector. Official classification: Class 2. A Near Infrared (NIR) Brain Hematoma Detector is a noninvasive device that employs near-infrared spectroscopy that is intended to be used to evaluate suspected brain hematomas. Classification. Class 2.

Official code: K.1950. Product type: Tremor transducer. Official classification: Class 2. A tremor transducer is a device used to measure the degree of tremor caused by certain diseases.

Official code: K.4030. Product type: Skull plate anvil. Official classification: Class 1. A skull plate anvil is a device used to form alterable skull plates in the proper shape to fit the curvature of a patient's skull.

Official code: K.4060. Product type: Ventricular cannula. Official classification: Class 1. A ventricular cannula is a device used to puncture the ventricles of the brain for aspiration or for injection. This device is frequently referred to as a ventricular needle.

Official code: K.4100. Product type: Ventricular catheter. Official classification: Class 2. A ventricular catheter is a device used to gain access to the cavities of the brain for injection of material into, or removalof material from, the brain.

Official code: K.4125. Product type: Neurosurgical chair. Official classification: Class 1. A neurosurgical chair is an operating room chair used to position and support a patient during neurosurgery.

Official code: K.4150. Product type: Scalp clip. Official classification: Class 2. A scalp clip is a plastic or metal clip used to stop bleeding during surgery on the scalp.

Official code: K.4175. Product type: Aneurysm clip applier. Official classification: Class 2. An aneurysm clip applier is a device used by the surgeon for holding and applying intracranial aneurysm clips.

Official code: K.4190. Product type: Clip forming/cutting instrument. Official classification: Class 1. A clip forming/cutting instrument is a device used by the physician to make tissue clips from wire stock.

Official code: K.4200. Product type: Clip removal instrument. Official classification: Class 1. A clip removal instrument is a device used to remove surgical clips from the patient.

Official code: K.4250. Product type: Cryogenic surgical device. Official classification: Class 2. A cryogenic surgical device is a device used to destroy nervous tissue or produce lesions in nervous tissue by the application of extreme cold to the selected site.

Official code: K.4275. Product type: Dowel cutting instrument. Official classification: Class 2. A dowel cutting instrument is a device used to cut dowels of bone for bone grafting.

Official code: K.4300. Product type: Manual cranial drills, burrs, trephines, and their accessories. Official classification: Class 2. Manual cranial drills, burrs, trephines, and their accessories are bone cutting and drilling instruments that are used without a power source on a patient's skull.

Official code: K.4305. Product type: Powered compound cranial drills, burrs, trephines, and their accessories. Official classification: Class 2. Powered compound cranial drills, burrs, trephines, and their accessories are bone cutting and drilling instruments used on apatient's skull. The instruments employ a clutch mechanism to disengage the tipof the instrument after penetrating the skull to prevent plunging of the tip into the brain.

Official code: K.4310. Product type: Powered simple cranial drills, burrs, trephines, and their accessories. Official classification: Class 2. Powered simple cranial drills, burrs, trephines, and their accessories are bone cutting and drilling instruments used on a patient's skull. The instruments are used with a power source but do not have a clutch mechanism to disengage the tip after penetratingthe skull.

Official code: K.4325. Product type: Cranial drill handpiece (brace ). Official classification: Class 1. A cranial drill handpiece (brace) is a hand holder, which is used without a power source, for drills, burrs, trephines, or other cutting tools that are used on a patient's skull.

Official code: K.4360. Product type: Electric cranial drill motor. Official classification: Class 2. An electric cranial drill motor is an electrically operated power source used with removable rotating surgical cutting tools or drill bits on a patient's skull.

Official code: K.4370. Product type: Pneumatic cranial drill motor. Official classification: Class 2. A pneumatic cranial drill motor is a pneumatically operated power source used with removable rotating surgical cutting tools or drill bits on a patient's skull.

Official code: K.4400. Product type: Radiofrequency lesion generator. Official classification: Class 2. A radiofrequency lesion generator is a device used to produce lesions in the nervous system or other tissue by the direct application of radiofrequency currents to selected sites.

Official code: K.4460. Product type: Neurosurgical head holder (skull clamp). Official classification: Class 2. A neurosurgical head holder (skull clamp) is a device used to clamp the patient's skull to hold head and neck in a particularposition during surgical procedures.

Official code: K.4500. Product type: Cranioplasty material forming instrument. Official classification: Class 1. A cranioplasty material forming instrument is a roller used in the preparation and forming of cranioplasty (skull repair) materials.

Official code: K.4525. Product type: Microsurgical instrument. Official classification: Class 1. A microsurgical instrument is a nonpowered surgical instrument used in neurological microsurgery procedures.

Official code: K.4535. Product type: Nonpowered neurosurgical instrument. Official classification: Class 1. A nonpowered neurosurgical instrument is a hand instrument or an accessory to a hand instrument used during neurosurgical procedures to cut, hold, or manipulate tissue. Itincludes specialized chisels, osteotomes, curettes, dissectors, elevators, forceps, gouges, hooks, surgical knives, rasps, scissors, separators, spatulas, spoons, blades, blade holders, blade breakers, probes, etc.

Official code: K.4545. Product type: Shunt system implantation instrument. Official classification: Class 1. A shunt system implantation instrument is an instrument used in the implantation of cerebrospinal fluid shunts, and includes tunneling instruments for passing shunt components under the skin.

Official code: K.4560. Product type: Stereotaxic instrument. Official classification: Class 2. A stereotaxic instrumentis a device consisting of a rigid frame with a calibrated guide mechanism for precisely positioning probes or other devices within a patient's brain, spinal cord, or other part of the nervous system.

Official code: K.4600. Product type: Leukotome. Official classification: Class 1. A leukotome is a device used to cut sections out of the brain.

Official code: K.4650. Product type: Neurosurgical suture needle. Official classification: Class 1. A neurosurgical suture needle is a needle used in suturing during neurosurgical procedures or in the repair of nervous tissue.

Official code: K.4700. Product type: Cottonoid paddie. Official classification: Class 2. A neurosurgical paddie is a pad used during surgery to protect nervous tissue, absorb fluids, or stop bleeding.

Official code: K.4725. Product type: Radiofrequency lesion probe. Official classification: Class 2. A radiofrequency lesion probe is a device connected to a radiofrequency (RF) lesion generator to deliver the RF energy to thesite within the nervous system where a lesion is desired.

Official code: K.4750. Product type: Skull punch. Official classification: Class 1. A skull punch is a device used to punch holes through a patient's skull to allow fixation of cranioplasty plates or bone flaps by wire or other means.

Official code: K.4800. Product type: Self-retaining retractor for neurosurgery. Official classification: Class 2. A self-retaining retractor for neurosurgery is a self-locking device used to hold the edges of a wound open during neurosurgery.

Official code: K.4840. Product type: Manual rongeur. Official classification: Class 2. A manual rongeur is a manually operated instrument used for cutting or biting bone during surgery involving the skull or spinal column.

Official code: K.4845. Product type: Powered rongeur. Official classification: Class 2. A powered rongeur is a powered instrument used for cutting or biting bone during surgery involving the skull or spinal column.

Official code: K.4900. Product type: Skullplate screwdriver. Official classification: Class 1. A skullplate screwdriver is a tool used by the surgeon to fasten cranioplasty plates or skullplates to a patient's skull by screws.

Official code: K.5030. Product type: Methyl methacrylate for aneurysmorrhaphy. Official classification: Class 2. Methyl methacrylate for aneurysmorrhaphy (repair of aneurysms, which are balloonlike sacs formed on blood vessels) is a self- curing acrylic used to encase and reinforce intracranial aneurysms that are not amenable to conservative management, removal,or obliteration by aneurysm clip.

Official code: K.5050. Product type: Biofeedback device. Official classification: Class 2. A biofeedback device is an instrument that provides a visual or auditory signal corresponding to the status of one or more of a patient's physiological parameters (e.g., brain alpha wave activity, muscle activity, skin temperature, etc.) so that the patient can control voluntarily these physiological parameters.

Official code: K.5070. Product type: Bite block. Official classification: Class 2. A bite block is a device inserted into a patient's mouth to protect the tongue and teeth while the patient is having convulsions.

Official code: K.5150. Product type: Intravascular occluding catheter. Official classification: Class 3. An intravascular occluding catheter is a catheter with an inflatable or detachable balloon tip that is used to block a blood vessel to treat malformations, e.g., aneurysms (balloonlike sacs formed on blood vessels) of intracranial blood vessels.

Official code: K.5175. Product type: Cartoid artery clamp. Official classification: Class 2. A carotid artery clampis a device that is surgically placed around a patient's carotid artery (the principal artery in the neck that supplies blood to the brain) and has a removable adjusting mechanism that protrudes through the skin of the patient's neck. The clamp is used toocclude the patient's carotid artery to treat intracranial aneurysms (balloonlike sacs formed on blood vessels) or other intracranial vascular malformations that are difficult to attach directly by reducing the blood pressure and blood flowto the aneurysm or malformation.

Official code: K.5200. Product type: Aneurysm clip. Official classification: Class 2. An aneurysm clip is a device used to occlude an intracranial aneurysm (a balloonlike sac formed on a blood vessel) to preventit from bleeding or bursting.

Official code: K.5225. Product type: Implanted malleable clip. Official classification: Class 2. An implanted malleableclip is a bent wire or staple that is forcibly closed with a special instrument to occlude an intracranial blood vessel or aneurysm (a balloonlike sac formed on a blood vessel), stop bleeding, or hold tissue or a mechanical device in place in a patient.

Official code: K.5235. Product type: Aversive conditioning device. Official classification: Class 2. An aversive conditioning device is an instrument used to administer an electrical shock or other noxious stimulus to a patient to modify undesirable behavioral characteristics.

Official code: K.5250. Product type: Burr hole cover. Official classification: Class 2. A burr hole cover is a plastic or metal device used to cover or plug holes drilled into the skull during surgery and to reattach cranial bone removed during surgery.

Official code: K.5275. Product type: Nerve cuff. Official classification: Class 2. A nerve cuff is a tubular silicone rubber sheath used to encase a nerve for aid in repairing the nerve (e.g.,to prevent ingrowth of scar tissue) and for capping the end of the nerve to prevent the formation of neuroma (tumors).

Official code: K.5300. Product type: Methyl methacrylate for cranioplasty. Official classification: Class 2. Methyl methacrylate for cranioplasty (skull repair) is a self-curing acrylic that a surgeon uses to repair a skull defect in a patient. At the time of surgery, the surgeon initiates polymerization of the material and forms it into a plate or other appropriate shape to repair the defect.

Official code: K.5320. Product type: Preformed alterable cranioplasty plate. Official classification: Class 2. A preformed alterable cranioplasty plate is a device that is implanted into a patient to repair a skull defect. It is constructed of a material, e.g., tantalum that can be altered or reshaped at the time of surgery without changing the chemical behavior of the material.

Official code: K.5330. Product type: Preformed nonalterable cranioplasty plate. Official classification: Class 2. A preformed nonalterable cranioplasty plate is a device that is implanted in a patient to repair a skull defect and is constructed of a material, e.g., stainless steel or vitallium that cannot be altered or reshaped at the time of surgery without changing the chemical behavior of the material.

Official code: K.5360. Product type: Cranioplasty plate fastener. Official classification: Class 2. A cranioplasty plate fastener is a screw, wire, or other article made of tantalum, vitallium, orstainless steel used to secure a plate to the patient's skull to repair a skull defect.

Official code: K.5500. Product type: Lesion temperature monitor. Official classification: Class 2. A lesion temperature monitor is a device used to monitor the tissue temperature at the site where a lesion (tissue destruction) isto be made when a surgeon uses a radiofrequency (RF) lesion generator and probe.

Official code: K.5550. Product type: Central nervous system fluid shunt and components. Official classification: Class 2. A central nervous system fluid shunt is a device or combination of devices used to divert fluid from the brain orother part of the central nervous system to an internal delivery site or an external receptacle for the purpose of relieving elevated intracranial pressure or fluid volume (e.g., due to hydrocephalus). Components of a central nervous system shunt include catheters, valved catheters, valves, connectors, and other accessory components intended to facilitate use of the shunt or evaluation of a patient with a shunt.

Official code: K.5600. Product type: Neurovascular mechanical thrombectomy device for acute ischemic stroke treatment. Official classification: Class 2. A neurovascular mechanical thrombectomy device for acute ischemic stroke treatment is a device used in the treatment of acute ischemic stroke to improve clinical outcomes. The device is delivered into the neurovasculature with an endovascular approach, mechanically removes thrombus from the body, and restores blood flow in the neurovasculature.

Official code: K.5800. Product type: Cranial electrotheraphy stimulator. Official classification: Class 3. A cranial electrotherapy stimulator is a device that applies electrical current to a patient's head to treat insomnia, depression, or anxiety.

Official code: K.5801. Product type: Computerized behavioral therapy device for psychiatric disorders. Official classification: Class 2. A computerized behavioral therapy device for psychiatric disorders is a only device intended to provide a computerized version of condition-specific behavioral therapy as an adjunct to clinician supervised outpatient treatment to patients with psychiatric conditions. The digital therapy is intended to provide patients access to therapy tools used during treatment sessions to improve recognized treatment outcomes.

Official code: K.5805. Product type: Repetitive transcranial magnetic stimulation system. Official classification: Class 2. A repetitive transcranial magnetic stimulation system is an external device that delivers transcranial repetitive pulsed magnetic fields of sufficient magnitude to induce neural action potentialsin the prefrontal cortex to treat the symptoms of major depressive disorder.

Official code: K.5810. Product type: External functional neuromuscular stimulator. Official classification: Class 2. An external functional neuromuscular stimulator is an electrical stimulator that uses external electrodes for stimulating muscles in the leg and ankle of partially paralyzed patients (e.g., after stroke) to provide flexion of the foot and thus improve the patient's gait.

Official code: K.5820. Product type: Implanted cerebellar stimulator. Official classification: Class 3. An implanted cerebellar stimulator is a device used to stimulate electrically a patient's cerebellar cortex for the treatment of intractable epilepsy, spasticity, and some movement disorders. The stimulator consists of an implanted receiver with electrodes that are placed on the patient's cerebellum and an external transmitter for transmitting the stimulating pulses across the patient's skin to the implanted receiver.

Official code: K.5830. Product type: Implanted diaphragmatic/phrenic nerve stimulator. Official classification: Class 3. An implanted diaphragmatic/phrenic nerve stimulator is a device that provides electrical stimulation of a patient's phrenic nerve to contract the diaphragm rhythmically and produce breathing in patients who have hypoventilation (a state in which an abnormally low amount of air enters the lungs) caused by brain stem disease, high cervical spinal cord injury, or chronic lung disease. The stimulator consists of an implanted receiver with electrodes that are placed around the patient's phrenic nerve and an external transmitter for transmitting the stimulating pulses across the patient's skin to the implanted receiver.

Official code: K.5840. Product type: Implanted. Official classification: Class 3. An implanted intracerebral/subcortical stimulator for pain relief is a device that applies electrical current to subsurface areas of a intracerebral/subcortical stimulator for pain relief patient's brain to treat severe intractable pain. The stimulator consists of an implanted receiver with electrodes that are placed within a patient's brain and an external transmitter for transmitting the stimulating pulses across the patient's skin to theimplanted receiver.

Official code: K.5850. Product type: Implanted spinal cord stimulator for bladder evacuation. Official classification: Class 3. An implanted spinal cord stimulator for bladder evacuation is an electrical stimulator used to empty the bladder of a paraplegic patient who has a complete transection of the spinal cord and who is unableto empty his or her bladder by reflex means or by the intermittent use of catheters. The stimulator consists of an implanted receiver with electrodes that are placed on the conus medullaris portion of the patient's spinal cord and an external transmitterfor transmitting the stimulating pulses across the patient's skin to the implanted receiver.

Official code: K.5860. Product type: Implanted neuromuscular stimulator. Official classification: Class 3. An implanted neuromuscular stimulator is a device that provides electrical stimulation to a patient's peroneal or femoral nerve to cause muscles in the leg to contract, thus improving the gait in a patient with a paralyzed leg. The stimulator consists of an implanted receiver with electrodes that are placed around a patient's nerve and an external transmitter for transmitting the stimulating pulses across the patient's skin to the implanted receiver. The external transmitter is activated by a switch inthe heel in the patient's shoe.

Official code: K.5870. Product type: Implanted peripheral nerve stimulator for pain relief. Official classification: Class 2. An implanted peripheral nerve stimulator for pain relief is a device that is used to stimulate electrically a peripheral nerve in a patient to relieve severe intractable pain. The stimulator consists of an implanted receiver with electrodes that are placedaround a peripheral nerveand an external transmitter for transmitting the stimulating pulses across the patient's skin to the implanted receiver.

Official code: K.5880. Product type: Implanted spinal cord stimulator forpain relief. Official classification: Class 2,3. An implanted spinal cord stimulator for pain relief is a device that isused to stimulate electrically a patient's spinal cord to relieve severe intractable pain. The stimulator consists of an implanted receiver with electrodes that are placed on the patient's spinal cord and an external transmitter for transmitting the stimulating pulses across the patient's skin to the implanted receiver.Classification: (1) Class 2 for devices intended to treat body/limbs cronical or intractable pain, (2) Class 3 for other devices (e.g.,intended to treat pain caused from failed back surgery syndrome).

Official code: K.5890. Product type: Transcutaneous electrical nerve stimulator for pain relief. Official classification: Class 2. A transcutaneous electrical nerve stimulator for pain relief is a device used to apply an electrical current to electrodes ona patient's skin to treat pain.

Official code: K.5892. Product type: External vagal nerve stimulator for headache. Official classification: Class 2. An external vagal nerve stimulator for headache is a device used to apply an electrical current to a patient's vagus nerve through electrodes placed on the skin for the treatment of headache.

Official code: K.5893. Product type: Thermal vestibular stimulator for headache. Official classification: Class 2. The thermal vestibular stimulator for headache is a device used to stimulate the vestibular system by applying thermal waveforms through earpieces placed in a patient's ear canal for the treatment of headache.

Official code: K.5895. Product type: Vibratory counter- stimulation device. Official classification: Class 2. A vibratory counter-stimulation device is a device that provides electrically powered mechanical vibration to improve the quality of sleep in patients with primary Restless Legs Syndrome.

Official code: K.5896. Product type: Percutaneous nerve stimulator for substance use disorders. Official classification: Class 2. A percutaneous nerve stimulator for substance use disorders is a device that stimulates nerves percutaneously to aid in the reduction of withdrawal symptoms associated with substance use disorders.

Official code: K.5897. Product type: External upper limb tremor stimulator. Official classification: Class 2. An external upper limb tremor stimulator is a device which is placed externally on the upper limb and designed to aid in tremor symptom relief of the upper limb.

Official code: K.5900. Product type: Preformed craniosynostosis strip. Official classification: Class 2. A preformed craniosynostosis strip is a plastic strip used to cover bone edges of craniectomy sites (sites where the skull has been cut) to prevent the bone from regrowing in patients whose skull sutures are abnormally fused together.

Official code: K.5910. Product type: Dura substitute. Official classification: Class 2. A dura substitute is a sheet or material that is used to repair the dura mater (the membrane surrounding the brain).

Official code: K.5940. Product type: Electroconvulsive therapy device. Official classification: Class 3. An electroconvulsive therapy device is a device used for treating severe psychiatric disturbances (e.g., severe depression)by inducing in the patient a major motor seizure by applying a brief intense electrical current to the patient's head.

Official code: K.5950. Product type: Artificial embolization device. Official classification: Class 3. A neurovascular embolization device is an intravascular implant intended to permanently occludeblood flow to cerebral aneurysms and cerebral ateriovenous malformations.

Official code: K.5960. Product type: Skull tongs for traction. Official classification: Class 2. Skull tongs for traction is an instrument used to immobilize a patient with a cervical spine injury (e.g.,fracture or dislocation). The device is caliper shaped with tips that penetrate the skin. It is anchored to the skull and has a heavy weight attached to it that maintains, by traction, the patient's position.

Official code: K.5970. Product type: Cranial orthosis. Official classification: Class 2. A cranial orthosis is a device that is intended for medical purposes to apply pressure to prominent regions of an infant's cranium in order to improve cranial symmetry and/or shape in infants from 3 to 18 months of age, with moderate to severe nonsynostotic positional plagiocephaly, including infants with plagiocephalic-, brachycephalic-, and scaphocephalic-shaped heads.

Official code: K.9999. Product type: Others(Neurological Devices) 1,. Official classification: Class 2,3. The products excluded from the above-classification are adopted in this classification and specified by the central competent health authority.

Official code: L.0001. Product type: Chorionic villus sampling set. Official classification: Class 3. The chorionic villus sampling set is a device used to obtain a sample of chorionic tissue through the cervix.

Official code: L.0002. Product type: Uterine manipulator/injector cannula. Official classification: Class 2. The uterine manipulator/injector cannula is a device to deliver contrast media into the uterus and fallopian tubes for the evaluation of the fallopian tubes and/or the uterus.

Official code: L.0004. Product type: Absorbable adhesion barrier. Official classification: Class 3. An absorbable adhesion barrier is used for patients undergoing open gynecologic surgery. This device is intended to reduce the likelihood of developing postoperative adnexal adhesionseither between abdominal wall and lower organs or between the uterus and surrounding tissues in these patients.

Official code: L.1040. Product type: Viscometer for cervical mucus. Official classification: Class 1. A viscometer for cervical mucus is a device that is intended to measure the relative viscoelasticity of cervical mucus collected from a female patient. Measurements of relative viscoelasticity are intended for use as an adjunct in the clinical evaluationof a female with chronic infertility, to determine the time of ovulation and the penetrability of cervical mucus to motile sperm.

Official code: L.1050. Product type: Endocervical aspirator. Official classification: Class 2. An endocervical aspirator is a device designed to remove tissue from the endocervix (mucous membrane lining the canal of the cervix of the uterus) by suction with a syringe, bulb and pipette, or catheter. This device is used to evaluate endocervicaltissue to detect malignant and premalignant lesions.

Official code: L.1060. Product type: Endometrial aspirator. Official classification: Class 2. An endometrial aspirator is a device designed to remove materials from the endometrium (the mucosal lining of the uterus) by suction with a syringe, bulb and pipette, or catheter. This device is used to study endometrial cytology (cells).

Official code: L.1100. Product type: Endometrial brush. Official classification: Class 2. An endometrial brush is a devicedesigned to remove samples of the endometrium (the mucosal lining of the uterus) by brushing its surface. This device is used to study endometrial cytology (cells).

Official code: L.1175. Product type: Endometrial suction curette and accessories. Official classification: Class 2. An endometrial suction curette is a device used to remove material from the uterus and from the mucosal lining of the uterus by scraping and vacuum suction. This device is used to obtain tissue for biopsy or for menstrual extraction. This generic type of device may include catheters, syringes, and tissue filters or traps.

Official code: L.1185. Product type: Endometrial washer. Official classification: Class 2. An endometrial washer is a device used to remove materials from the endometrium (the mucosal lining of the uterus) by washing with water or saline solution and then aspirating with negative pressure. This device is used to study endometrial cytology (cells).

Official code: L.1300. Product type: Uterotubal carbon dioxide insufflator and accessories. Official classification: Class 2. An uterotubal carbon dioxide insufflator and accessories is a device used to test the patency (lack of obstruction) of the fallopian tubes by pressurizing the uterus and fallopian tubes and filling them with carbon dioxide gas.

Official code: L.1425. Product type: Perineometer. Official classification: Class 2. A perineometer is a device consisting of a fluid-filled sack for intravaginal use that is attached to an external manometer. The devices measure the strength of the perineal muscles by offering resistence to a patient's voluntary contractions of these muscles and is used to diagnose and to correct, through exercise, urinary incontinence or sexual dysfunction.

Official code: L.1550. Product type: Amniotic fluid sampler amniocentesis tray. Official classification: Class 1. The amniotic fluid sampler (amniocentesis tray) is a collection of devices used to aspirate amniotic fluid from the amnioticsac via a transabdominal approach. Components of the amniocentesis tray include a disposable 3 inch 20 gauge needle with stylet and a 30 cc. syringe, as well as the various sample collection accessories, such as vials, specimen containers, medium, drapes, etc. The device is used at 16-18 weeks gestation for antepartum diagnosis of certain congenital abnormalities or anytime after 24 weeks gestation when used to assess fetal maturity.

Official code: L.1560. Product type: Fetal blood sampler. Official classification: Class 2. A fetal blood sampler is a device used to obtain fetal blood transcervically through an endoscope by puncturing the fetal skin with a short blade and drawing blood into a heparinized tube. The fetal blood pH is determined and used in the diagnosis of fetal distress and fetal hypoxia.

Official code: L.1600. Product type: Transabdominal amnioscope (fetoscope) and accessories. Official classification: Class 3. A transabdominal amnioscope is a device designed to permitdirect visual examination of the fetus by a telescopic system via abdominal entry. The device is used to ascertain fetal abnormalities, to obtain fetal blood samples, or to obtain fetal tissue. This generic type of device may include the following accessories: trocar and cannula, instruments used through an operating channel or through a separate cannula associated with the amnioscope, light source and cables, and component parts.

Official code: L.1630. Product type: Colposcope. Official classification: Class 2. A colposcope is a device designed to permit direct viewing of the tissues of the vagina and cervix by a telescopic system located outside the vagina. It is used to diagnose abnormalities and select areas for biopsy. This generic type of device may includea light source, cables, and component parts.

Official code: L.1640. Product type: Culdoscope and accessories. Official classification: Class 1,2. Identification: A culdoscope is a device designed to permit direct viewing of the organs within the peritoneum by a telescopic system introduced into the pelvic cavity through the posterior vaginal fornix. It is used to performdiagnostic and surgical procedures on the female genital organs. This generic type of device may include trocar and cannula, instruments used throughan operating channel, scope preheaters, light source and cables, and component parts. Classification:(1)Class 2;(2)Class 1 devices for culdoscope accessories that are not part of a specialized instrument or device delivery system; do not have adapters, connectors, channels, or do not have portals for electrosurgical, laser, or other power sources. Such culdoscope accessory instruments include: lens cleaning brush, biopsy brush, clip applier (without clips), applicator, cannula (without trocar or valves), ligature carrier/needle holder, clamp/hemostat/grasper, curette, instrument guide, ligature passing and knotting instrument, suture needle (without suture), retractor, mechanical (noninflatable), snare, stylet, forceps, dissector, mechanical (noninflatable) scissors, and suction/irrigation probe.

Official code: L.1660. Product type: Transcervical endoscope amnioscopeand accessories. Official classification: Class 2. Atranscervical endoscope is a device designed to permit direct viewing of the fetus and amniotic sac by means of an open tube introduced into the uterus through the cervix. The device may be used to visualize the fetus or amniotic fluid and to sample fetal blood or amniotic fluid. This generic type of device may include obturators, instruments used through an operating channel, light sources and cables, and component parts.

Official code: L.1690. Product type: Hysteroscope and accessories. Official classification: Class 1,2. Identification: A hysteroscope is a deviceused to permit direct viewing of the cervical canal and the uterine cavity by a telescopic system introduced into the uterus through the cervix. It is used to perform diagnostic and surgical procedures other than sterilization. This generic type of devicemay include obturators and sheaths, instruments used through an operating channel, scope preheaters, light sources and cables, and component parts. Classification: (1)Class 2;(2)Class 1 devices for hysteroscope accessories that are not part of a specialized instrument or device delivery system; do not have adapters, connectors, channels, or do not have portals for electrosurgical, laser, or other power sources. Such hysteroscope accessory instruments include: lens cleaning brush, cannula (without trocar orvalves), clamp/hemostat/grasper, curette, instrument guide, forceps, dissector, mechanical (noninflatable), and scissors.

Official code: L.1700. Product type: Hysteroscopic insufflator. Official classification: Class 1,2. Identification: A hysteroscopic insufflator is a device designed to distend the uterus by filling the uterine cavity with a liquid or gas to facilitate viewing with a hysteroscope. Classification: (1) Class 2;(2) Class 1 devices for tubing and tubing/filter fits which only include accessory instruments that are not used to effect intrauterine access, e.g., hysteroscopic introducer sheaths, etc.; and single-use tubing kits used for only intrauterine insufflation.

Official code: L.1710. Product type: Closed loop hysteroscopic insufflator with cutter- coagulator. Official classification: Class 2. A closed loop hysteroscopic insufflator with cutter-coagulator is adevice configured for hysteroscopic insufflation, resection, and coagulation. It is used to perform diagnostic and surgical procedures (i.e., resection and coagulation). This device type contains a closed-loop recirculating fluid management system for thecontrolled delivery of filtered distension fluid. This device type also contains a bipolar radiofrequency device used in conjunction with a hysteroscope for resection and coagulation of intrauterine tissues.

Official code: L.1720. Product type: Gynecologic laparoscope and accessories. Official classification: Class 1,2. Identification: A gynecologic laparoscope is a device used to permit direct viewing of the organs within the peritoneum by a telescopic system introduced through the abdominal wall. It is used to perform diagnostic and surgical procedures on the female genital organs. This generic type of device may include: Trocar and cannula, instruments used through an operating channel, scope preheater, light source and cables, and component parts. Classification: (1) Class 2;(2) Class 1 devices for gynecologic laparoscope accessories that are not part of a specialized instrument or device delivery system, do not have adapters, connector channels, or do not have portals for electrosurgical, lasers, or other power sources. Such gynecologic laparosope accessory instruments include: the lens cleaning brush, biopsy brush, clip applier (without clips), applicator, cannula (without trocar or valves), ligature carrier/needle holder, clamp/hemostat/grasper, curette, instrument guide, ligature passing and knotting instrument,suture needle (without suture), retractor, mechanical (noninflatable), snare, stylet, forceps, dissector, mechanical (noninflatable), scissors, and suction/irrigation probe.

Official code: L.1730. Product type: Laparoscopic insufflator. Official classification: Class 1,2. A laparoscopic insufflator is a device usedto facilitate the use of the laparoscope by filling the peritoneal cavity with gas to distend it. Classification: (1) Class 2; (2) Class 1: Tubing and tubing/filter kits which include accessory instruments that are notused to effect intra-abdominal insufflation (pneumoperitoneum).

Official code: L.2050. Product type: Obstetric data analyzer. Official classification: Class 3. An obstetric data analyzer (fetal status data analyzer) is a device used during labor to analyze electronic signal data obtained from fetal and maternal monitors. The obstetric data analyzer provides clinical diagnosis of fetal status and recommendations for labor management and clinical interventions. This generic type of device may include signal analysis and display equipment, electronic interfaces for other equipment, and power supplies and component parts.

Official code: L.2225. Product type: Obstetric-gynecologic ultrasonic imager. Official classification: Class 2. An obstetric-gynecologic ultrasonic imager is a device designed to transmit and receive ultrasonic energy into and from a female patient by pulsed echoscopy. This device is used to provide avisual representation of some physiological or artificial structure, or of a fetus, for diagnostic purposes during a limited period of time. This generic type of device may include the following: signal analysis and display equipment, electronic interfacesfor other equipment, patient and equipment supports, coupling gel, and component parts. This generic type of device does not include devices used to monitor the changes in some physiological condition over long periods of time.

Official code: L.2600. Product type: Fetal cardiac monitor. Official classification: Class 2. A fetal cardiac monitor is a device used to ascertain fetal heart activity during pregnancy and labor. The device is designedto separate fetal heart signals from maternal heart signals by analyzing electrocardiographic signals (electrical potentialsgenerated during contraction and relaxation of heart muscle) obtained from the maternal abdomen with external electrodes. This generictype of device may include an alarm that signals when the heart rate crosses a preset threshold. This generic type of device includes the "fetal cardiotachometer (with sensors)" and the "fetal electrocardiographic monitor."

Official code: L.2620. Product type: Fetal electroencephalographic. Official classification: Class 3. A fetal electroencephalographic monitor is a device used to detect, measure, and record in graphic form (by means of one or more electrodes placed transcervically on the fetal scalp during labor) the rhythmically varying electrical skin potentials produced by monitorthe fetal brain.

Official code: L.2640. Product type: Fetal phonocardiographic monitor and accessories. Official classification: Class 2. A fetal phonocardiographic monitor is a device designed to detect, measure, and record fetal heart sounds electronically, in graphic form, and noninvasively, to ascertain fetal condition during labor. This generic type of device includes the following accessories: signal analysis and display equipment, patient and equipment supports, and other component parts.

Official code: L.2660. Product type: Fetal ultrasonic monitor and accessories. Official classification: Class 2. A fetal ultrasonic monitor is a device designed to transmit and receive ultrasonic energy into and from the pregnant woman,usually by means of continuous wave (doppler) echoscopy. The device is used to represent some physiological condition or characteristic in a measured value over a period of time (e.g., perinatal monitoring during labor) or in an immediately perceptible form (e.g., use of the ultrasonic stethoscope). This generic type of device may include the following accessories: signal analysis and display equipment, electronic interfaces for other equipment, patient and equipment supports, and component parts. This generic type of device does not include devices used to image some relatively unchanging physiological structure or interpret a physiological condition, but does include devices which may be set to alarm automatically at a predetermined threshold value.

Official code: L.2675. Product type: Fetal scalp circular spiral electrode and applicator. Official classification: Class 2. A fetal scalp circular (spiral) electrode and applicator is a device used to obtain a fetal electrocardiogram during labor and delivery. It establishes electrical contact between fetal skin and an external monitoring device by a shallow subcutaneous puncture of fetal scalp tissue with a curved needle or needles. This generic type of device includes nonreusable spiral electrodes and reusablecircular electrodes.

Official code: L.2685. Product type: Fetal scalp clip electrode and applicator. Official classification: Class 3. A fetal scalp clip electrode and applicator is a device designed to establish electrical contact between fetal skin and an external monitoring device by means of pinching skin tissue with a nonreusable clip. This device is used to obtain a fetal electrocardiogram. This generic type of device may include a clip electrode applicator.

Official code: L.2700. Product type: Intrauterine pressure monitor and accessories. Official classification: Class 2. An intrauterine pressure monitor is a device designed to detect and measure intrauterine and amniotic fluid pressure with a catheter placed transcervically into the uterine cavity. The device is used to monitor intensity, duration, and frequency of uterine contractions during labor. This generic type of device may include the following accessories: signal analysis and display equipment, patient and equipment supports, and component parts.

Official code: L.2720. Product type: External uterine contraction monitor and accessories. Official classification: Class 2. An external uterine contraction monitor (i.e., the tokodynamometer) is a device used to monitor the progress of labor. It measures the duration, frequency, and relative pressure of uterine contractions with a transducer strapped to the maternal abdomen. This generic type of device may include an external pressure transducer, support straps, and other patient and equipment supports.

Official code: L.2730. Product type: Home uterine activity monitor. Official classification: Class 2. A home uterine activity monitor (HUAM) is an electronic system for at home antepartum measurement of uterine contractions, data transmission by telephone to a clinical setting, and for receipt and display of the uterine contraction data at the clinic. The HUAM system comprises a tocotransducer, an at-home recorder, a modem, and a computer and monitor that receive, process, and display data. This device is intended for use in women with a previous preterm delivery to aid in the detection of preterm labor.

Official code: L.2740. Product type: Perinatal monitoring system and accessories. Official classification: Class 2. A perinatal monitoring system is a device used to show graphically the relationship between maternal labor and the fetal heart rate by means of combining and coordinating uterine contraction and fetal heart monitors with appropriate displays of the well-being of the fetus during pregnancy, labor, and delivery. This generic type of device may include the following accessories: Central monitoring system and remote repeaters, signal analysis and display equipment, patient and equipment supports, and component parts.

Official code: L.2800. Product type: Computerized Labor Monitoring System. Official classification: Class 2. A computerized labor monitoring system is a system intended to continuously measure cervical dilation and fetal head descent and provide a display that indicates the progress of labor. The computerized labor monitoring system includes a monitor and ultrasound transducers. Ultrasound transducers are placed on the maternal abdomen and cervix and on thefetal scalp to provide the matrix of measurements used to produce the display.

Official code: L.2900. Product type: Fetal stethoscope. Official classification: Class 1. A fetal stethoscope is a device used for listening to fetal heart sounds. It is designed to transmit the fetal heart sounds not only through sound channels by air conduction, but also through the user's head by tissue conduction into the user's ears. It does not use ultrasonic energy. This device is designed to eliminate noise interference commonly caused by handling conventional stethoscopes.

Official code: L.2960. Product type: Obstetric ultrasonic transducer and accessories. Official classification: Class 2. An obstetric ultrasonic transducer is a device used to apply ultrasonic energy to, and to receive ultrasonic energy from, thebody in conjunction with an obstetric monitor or imager. The device converts electrical signals into ultrasonic energy, and vice versa, by means of an assembly distinct from an ultrasonic generator. This generic type of device may include the following accessories: coupling gel, preamplifiers, amplifiers, signal conditioners with their power supply, connecting cables, and component parts. This generic type of device does not include devices used to generate the ultrasonic frequency electrical signals for application.

Official code: L.2980. Product type: Telethermographic system. Official classification: Class 1,3. A telethermographic system fordiagnostic screening for detection of breast cancer or other uses is an electrically powered device with a detector that is intended to measure, without touching the patient's skin, the self-emanating infrared radiation that reveals the temperature variations of the surface of the body. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories. Classification: (1) Class 1 devices intended for adjunctive diagnostic screening for detection of breast cancer or other uses. (2)Class 3 devices for use alone in diagnostic screening for detection of breast cancer or other use.

Official code: L.2982. Product type: Liquid crystal thermographic system. Official classification: Class 1,3. (a)A nonelectrically powered or an AC-powered liquid crystal thermographic system intended for adjunctive use in diagnostic screening for detection of breast cancer or other uses -(1)Identification. A nonelectrically powered or an AC-powered liquid crystal thermographic system intended for use as an adjunct to physical palpation or mammography in diagnostic screening for detection of breast cancer or other uses is a nonelectrically powered or an AC-powered device applied to the skin that displays the color patterns of heat sensitive cholesteric liquid crystals that respond to temperature variations of the surface of the body. This generic type of device may include patient and equipment supports, a means to ensure thermal contact between the patient's skin and the liquid crystals, component parts, and accessories. (2) Classification. Class 1. (b) A nonelectrically powered or an AC-powered liquid crystal thermographic system intended for use alone in diagnostic screening for detection of breast cancer or other uses-(1) Identification: A nonelectrically powered or an AC-powered liquid crystal thermographic system intended for use as the sole diagnostic screening tool for detection of breast cancer or other uses is a nonelectrically powered or an AC-powered device applied to the skin that displays the color patterns ofheat sensitive cholesteric liquid crystals that respond to temperature variations of the surface of the body. This generic type of device may include image display and recording equipment, patient and equipment supports, a means to ensure thermal contactbetween the patient's skin and the liquid crystals, component parts, and accessories. (2) Classification: Class 3.

Official code: L.3200. Product type: Cervical drain. Official classification: Class 2. A cervical drain is a device designed to provide an exit channel for draining discharge from the cervix after pelvic surgery.

Official code: L.3575. Product type: Vaginal pessary. Official classification: Class 2. A vaginal pessary is a removable structure placed in the vagina to support the pelvic organs and is used to treat conditionssuch as uterine prolapse (falling down of uterus), uterine retroposition (backward displacement), or gynecologic hernia.

Official code: L.3650. Product type: Fallopian tube prosthesis. Official classification: Class 2. A fallopian tube prosthesis is a device designed to maintain the patency (openness) of the fallopian tube and is used after reconstructive surgery.

Official code: L.3900. Product type: Vaginal stent. Official classification: Class 2. A vaginal stent is a device used to enlarge the vagina by stretching, or to support the vagina and to hold a skin graft after reconstructive surgery.

Official code: L.4050. Product type: Gynecologic laparoscopic power morcellation containment system. Official classification: Class 2. A gynecologic laparoscopic power morcellation containment system is a device consisting of an instrument port and tissue containment method that creates a working space allowing for direct visualization during a power morcellation procedure following a laparoscopic procedure for the excision of benign gynecologic tissue that is not suspected to contain malignancy.

Official code: L.4100. Product type: Endoscopic electrocautery and accessories. Official classification: Class 2. An endoscopic electrocautery is a device used to perform female sterilization under endoscopic observation. It is designed to coagulate fallopian tube tissue with a probe heated by low-voltage energy. This generic type of device may include the following accessories: electrical generators, probes, and electrical cables.

Official code: L.4120. Product type: Gynecologic electrocautery and accessories. Official classification: Class 2. A gynecologic electrocauteryis a device designed to destroy tissue with high temperatures by tissue contact with an electrically heated probe. It is used to excise cervical lesions, perform biopsies, or treat chronic cervicitis under direct visual observation. This generic type of device may include the following accessories: an electrical generator, a probe, and electrical cables.

Official code: L.4150. Product type: Bipolar endoscopic coagulator-cutter and accessories. Official classification: Class 2. A bipolar endoscopic coagulator-cutter is a device used to perform female sterilization andother operative procedures under endoscopic observation. It destroys tissue with high temperatures by directing a high frequency electrical current through tissue between two electrical contacts of a probe. This generic type of device may include the following accessories: an electrical generator, probes, and electrical cables.

Official code: L.4160. Product type: Unipolar endoscopic coagulator-cutter and accessories. Official classification: Class 2. A unipolar endoscopic coagulator-cutter is a device designed to destroy tissue with high temperatures by directing a high frequency electrical current through the tissue between an energized probe and a grounding plate. It is used in female sterilization and in other operative procedures under endoscopic observation. This generic type of device may include the following accessories: an electrical generator, probes and electrical cables, and a patient grounding plate. This generic type of device does not include devices used to perform female sterilization under hysteroscopic observation.

Official code: L.4250. Product type: Expandable cervical dilator. Official classification: Class 3. An expandable cervical dilator is an instrument with two handles and two opposing blades used manually to dilate (stretch open) the cervical os.

Official code: L.4260. Product type: Hygroscopic Laminaria cervical dilator. Official classification: Class 2. A hygroscopic laminaria cervical dilator is a device designed to dilate (stretch open) the cervical os.This device shall expand to several times its original diameter by absorbing water from the cervix over a few hours (usually less than 24 hours). This device contains hygroscopic laminaria and synthetic moisture-absorbing materials.

Official code: L.4270. Product type: Vibratory cervical dilators. Official classification: Class 3. A vibratory cervical dilator is a device designed to dilate the cervical os by stretching it with a power-driven vibrating probe head. The device is used to gain access to the uterus or to induceabortion, but is not to be used during labor when a viable fetus is desired or anticipated.

Official code: L.4340. Product type: Fetal vacuum extractor. Official classification: Class 2. A fetal vacuum extractor is a device used to facilitate delivery. The device enables traction to be applied to the fetal head (in the birth canal) by means of a suction cup attached to the scalp and is powered by an external vacuum source. This generic type of device may include the cup, hosing, vacuum source, and vacuum control.

Official code: L.4350. Product type: Fetal head elevator. Official classification: Class 2. A fetal head elevator isa device consisting of a mechanism that elevates the fetal head to facilitate delivery during a Caesarean section.

Official code: L.4400. Product type: Obstetric forceps. Official classification: Class 2. An obstetric forceps is a device consisting of two blades, with handles, designed to grasp and apply traction tothe fetal head in the birth passage and facilitate delivery.

Official code: L.4500. Product type: Obstetric fetal destructive instrument. Official classification: Class 2. An obstetric fetal destructive instrument is a device designed to crush or pull the fetal body to facilitate the delivery ofa dead or anomalous (abnormal) fetus. This generic type of device includes the cleidoclast, cranioclast, craniotribe, and destructive hook.

Official code: L.4520. Product type: Obstetric-gynecologic general manual instrument. Official classification: Class 1. An obstetric-gynecologic general manual instrument is one of a group of devicesused to perform simple obstetric and gynecologic manipulative functions. This generic type of device consists of the following:(1) An episiotomy scissors is a cutting instrument, with two opposed shearing blades, used for surgical incision of the vulvar orifice for obstetrical purposes.(2) A fiberoptic metal vaginal speculum is a metal instrument, with fiberoptic light, used to expose and illuminate the interior of the vagina.(3) Ametal vaginal speculum is a metal instrument used to expose the interior ofthe vagina.(4) An umbilical scissors is a cutting instrument, with two opposed shearing blades, used to cut the umbilical cord.(5) A uterine clamp is an instrument used to hold the uterusby compression.(6) A uterine packer is an instrument used to introduce dressing into the uterus or vagina.(7) A vaginal applicator is an instrument used to insert medication into the vagina.(8) A vaginal retractor is an instrument used to maintain vaginal exposure by separating the edges of the vagina and holding back thetissue.(9) A gynecological fibroid hook is an instrument used to exert traction upon a fibroid.(10) A pelvimeter (external) is an instrument used to measure the external diameters of the pelvis.

Official code: L.4530. Product type: Obstetric-gynecologic specialized manual instrument. Official classification: Class 1,2. (a)An obstetric-gynecologic specialized manual instrument is one of a group of devices used during obstetric-gynecologic procedures to perform manipulative diagnostic and surgical functions (e.g., dilating, grasping, measuring, and scraping), where structural integrity is the chief criterion of device performance. This type of device consists of the following:(1) An amniotome is an instrument used to rupture the fetal membranes.(2) A circumcision clamp is an instrument used to compress the foreskin of thepenis during circumcision of a male infant.(3) An umbilical clamp is an instrument used to compress the umbilical cord.(4) A uterine curette is an instrument used to scrape and remove material from the uterus.(5) A fixed-size cervical dilator is any of a series of bougies of various sizes used to dilate the cervical os by stretching the cervix.(6) A uterine elevator is an instrument inserted into the uterus used to lift and manipulate the uterus.(7) A gynecological surgical forceps is an instrument with twoblades and handles used to pull, grasp, or compress during gynecological examination.(8) A cervical cone knife is a cutting instrument used to excise and remove tissue from the cervix.(9) A gynecological cerclage needle is a looplike instrument used to suture the cervix.(10) A hook-type contraceptive intrauterine device (IUD) remover is an instrument used to remove an IUD from the uterus.(11) A gynecological fibroid screw is an instrument used to hold onto a fibroid.(12) A uterine sound is an instrument used to determine the depth of the uterus by inserting it into the uterine cavity.(13) A cytological cervical spatula is a blunt instrument used to scrape and remove cytological material from the surface of the cervix or vagina.(14) A gynecological biopsy forceps is an instrument with two blades and handles used for gynecological biopsy procedures.(15) A uterine tenaculum is a hooklike instrument used to seize and hold the cervix or fundus.(16) An internal pelvimeter is an instrument used within the vagina tomeasure the diameter and capacity of the pelvis.(17) A nonmetal vaginal speculum is a nonmetal instrument used to expose the interior of the vagina.(18) A fiberoptic nonmetal vaginal speculum is a nonmetal instrument, with fiberoptic light, used to expose and illuminate the interior of the vagina. (b)Classification: (1) Class 2;(2) Class 1 devices for the amniotome, uterine curette, cervical dilator (fixed-size bougies), cerclage needle, IUD remover, uterine sound, and gynecological biopsy forceps.

Official code: L.4550. Product type: Gynecologic surgical laser. Official classification: Class 2. A gynecologic surgical laser is a continuous wave carbon dioxide laser designed to destroy tissue thermally or to remove tissue by radiant light energy. The device is used only in conjunction with a colposcope as part of a gynecological surgical system. A colposcope is a magnifying lens system used to examine the vagina and cervix.

Official code: L.4900. Product type: Obstetric table and accessories. Official classification: Class 2. An obstetric table is a device with adjustable sections designed to support a patient in the various positions required during obstetric and gynecologic procedures. This generic type of device may include the following accessories: patient equipment, support attachments, and cabinets for warming instruments and disposing of wastes.

Official code: L.5050. Product type: Metreurynter-balloon abortion system. Official classification: Class 3. A metreurynter-balloon abortion system is a device used to induce abortion. The device is inserted into the uterine cavity, inflated, and slowly extracted. The extraction of the balloon from the uterus causes dilation of the cervical os.This generic type of device may include pressure sources and pressure controls.

Official code: L.5070. Product type: Vacuum abortion system. Official classification: Class 2. A vacuum abortion system is a device designed to aspirate transcervically the products of conception or menstruation from the uterus by using acannula connected to a suction source. This device is used for pregnancy termination or menstrual regulation. This type of device may include aspiration cannula, vacuum source, and vacuum controller.

Official code: L.5100. Product type: Obstetric anesthesia set. Official classification: Class 2. An obstetric anesthesia set is an assembly of antiseptic solution, needles, needle guides, syringes, and other accessories, intended for use with an anesthetic drug. This device is used to administer regional blocks (e.g., paracervical, uterosacral, and pudendal) that may be used during labor, delivery, or both.

Official code: L.5200. Product type: Hemorrhoid prevention. Official classification: Class 2. A hemorrhoid prevention pressure wedge provides mechanical support to the perianal region during the labor and delivery process. pressure wedgeExternal mechanical support of the perianal region is intended to help prevent the occurrence of external hemorrhoids associated with vaginal childbirth. Classification. Class 2.

Official code: L.5210. Product type: Pressure wedge for the reduction of cesarean delivery. Official classification: Class 2. A pressure wedge for the reduction of cesarean deliveryis a device that provides external mechanical support to the perianal region during the labor and vaginal delivery process. External mechanical support of the perianal region is intended to help reducethe occurrence of cesarean delivery.

Official code: L.5225. Product type: Abdominal decompression chamber. Official classification: Class 3. An abdominal decompression chamber is a hoodlike device used to reduce pressure on the pregnant patient's abdomen for the relief of abdominal pain during pregnancy or labor.

Official code: L.5250. Product type: Cervical cap. Official classification: Class 2. A cervical cap is a flexible cuplike receptacle that fits over the cervix to collect menstrual flow or to aid artificial insemination. This generic type of device is not for contraceptive use.

Official code: L.5300. Product type: Condom. Official classification: Class 2. A condom is a sheath which completely covers the penis with a closely fitting membrane. The condom is used for contraceptive and for prophylactic purposes (preventing transmission of sexually transmitted infections). The device may also be used to collect semen to aid in the diagnosis of infertility. The device may contain lubricants compatible for use with condoms.

Official code: L.5310. Product type: Condom with spermicidal lubricant. Official classification: Class 2. A condom with spermicidal lubricant is a sheath which completely covers the penis with a closely fitting membrane with a lubricant that contains a spermicidal agent, Nonoxynol-9.This condom is used for contraceptive and prophylactic purposes (preventing sexually-transmitted diseases).

Official code: L.5320. Product type: Glans sheath. Official classification: Class 3. A glans sheath device is a sheath which covers only the glans penis or part thereof and may also cover the area in the immediate proximity thereof, the corona and frenulum, but not the entire shaft of the penis. It is indicated only for the prevention ofpregnancy and not for the prevention of sexually-transmitted diseases.

Official code: L.5330. Product type: Multiple-use female condom. Official classification: Class 3. A multiple-use female condom is a sheath-like device that lines the vaginal wall and is inserted into the vagina prior to the initiation of coitus. At the conclusion of coitus, the device can be reused. It is indicated for contraception and prophylactic (preventing the transmission of sexually transmitted infections) purposes.

Official code: L.5340. Product type: Single-use internal condom. Official classification: Class 2. A single-use internal condom is an over-the-counter sheath-like device that lines the vaginal or anal wall and is inserted into the vagina or anus prior to the initiation of coitus. At the conclusion of coitus, it is removed and discarded. It is indicated for contraception and/or prophylactic (preventing the transmission of sexually transmitted infections) purposes.

Official code: L.5350. Product type: Contraceptive diaphragm and accessories. Official classification: Class 2. A contraceptive diaphragm is a closely fitting membrane placed between the posterior aspect of the pubic bone and the posterior vaginal fornix. The device covers the cervix completely and is used with a spermicide to prevent pregnancy. This generic type of device may include an introducer.

Official code: L.5360. Product type: Contraceptive intrauterine device (IUD) and introducer. Official classification: Class 3. A contraceptive intrauterine device (IUD) is a device used to prevent pregnancy. The device is placed high in the uterine fundus with a string extending from the device through the cervical os into the vagina. This generic type of device includes the introducer, but does not include contraceptive IUD's that function by drug activity.

Official code: L.5380. Product type: Contraceptive tubal occlusion device (TOD) and introducer. Official classification: Class 3. A contraceptive tubal occlusion device (TOD) and introducer is a device designed to close a fallopian tube with a mechanical structure, e.g., a band or clip on the outside of the fallopian tube or a plug or valve on the inside. The devices are used to prevent pregnancy.

Official code: L.5390. Product type: Perineal heater. Official classification: Class 2. A perineal heater is a device designed to apply heat directly by contact, or indirectly from a radiant source, to the surfaceof the perineum (the area between the vulva and the anus) and is used to soothe or to help heal the perineum after an episiotomy (incision of the vulvar orifice for obstetrical purposes).

Official code: L.5400. Product type: Menstrual cup. Official classification: Class 2. A menstrual cup is a receptacle placed in the vagina to collect menstrual flow.

Official code: L.5460. Product type: Scented or scented deodorized menstrual tampon. Official classification: Class 2. A scented or scented deodorized menstrual tampon is a device that is a plug made of cellulosic or synthetic material that is inserted into the vagina and used to absorb menstrual or other vaginal discharge. It has scent (i.e., fragrance materials) added for aesthetic purposes (scented menstrual tampon) or for deodorizing purposes (scented deodorized menstrual tampon). This generic type of device does not include menstrual tampons treated with added antimicrobial agents or other drugs.

Official code: L.5470. Product type: Unscented menstrual tampon. Official classification: Class 2. An unscented menstrual tampon is a device that is a plug made of cellulosic or synthetic material that is inserted into the vagina and used to absorb menstrual or other vaginal discharge. This generic type of device does not include menstrual tampons treated with scent (i.e., fragrance materials) or those with added antimicrobial agents or other drugs.

Official code: L.5900. Product type: Therapeutic vaginal douche apparatus. Official classification: Class 1,2. Identification: A therapeutic vaginal douche apparatus is a device that is a bag or bottle with tubing and a nozzle. The apparatus does not include douche solutions. The apparatus is intended and labeled for use in the treatment of medical conditions except it is not for contraceptive use. After filling the therapeutic vaginal douche apparatus with asolution, the patient uses the device to direct a stream of solution into the vaginal cavity. Classification:(1) Class 2;(2) Class 1 devices operated by gravity.

Official code: L.5920. Product type: Vaginal insufflator. Official classification: Class 1. A vaginal insufflator is a device used to treat vaginitis by introducing medicated powder from a hand-held bulb into the vagina through an open speculum.

Official code: L.5940. Product type: Powered vaginal muscle stimulator for therapeutic use. Official classification: Class 3. A powered vaginal muscle stimulator is an electrically powered device designed to stimulate directlythe muscles of the vagina with pulsating electrical current. This device is intended and labeled for therapeutic use in increasing muscular tone and strength in the treatment of sexual dysfunction. This generic type of device does not include devices used to treat urinary incontinence.

Official code: L.5960. Product type: Genital vibrator for therapeutic use. Official classification: Class 2. A genital vibrator for therapeutic use is an electrically operated device intended and labeled for therapeutic use in the treatment of sexual dysfunction or as an adjunct to Kegel's exercise (tightening of the muscles of the pelvic floor to increase muscle tone).

Official code: L.5970. Product type: Clitoral engorgement device. Official classification: Class 2. A clitoral engorgement device is designed to apply a vacuum to the clitoris. It is intended for use in the treatment of female sexual arousal disorder.

Official code: L.5980. Product type: Surgical mesh for transvaginal pelvic organ prolapse repair. Official classification: Class 3. Surgical mesh for transvaginal pelvic organ prolapse repair is a device intended to reinforce soft tissue in the pelvic floor. This device is a porous implant that is made of synthetic material, non-synthetic material, or a combination of synthetic and non- synthetic materials.

Official code: L.6100. Product type: Assisted reproduction needles. Official classification: Class 2. Assisted reproduction needles are devices used in in vitro fertilization (IVF), gamete intrafallopian transfer (GIFT), or other assisted reproduction procedures to obtain gametes from the body or introduce gametes, zygote(s), preembryo(s) and/or embryo(s) into the body. This generic type of device may include a single or double lumen needle and component parts, including needle guides, such as those used with ultrasound.

Official code: L.6110. Product type: Assisted reproduction catheters. Official classification: Class 2. Assisted reproduction catheters are devices used in in vitro fertilization (IVF), gamete intrafallopian transfer (GIFT), or other assisted reproduction procedures to introduce or remove gametes, zygote(s), preembryo(s), and/or embryo(s) into or from the body. This generic type of device may include catheters, cannulae, introducers, dilators, sheaths, stylets, and component parts.

Official code: L.6120. Product type: Assisted reproduction accessories. Official classification: Class 2. Assisted reproduction accessories are a group of devices used during assisted reproduction procedures, in conjunction with assisted reproduction needles and/or assisted reproduction catheters, to aspirate, incubate, infuse, and/or maintain temperature. This generic type of device may include:(1) Powered aspiration pumps used to provide low flow, intermittent vacuum for the aspiration of eggs (ova).(2) Syringe pumps (powered or manual) used to activate a syringe to infuse or aspirate small volumes of fluid during assisted reproduction procedures.(3) Collection tube warmers, used to maintain the temperature of egg (oocyte) collection tubes at ornear body temperature. A dish/plate/microscope stage warmer is a device used to maintain the temperature of the egg (oocyte) during manipulation.(4) Embryo incubators, used to store and preserve gametes and/or embryos at or near body temperature.(5) Cryopreservation instrumentation and devices, used to contain, freeze, and maintain gametes and/or embryos at an appropriate freezing temperature.

Official code: L.6130. Product type: Assisted reproduction microtools. Official classification: Class 2. Assisted reproduction microtools are pipettes or other devices used in the laboratory to denude, micromanipulate, hold, or transfer human gametes or embryos for assisted hatching, intracytoplasmic sperm injection (ICSI), or other assisted reproduction methods.

Official code: L.6140. Product type: Assisted reproduction micropipette fabrication instruments. Official classification: Class 2. Assisted reproduction micropipette fabrication devices are instruments intended to pull, bevel, or forge a micropipette or needle for intracytoplasmic sperm injection (ICSI), in vitro fertilization (IVF) or other similar assisted reproduction procedures.

Official code: L.6150. Product type: Assisted reproduction micromanipulators and microinjectors. Official classification: Class 2. Assisted reproduction micromanipulators are devices intended to control the position of an assisted reproduction microtool. Assisted reproduction microinjectors are any device intended to control aspiration or expulsion of the contents of an assisted reproduction microtool.

Official code: L.6160. Product type: Assisted reproduction labware. Official classification: Class 2. Assisted reproduction labware consists of laboratory equipment or supplies intended to prepare, store, manipulate, or transfer human gametes or embryos for in vitro fertilization (IVF), gamete intrafallopian transfer (GIFT), or other assisted reproduction procedures. These include syringes, IVF tissue culture dishes, IVF tissue culture plates, pipette tips, dishes, plates, and other vessels that come into physical contact with gametes, embryos or tissue culture media.

Official code: L.6165. Product type: Intravaginal culture system. Official classification: Class 2. An intravaginal culture system is a device intended for preparing, holding, and transferring human gametes or embryos during intravaginal in vitro fertilization or intravaginal culture procedures.

Official code: L.6170. Product type: Assisted reproduction water. Official classification: Class 2. Assisted reproduction water purification systems are devices specifically intended to generate high quality, sterile, pyrogen-free and water purification systems water for reconstitution of media used for aspiration, incubation, transfer or storage of gametes or embryos for in vitro fertilization (IVF) or other assisted reproduction procedures. These devices may also be intended as the final rinse for labware or other assisted reproduction devices that will contact the gametes or embryos. Thesedevices also include bottled water ready for reconstitution available from a vendor that is specifically intended for reconstitution of media used for aspiration, incubation, transfer,or storage of gametes or embryos for IVF or other assisted reproduction procedures.

Official code: L.6180. Product type: Reproductive media and supplements. Official classification: Class 2. Reproductive media and supplement are products that are used for assisted reproduction procedures. Media include liquid and powder versions of various substances that come in direct physical contact with human gametes or embryos (including water, acid solutions used to treat gametes or embryos, rinsing solutions, sperm separation media, supplements, or oil used to cover themedia) for the purposes of preparation, maintenance, transfer or storage. Supplements are specific reagents added to media to enhance specific properties of the media (e.g., proteins, sera, antibiotics, etc.).

Official code: L.6190. Product type: Assisted reproductive microscopes and microscope accessories. Official classification: Class 1. Assisted reproduction microscopes and microscope accessories (excluding microscope stage warmers, which are classified under assisted reproduction accessories) are optical instruments used to enlarge images of gametes or embryos. Variations of microscopes and accessories used for these purposes would include phase contrast microscopes, dissecting microscopes and inverted stage microscopes.

Official code: L.6195. Product type: Assisted Reproduction Embryo Image Assessment System. Official classification: Class 2. An Assisted Reproduction Embryo Image Assessment System is a device that is designed to obtain and analyzelight microscopy images of developing embryos. This device provides information to aid in the selection of embryo(s) for transfer when there are multiple embryos deemed suitable for transfer or freezing.

Official code: L.6200. Product type: Assisted reproduction laser system. Official classification: Class 2. The assisted reproduction laser system is a device that images, targets, and controls the power and pulse duration of a laser beam used to ablate a small tangential hole in, or to thin, the zona pellucida of an embryo for assisted hatching or other assisted reproduction procedures.

Official code: L.9999. Product type: Others(Obstetrical and Gynecological Devices) 1,. Official classification: Class 2,3. The products excluded from the above-classification are adopted in this classification and specified by the central competent health authority.

Official code: M.0001. Product type: Ophthalmic excimer laser system. Official classification: Class 3. Ophthalmic excimer laser system is intended for corneal ablation (i.e., photorefractive keratectomy) and other ophthalmologic procedures (e.g., surgical creation of a communication between the lacrimal sac and the nasal cavity). It includes a light source, controls/foot-switch, monitoring system, and probes. This system commonly connects to a slit lamp or non-contact ophthalmoscope by an optical fiber.

Official code: M.0002. Product type: Endocapsular ring. Official classification: Class 3. An endocapsular ring is an ophthalmic device for placement into the capsular bag. It may be used for the stabilization of lens capsular bag when zonules are broken or missing. Examples are capsular tension rings.

Official code: M.0003. Product type: Lacrimal Punctum Plug. Official classification: Class 2. A lacrimal punctum plug is an ophthalmological device designed to be insertedthrough the punctal opening into the canaliculus in order to block tear drainage through the lacrimal drainage system.

Official code: M.1040. Product type: Ocular esthesiometer. Official classification: Class 1. An ocular esthesiometer is a device, such as a single-hair brush, intended to touch the cornea to assess corneal sensitivity.

Official code: M.1050. Product type: Adaptometer (biophotometer). Official classification: Class 1. An adaptometer (biophotometer) is an AC-powered device that provides a stimulating light source which has various controlled intensities intended to measure the time required for retinal adaptation(regeneration of the visual purple) and the minimum light threshold.

Official code: M.1070. Product type: Anomaloscope. Official classification: Class 1. An anomaloscope is an AC-powered device intended to test for anomalies of color vision by displaying mixed spectral lines to be matched by the patient.

Official code: M.1090. Product type: Haidinger brush. Official classification: Class 1. A Haidinger brush is an AC-powered device that provides two conical brus-hlike images with apexes touching which are viewed by the patient through a Nicol prism and intended to evaluate visual function. It may include a component for measuring macular integrity.

Official code: M.1100. Product type: Retinopathy detection software device. Official classification: Class 2. A retinopathy detection software device is a software device that incorporates algorithms to evaluate ophthalmic images for diagnostic screening to identify retinal diseases or conditions.

Official code: M.1120. Product type: Ophthalmic camera. Official classification: Class 2. An ophthalmic camera is an AC-powered device intended to take photographs of the eye and the surrounding area.

Official code: M.1140. Product type: Ophthalmic chair. Official classification: Class 1. An ophthalmic chair is an AC-powered or manual device with adjustable positioning in which a patient is to sit or recline during ophthalmological examination or treatment.

Official code: M.1160. Product type: Color vision plate illuminator. Official classification: Class 1. A color vision plate illuminator is an AC-powered device that is a lamp intended to properly illuminate color vision testing plates. It may include a filter.

Official code: M.1200. Product type: Optokinetic drum. Official classification: Class 1. An optokinetic drum is a drum-like device covered with alternating white and dark stripes or pictures that can be rotated on its handle. The device is intended to elicit and evaluate nystagmus (involuntary rapid movement of the eyeball) in patients.

Official code: M.1220. Product type: Corneal electrode. Official classification: Class 2. A corneal electrode is an AC-powered device, usually part of a special contact lens, intended to be applied directly to the cornea to provide data showing the changes in electrical potential in the retina after electroretinography (stimulation by light).

Official code: M.1250. Product type: Euthyscope. Official classification: Class 1,2. A euthyscope is a device that is a modified AC-powered or battery-powered ophthalmoscope (a perforated mirror device intended to inspect the interior of theeye) that projects a bright light encompassing an arc of about 30 degrees onto the fundus of the eye. The center of the light bundle is blocked by a black disk covering the fovea (the central depression of the macular retinae where only cones are presentand blood vessels are lacking). The device is intended for use in the treatment of amblyopia (dimness of vision without apparent disease of the eye). Classification: (1) Class 1 for the battery-powered device. Class 2 for the AC-powered device.

Official code: M.1270. Product type: Exophthalmometer. Official classification: Class 1. An exophthalmometer is a device, such as a ruler, gauge, or caliper, intended to measure the degree of exophthalmos (abnormal protrusion of the eyeball).

Official code: M.1290. Product type: Ophthalmic Fixation device. Official classification: Class 1. A fixation device is an AC-powered device intended for use as a fixation target for the patient during ophthalmological examination. The patient directs his or her gaze so that the visual image of the object falls on the fovea centralis (the center of the macular retina of the eye.)

Official code: M.1300. Product type: Afterimage flasher. Official classification: Class 2. An afterimage flasher is an AC-powered light that automatically switches on and off to allow performance of an afterimage test in which the patient indicates the positions of afterimages after the light is off. The device is intended to determine harmonious/anomalous retinal correspondence (the condition in which corresponding points on the retina have the same directional value).

Official code: M.1320. Product type: Fornixscope. Official classification: Class 1. A fornixscope is a device intended to pull back and hold open the eyelid to aid examination of the conjunctiva.

Official code: M.1340. Product type: Haploscope. Official classification: Class 1. A haploscope is an AC-powered device that consists of two movable viewing tubes, each containing a slide carrier, a low-intensity light source for the illumination of the slides, and a high-intensity light source for creating afterimages. The device is intended to measure strabismus (eye muscle imbalance), to assess binocular vision (use of both eyes to see), and to treat suppression and amblyopia (dimness of vision without any apparent disease of the eye).

Official code: M.1342. Product type: Strabismus detection device. Official classification: Class 2. A strabismus detection device is a device designed to simultaneously illuminate both eyes with polarized light for automated detection of strabismus by analyzing foveal birefringence properties.

Official code: M.1350. Product type: Keratoscope. Official classification: Class 1. A keratoscope is an AC-powered or battery-powered device intended to measure and evaluate the corneal curvature of the eye. Lines and circles within the keratoscope are used to observe the corneal reflex. This generic type of device includes the photokeratoscope which records corneal curvature by taking photographs of the cornea.

Official code: M.1360. Product type: Visual field laser instrument. Official classification: Class 2. A visual field laser instrument is an AC-powered device intended to provide visible laser radiation that produces an interference pattern on the retina to evaluate retinal function.

Official code: M.1375. Product type: Bagolini lens. Official classification: Class 1. A Bagolini lens is a device that consists of a plane lens containing almost imperceptible striations that do not obscure visualization of objects. The device is placed in a trial frame and intended to determine harmonious/anomalous retinal correspondence (a condition in which corresponding points on the retina have the same directional values).

Official code: M.1380. Product type: Diagnostic condensing lens. Official classification: Class 1. A diagnostic condensing lens is a device used in binocular indirect ophthalmoscopy (a procedure that produces an inverted or reversed direct magnified image of the eye) intended to focus reflected light from the fundus of the eye.

Official code: M.1385. Product type: Polymethylmethacrylate (PMMA) diagnostic contact lens. Official classification: Class 2. A polymethylmethacrylate (PMMA) diagnostic contact lens is a device that is a curved shell of PMMA intended to be applied for a short period of time directly on the globe or cornea of the eye for diagnosis or therapy of intraocular abnormalities.

Official code: M.1390. Product type: Flexible diagnostic Fresnel lens. Official classification: Class 1. A flexible diagnostic Fresnel lens is a device that is a very thin lens which has its surface a concentric series of increasingly refractive zones. The device is intended to be applied to the back of the spectacle lenses of patients with aphakia (absence of the lens of the eye).

Official code: M.1395. Product type: Diagnostic Hruby fundus lens. Official classification: Class 1. A diagnostic Hruby fundus lens is a device that is a 55 diopter lens intended for use in the examination of the vitreous bodyand the fundus of the eye under slitlamp illumination and magnification.

Official code: M.1400. Product type: Maddox lens. Official classification: Class 1. A Maddox lens is a device that is a series of red cylinders that change the size, shape, and color of an image. The device isintended to be handheld or placed in a trial frame to evaluate eye muscle dysfunction.

Official code: M.1405. Product type: Ophthalmic trial lens set. Official classification: Class 1. An ophthalmic trial lens set is a device that is a set of lenses of various dioptric powers intended to be handheld or inserted in a trial frame for vision testing to determine refraction.

Official code: M.1410. Product type: Ophthalmic trial lens clip. Official classification: Class 1. An ophthalmictrial lens clip is a device intended to hold prisms, spheres, cylinders, or occluders on a trial frame or spectacles for vision testing.

Official code: M.1435. Product type: Maxwell spot. Official classification: Class 1. A Maxwell spot is an AC-powered device that is a light source with a red and blue filter intended to test macular function.

Official code: M.1450. Product type: Corneal radius measuring device. Official classification: Class 1. A corneal radius measuring device is an ophthalmic device that is intended to measure corneal curvature.This device measures corneal curvature through projecting the corneal image to handheld eyepiece or magnifying glass. The item doesnot include keratometer.

Official code: M.1460. Product type: Stereopsis measuring instrument. Official classification: Class 1. A stereopsis measuring instrument is a device intended to measure depth perception by illumination of objects placed on different planes.

Official code: M.1510. Product type: Eye movement monitor. Official classification: Class 2. An eye movement monitor is an AC-powered device with an electrode intended to measure and record ocular movements.

Official code: M.1570. Product type: Ophthalmoscope. Official classification: Class 2. An ophthalmoscope is an AC-powered or battery-powered device containing illuminationand viewing optics intended to examine the media (cornea, aqueous, lens, and vitreous) and the retina of the eye.

Official code: M.1605. Product type: Perimeter. Official classification: Class 1. A perimeter is an AC-powered or manual device intended to determine the extent of the peripheral visual field of a patient. The device projects light on various points of a curved surface, and the patient indicates whether he or she sees the light.

Official code: M.1630. Product type: AC-powered photostimulator. Official classification: Class 2. An AC-powered photostimulator is an AC-powered device intended to provide light stimulus which allows measurement of retinal or visual function by perceptual or electrical methods (e.g., stroboscope).

Official code: M.1640. Product type: Ophthalmic preamplifier. Official classification: Class 2. An ophthalmic preamplifier is an AC-powered or battery-powered device intended to amplify electrical signals from the eye in electroretinography (recording retinal action currents from the surface of the eyeball after stimulation by light), electrooculography (testing for retinal dysfunction by comparing the standing potential in the front and the back of the eyeball), and electromyography (recording electrical currents generated in active muscle).

Official code: M.1650. Product type: Ophthalmic bar prism. Official classification: Class 1. An ophthalmic bar prism is a device that is a bar composed of fused prisms of gradually increasing strengths intended to measure latent and manifest strabismus (eye muscle deviation) or the power of fusion of a patient's eyes.

Official code: M.1655. Product type: Ophthalmic Fresnel prism. Official classification: Class 1. An ophthalmic Fresnel prism is a device that is a thin plastic sheet with embossed rulings which provides the optical effectof a prism. The device is intended to be applied to spectacle lenses to give a prismatic effect.

Official code: M.1660. Product type: Gonioscopic prism. Official classification: Class 1. A gonioscopic prism is a device that is a prism intended to be placed on the eye to study the anterior chamber. The device may have angled mirrors to facilitate visualization of anatomical features.

Official code: M.1665. Product type: Ophthalmic rotary prism. Official classification: Class 1. An ophthalmic rotary prism is a device with various prismatic powers intended to be handheld and used to measure ocular deviation in patients with latent or manifest strabismus (eye muscle deviation).

Official code: M.1670. Product type: Ophthalmic isotope uptake probe. Official classification: Class 2. An ophthalmic isotope uptake probe is an AC-powered device intended to measure, by a probe which is placed in close proximity to the eye, the uptake of a radioisotope (phosphorus 32) by tumors to detect tumor masses on, around, or within the eye.

Official code: M.1680. Product type: Ophthalmic projector. Official classification: Class 1. An ophthalmic projector is an AC-powered device intended to project an image on a screen for vision testing.

Official code: M.1690. Product type: Pupillograph. Official classification: Class 1. A pupillograph is an AC-powered device intended to measure the pupil of the eye by reflected light and record the responses of the pupil.

Official code: M.1700. Product type: Pupillometer. Official classification: Class 1. A pupillometer is an AC-powered or manual device intended to measure by reflected light the width or diameter of thepupil of the eye.

Official code: M.1750. Product type: Skiascopic rack. Official classification: Class 1. A skiascopic rack is a device that is a rack and a set of attached ophthalmic lenses of various dioptric strengths intended as an aid in refraction.

Official code: M.1760. Product type: Ophthalmic refractometer. Official classification: Class 1. An ophthalmic refractometer is an automatic AC-powered device that consists of a fixation system, a measurement and recording system, and an alignment system intended to measure the refractive power of the eye by measuring light reflexes from the retina.

Official code: M.1770. Product type: Manual refractor. Official classification: Class 1. A manual refractor is a device that is a set of lenses of varous dioptric powers intended to measure the refractive error of the eye.

Official code: M.1780. Product type: Retinoscope. Official classification: Class 1,2. A retinoscope is an AC-powered or battery-powered device intended to measure the refraction of the eye by illuminating the retina and noting the direction of movement of the light on the retinal surface and of the refraction by the eye of the emergent rays. Classification: (1) Class 1 for the DC-powered device. (2) Class 2 for the AC-powered device.

Official code: M.1790. Product type: Nearpoint ruler. Official classification: Class 1. A nearpoint ruler is a device calibrated in centimeters intended to measure the nearpoint of convergence (the point to whichthe visual lines are directed when convergence is at its maximum).

Official code: M.1800. Product type: Schirmer strip. Official classification: Class 1. A Schirmer stripis a device made of filter paper or similar material intended to be inserted under a patient's lower eyelid to stimulate and evaluate formation of tears.

Official code: M.1810. Product type: Tangent screen (campimeter). Official classification: Class 1. A tangent screen (campimeter) is an AC-powered or battery-powered device that is a large square cloth chart with a central mark of fixation intended to map on a flat surface the central 30 degrees of a patient's visual field. This generic type of deviceincludes projection tangent screens, target tangent screens and targets, felt tangent screens, and stereo campimeters.

Official code: M.1850. Product type: AC-powered slitlamp biomicroscope. Official classification: Class 2. An AC-powered slitlamp biomicroscope is an AC-powered device that is a microscope intended for use in eye examination that projects into a patient's eye through a control diaphragm a thin, intense beam of light.

Official code: M.1870. Product type: Stereoscope. Official classification: Class 1. A stereoscope is an AC-powered or battery-powered device that combines the images of two similar objects to produce a three- dimensional appearance of solidity and relief. It is intended to measure the angle of strabismus (eye muscle deviation), evaluate binocular vision (usage of both eyes to see), and guide a patient's corrective exercises of eye muscles.

Official code: M.1905. Product type: Nystagmus tape. Official classification: Class 1. Nystagmus tape is a device that is a long, narrow strip of fabric or other flexible material on which a series of objects are printed. The device is intended to be moved across a patient's field of vision to elicit optokinetic nystagmus (abnormal and irregulareye movements) and to test for blindness.

Official code: M.1910. Product type: Spectacle dissociation test system. Official classification: Class 1. A spectacle dissociation test system is an AC-powered or battery-powered device, such as a Lancaster test system, that consists of a light source and various filters, usually red or green filters, intended to subjectively measure imbalance of ocular muscles.

Official code: M.1925. Product type: Diurnal pattern recorder system. Official classification: Class 2. A diurnal pattern recorder system is a nonimplantable, device incorporating a telemetric sensor to detect changes in ocular dimension for monitoring diurnal patterns of intraocular pressure (IOP) fluctuations.

Official code: M.1930. Product type: Tonometer and accessories. Official classification: Class 2. A tonometer and accessories is a manual device intended to measure intraocular pressure by applying a known force on the globe of the eye and measuring the amount of indentation produced (Schiotz type) or to measure intraocular tension by applanation (applying a small flat disk to the cornea). Accessories for the device may include a tonometer calibrator or a tonograph recording system. The device is intended for use in the diagnosis of glaucoma.

Official code: M.1945. Product type: Transilluminator. Official classification: Class 1,2. A transilluminator is an AC-powered or battery-powered device that is a light source intended to transmit light through tissues to aid examination of patients. Classification: (1) Class 1 battery-powered device. (2) Class 2 AC-powered device.

Official code: M.3100. Product type: Ophthalmic tantalum clip. Official classification: Class 2. An ophthalmic tantalum clip is a malleable metallic device intended to be implanted permanently or temporarily to bring together the edges of a wound to aid healing or prevent bleeding from small blood vessels in the eye.

Official code: M.3130. Product type: Ophthalmic conformer. Official classification: Class 1. An ophthalmic conformer is a device usually made of molded plastic intended to be inserted temporarily between the eyeball and eyelid to maintain space in the orbital cavity and prevent closure or adhesions during the healing process following surgery.

Official code: M.3200. Product type: Artificial eye. Official classification: Class 1. An artificial eye is a device resembling the anterior portion of the eye, usually made of glass or plastic, intended to be inserted in a patient's eye socket anterior to anorbital implant, or the eviscerated eyeball, for cosmetic purposes. The device is not intended to be implanted.

Official code: M.3300. Product type: Absorbable implant (scleral buckling method). Official classification: Class 2. An absorbable implant (scleral buckling method) is a device intended to be implanted on the sclera to aid retinal reattachment.

Official code: M.3320. Product type: Eye sphere implant. Official classification: Class 2. An eye sphere implant is a device intended to be implanted in the eyeball to occupy space following the removal of the contents of the eyeball with the sclera left intact.

Official code: M.3340. Product type: Extraocular orbital implant. Official classification: Class 2. An extraocular orbital implant is a nonabsorbable device intended to be implanted during scleral surgery for buckling or building up the floor of the eye, usually in conjunction with retinal reattachment. Injectable substances are excluded.

Official code: M.3400. Product type: Keratoprosthesis. Official classification: Class 2. A keratoprosthesis is a device intended to provide a transparent optical pathway through an opacified cornea, either intraoperatively or permanently, in an eye that is not a reasonable candidate for a corneal transplant.

Official code: M.3600. Product type: Intraocular lens. Official classification: Class 3. An intraocular lens is a device made of materials such as glass or plastic intended to be implanted to replace the natural lens of an eye.

Official code: M.3800. Product type: Scleral shell. Official classification: Class 1. A scleral shell is a device made of glass or plastic that is intended to be inserted for short time periods over the cornea and proximal- cornea sclera for cosmetic or reconstructive purposes. An artificial eye is usually painted on the device. The device is notintended to be implanted.

Official code: M.3920. Product type: Eye valve implant. Official classification: Class 2. Eye valve implant is an implantable one-way pressure sensitive valve intended to reduce intraocular pressure in the anterior chamber of the eye. This device is for patients with glaucoma.

Official code: M.4070. Product type: Powered corneal burr. Official classification: Class 1. A powered corneal burr is an AC-powered or battery-powered device that is a motor and drilling tool intended to remove rust rings from the cornea of the eye.

Official code: M.4100. Product type: Radiofrequency electrosurgical cautery apparatus. Official classification: Class 2. A radiofrequency electrosurgical cautery apparatus is an AC-powered or battery-powered device intended for use during ocular surgery to coagulate tissue or arrest bleeding by a high frequency electric current.

Official code: M.4115. Product type: Thermal cautery unit. Official classification: Class 2. A thermal cautery unit is an AC-powered or battery-powered device intended for use during ocular surgery to coagulate tissue or arrest bleeding by heat conducted through a wire tip.

Official code: M.4150. Product type: Vitreous aspiration and cutting instrument. Official classification: Class 2. A vitreous aspiration and cutting instrument is an electrically powered device, which may use ultrasound, intended to remove vitreous matter from the vitreous cavity or remove a crystalline lens.

Official code: M.4155. Product type: Scleral plug. Official classification: Class 2. A scleral plug is a device intended to provide temporary closure of a scleral incision during an ophthalmic surgical procedure. These plugs prevent intraocular fluid and pressure loss when instruments are withdrawn from the eye. Scleral plugs include a head portion remaining above the sclera, which can be gripped for insertion and removal, and a shaft that fits inside the scleralincision. Scleral plugs are removed before completing the surgery.

Official code: M.4170. Product type: Cryophthalmic unit. Official classification: Class 2. A cryophthalmic unit is a device that is a probe with a small tip that becomes extremely cold through the controlled use of a refrigerant or gas. The device may be AC-powered. The device isintended to remove cataracts by the formation of an adherent ice ball in the lens, to freeze the eye and adjunct parts for surgical removal of scars, and to freeze tumors.

Official code: M.4250. Product type: Ophthalmic electrolysis unit. Official classification: Class 1,2. An ophthalmic electrolysis unit is an AC-powered or battery-powered device intended to destroy ocular hair follicles by applying a galvanic electrical current. Classification: (1) Class 1 battery-powered device. (2) Class 2 AC-powered device.

Official code: M.4270. Product type: Intraocular gas. Official classification: Class 3. An intraocular gas is a device consisting of a gaseous fluid intended to be introduced into the eye to place pressure on a detached retina.

Official code: M.4275. Product type: Intraocular fluid. Official classification: Class 3. An intraocular fluid is a device consisting of a nongaseous fluid intended to be introduced into the eye to aid performance of surgery, such as to maintain anterior chamber depth, preserve tissue integrity, protect tissue from surgical trauma, or function as a tamponade during retinal reattachment.

Official code: M.4280. Product type: Intraocular pressure measuring device. Official classification: Class 3. An intraocular pressure measuring device is a manual or AC-powered device intended to measure intraocular pressure. Also included are any devices found by FDA to be substantially equivalent to such devices. Accessories for the device may include calibrators or recorders. The device is intended for use in the diagnosis of glaucoma.

Official code: M.4300. Product type: Intraocular lens guide. Official classification: Class 1. An intraocular lens guide is a device intended to be inserted into the eye during surgery to direct the insertion of an intraocular lens and be removed after insertion is completed.

Official code: M.4335. Product type: Operating headlamp. Official classification: Class 1,2. An operating headlamp is an AC-powered or battery-powered device intended to be worn on the user's head to provide a light source to aid visualization during surgical, diagnostic, or therapeutic procedures. Classification: (1) Class 1 battery-powered device. (2) Class 2 AC-powered device.

Official code: M.4350. Product type: Manual ophthalmic surgical instrument. Official classification: Class 1. A manual ophthalmic surgical instrument is a nonpowered, handheld device intended to aid or perform ophthalmic surgical procedures.This generic type of device includes the manual corneal burr, ophthalmic caliper, ophthalmic cannula, eyelid clamp, ophthalmic muscle clamp, iris retractor clip, orbital compressor, ophthalmic curette, cystotome, orbital depressor, lachrymal dilator, erisophake, expressor, ophthalmic forcep, ophthalmic hook, sphere introducer, ophthalmic knife, ophthalmic suturing needle, lachrymal probe, trabeculotomy probe, cornea-sclera punch, ophthalmic retractor, ophthalmic ring (Flieringa), lachrymal sac rongeur, ophthalmic scissors, enucleating snare, ophthalmic spatula, ophthalmic specula, ophthalmic spoon, ophthalmic spud, trabeculotome or ophthalmic manual trephine.

Official code: M.4360. Product type: Ocular surgery irrigation device. Official classification: Class 1. An ocular surgery irrigation device is a device intendedto be suspended over the ocular area during ophthalmic surgery to deliver continuous, controlled irrigation to the surgical field.

Official code: M.4370. Product type: Keratome. Official classification: Class 1. A keratome is an AC-powered or battery-powered device intended to shave tissue from sections of the corneafor a lamellar (partial thickness) transplant.

Official code: M.4390. Product type: Ophthalmic laser. Official classification: Class 2. An ophthalmic laser is an AC-powered device intended to coagulate or cut tissue of the eye, orbit, or surrounding skin by a laser beam.

Official code: M.4392. Product type: Nd:YAG laser for posterior capsulotomy. Official classification: Class 2. The Nd:YAG laser for posterior capsulotomy and peripheral iridotomy consists of a mode-locked or Q-switched solid state Nd:YAG laser intended for disruption of the posterior capsule or the iris via optical breakdown. The Nd:YAG laser generates short pulse, low energy, high power, coherent optical radiation. When the laser output is combined with focusing optics, the high irradiance at the target causes tissue disruption via optical breakdown. A visible aiming system is utilized to target the invisible Nd:YAG laser radiation on or in close proximity to the target tissue.

Official code: M.4400. Product type: Electronic metal locator. Official classification: Class 2. An electronic metal locator is an AC-powered device with probes intended to locate metallic foreign bodies in the eye or eye socket.

Official code: M.4570. Product type: Ophthalmic surgical marker. Official classification: Class 1. An ophthalmic surgical marker is a device intended to mark by use of ink, dye, or indentation the location of ocular or scleral surgical manipulation.

Official code: M.4610. Product type: Ocular pressure applicator. Official classification: Class 2. An ocular pressure applicator is a manual device that consists of a sphygmomanometer-type squeeze bulb, a dial indicator, a band, and bellows, intended to apply pressure on the eye in preparation for ophthalmic surgery.

Official code: M.4670. Product type: Phacofragmentation system. Official classification: Class 2. A phacofragmentation system is an AC-powered device with a fragmenting needle intended for use in cataract surgery to disrupt a cataract with ultrasound and extract the cataract.

Official code: M.4690. Product type: Ophthalmic photocoagulator. Official classification: Class 2. An ophthalmic photocoagulator is an AC-powered device intended to use the energy from an extended noncoherent light source to occlude blood vessels of the retina, choroid, or iris.

Official code: M.4750. Product type: Ophthalmic eye shield. Official classification: Class 1. An ophthalmic eye shield is a device that consists of a plastic or aluminum eye coveringintended for protection during eye surgery, injury, diseaseor retain dressing materials in place.

Official code: M.4770. Product type: Ophthalmic operating spectacles (loupes). Official classification: Class 1. Ophthalmic operating spectacles (loupes) are devices that consist of convex lenses or lens systems intended to be worn by a surgeon to magnify the surgical site during ophthalmic surgery.

Official code: M.4790. Product type: Ophthalmic sponge. Official classification: Class 2. An ophthalmic sponge is a device that is an absorbant sponge, pad, or spear made of folded gauze, cotton, cellulose, or other material intended to absorb fluids from the operative field in ophthalmic surgery.

Official code: M.5100. Product type: Ophthalmic beta radiation source. Official classification: Class 2. An ophthalmic beta radiation source is a device intended to apply superficial radiation to benign and malignant ocular growths.

Official code: M.5200. Product type: Eyelid thermal pulsation system. Official classification: Class 2. An eyelid thermal pulsation system is an electrically-powered device intended for use in the application of localized heat and pressure therapy to the eyelids. The device is used in adult patients with chronic cystic conditions of the eyelids, including meibomian gland dysfunction (MGD), also known as evaporative dry eye or lipid deficiency dry eye. The system consists of a component that is inserted around the eyelids and a component to control the application of heat and pressure to the eyelids.

Official code: M.5300. Product type: Tear electrostimulation device. Official classification: Class 2. A tear electrostimulation device is a non-implantable, electrostimulation device intended to increase tear production.

Official code: M.5310. Product type: Intranasal electrostimulation device for dry eye symptoms. Official classification: Class 2. An intranasal electrostimulation device for dry eye symptoms is a non-implantable, electrostimulation device intended to increase tear production for improvement in dry eye symptoms.

Official code: M.5350. Product type: Ultrasound cyclodestructive device. Official classification: Class 2. Ultrasound cyclodestructive device is a device that reduces the intraocular pressure by generating a series of lesions caused by high-intensity focused ultrasound (HIFU) energy in the ciliary body and trabecular meshwork. This device is designed to treat refractory glaucoma.

Official code: M.5600. Product type: Ptosis crutch. Official classification: Class 1. A ptosis crutch is a device intended to be mounted on the spectacles of a patient who has ptosis (drooping of the upper eyelid as a result of faulty development or paralysis) to hold the upper eyelid open.

Official code: M.5700. Product type: Eyelid weight. Official classification: Class 2. An eyelid weight is a device made of gold, tantalum, platinum, iridium,or surgical grade stainless steel that is rectangular in shape and contoured to the shape of the eye. The device is intended for the gravity assisted treatment of lagophthalmos (incomplete eyelid closure)( Lagophthalmos). (1) The external eyelid weight is adhered to the outer skin of the upper eyelid. (2) The implantable eyelid weight is implanted into the upper eyelid.

Official code: M.5844. Product type: Corrective spectacle lens. Official classification: Class 1,2. A corrective spectacle lens is a glass or plastic device that is a lens intended to be worn by a patient in a spectacle frame to provide refractive corrections. The device may be modified to protect the eyes from bright sunlight (i.e., corrective sunglasses). Corrective sunglass lenses may be reflective, tinted, polarizing, or photosensitized. Products made with this corrective spectacle lens include corrective and protective sports goggles, such as swimmers’ goggles, ski goggles, racquetball eye guards, and diving goggles. Classification: (1) Class1 (2) Class 2 devices are intended to have the ability toregulate eyeball growth, thereby delaying the progression of myopia or reducing myopia in children.

Official code: M.5905. Product type: Oral electronic vision aid. Official classification: Class 2. An oral electronic vision aid is a battery-powered device that contains an electrode stimulation array to generate electrotactile stimulation patterns that are derived from digital object images captured by a camera. It is intended to aid profoundly blindpatients in orientation, mobility, and object recognition as an adjunctive device to other assistive methods such as awhite cane or a guide dog.

Official code: M.5916. Product type: Rigid gas permeable contact lens. Official classification: Class 2,3. A rigid gas permeable contact lens is a device intended to be worn directly against the cornea of the eye to correct vision conditions. The device is made of various materials, such as cellulose acetate butyrate, polyacrylate-silicone, or silicone elastomers, whose main polymer molecules generally do not absorb or attract water. Class 2 if the device is intended for daily wear only. Class3 if the device is intended for extended wear.

Official code: M.5918. Product type: Rigid gas permeable contact lens care products. Official classification: Class 1,2. A rigid gas permeable contact lens care product is a device intended for use in the cleaning, conditioning, rinsing, lubricating/rewetting, or storing of a rigid gas permeable contact lens. This includes all solutions and tablets used together with rigid gas permeable contact lenses. Classification: (1) Class 1 contact lens container. ;(2) Class 2 other devices.

Official code: M.5925. Product type: Soft (hydrophilic) contact lens. Official classification: Class 2,3. A soft (hydrophilic) contact lens is a device intended to be worn directly against the cornea and adjacent limbal and scleral areas of the eye to correct vision conditions, act as a therapeutic bandage .The device is made of various polymer materials the main polymer molecules of which absorb or attract a certain volume (percentage) of water.Class 2 if the device is intended for daily wear only. Class 3 if the device is intended for extended wear. The item includes plain soft (hydrophilic) contact lens.

Official code: M.5928. Product type: Soft (hydrophilic) contact lens care products. Official classification: Class 1,2. A soft (hydrophilic) contact lens care product is a device intended for use in the cleaning, rinsing, disinfecting, lubricating/rewetting, or storing of a soft (hydrophilic) contact lens. This includes all solutions and tablets used together with soft (hydrophilic) contact lenses and heat disinfecting units intended to disinfect a soft (hydrophilic) contact lens by means ofheat. Classification: (1) Class 1 contact lens container. ;(2)Class 2 other devices.

Official code: M.9999. Product type: Others(Ophthalmic Devices)1,. Official classification: Class 2,3. The products excluded from the above-classification are adopted in this classification and specified by the central competent health authority.

Official code: N.0001. Product type: Orthopedic extracorporeal shock wave system. Official classification: Class 3. An orthopedic extracorporeal shock wave therapy system is a therapy system for orthopedic diseases.

Official code: N.0003. Product type: Intraarticular hyaluronic acid implants. Official classification: Class 3. Intra-articular hyaluronic acid implants are hyaluronic acid used for intra-articular injections.

Official code: N.0004. Product type: Inflatable bone expander system. Official classification: Class 2. An inflatable boneexpander system is used to expand the vertebral body to form a cavity during vertebroplasty, so as to inject bone cement to restore and stabilize the vertebral body and can also be used for forming pores inside the cancellous bone ofspine, hand, tibia, radius and calcaneus.

Official code: N.0005. Product type: Intervertebral disc. Official classification: Class 3. Intervertebral disc prosthesis is a disc non-fusion implantable device used in intervertebral discreplacement surgery in cervical prosthesisspine and lumbar spine which can retain the height of the intervertebral disc and maintain the activity in the affected segment. Intervertebral disc prosthesis may include but not limited to the following formats: Composite, constructed by multipal components, which is generally formed by two independent end plate and a gasket; Elastic, formed by two end plates and elastic polymer core (the core is elastic which aims tomimic the elasticity of the intervertebral disc); Mechanical, formed by two joint componets with same material in general.

Official code: N.1100. Product type: Arthroscope. Official classification: Class 1,2. Anarthroscope is an electrically powered endoscope intended to make visible the interior of a joint. The arthroscope and accessories also is intended to perform surgery within a joint. Classification: (1) Class 1 for the following manual arthroscopic instruments: cannulas, currettes, drill guides, forceps, gouges, graspers, knives, obturators, osteotomes, probes, punches, rasps, retractors, rongeurs, suture passers, suture knotpushers, suture punches, switching rods, and trocars. (2) Class 2 other devices.

Official code: N.1240. Product type: AC-powered dynamometer. Official classification: Class 2. An AC-powered dynamometer is an AC-powered device intended for medical purposes to assess neuromuscular function or degree of neuromuscular blockage by measuring, with a force transducer (a device that translates force into electrical impulses), the grip- strength of a patient's hand.

Official code: N.1250. Product type: Nonpowered dynamometer. Official classification: Class 1. A nonpowered dynamometer is a mechanical device intended for medical purposes to measure the pinch and grip muscle strength of a patient's hand.

Official code: N.1500. Product type: Goniometer. Official classification: Class 1,2. Identification: A goniometer is an AC-powered or battery powered device intended to evaluate joint function by measuring and recording ranges of motion, acceleration, or forces exerted by a joint. Classification: (1) Class 1 devices that does not useelectrode lead wires and patient cables.;(2) Class 2 devices that uses electrode lead wires and patient cables.

Official code: N.1520. Product type: Nonpowered goniometer. Official classification: Class 1. A nonpowered goniometer is a mechanical device intended for medical purposes to measure the range of motion of joints.

Official code: N.3000. Product type: Bone cap. Official classification: Class 1. A bone cap is a mushroom-shaped device intended to be implanted made of either silicone elastomer or ultra-high molecular weight polyethylene. It is used to cover the severed end of a long bone, such as the humerus or tibia, tocontrol bone overgrowth in juvenile amputees.

Official code: N.3010. Product type: Bone fixation cerclage. Official classification: Class 2. A bone fixation cerclage is a device intended to be implanted that is made of alloys, such as cobalt-chromium-molybdenum, and that consists of a metallic ribbon or flat sheet ora wire. The device is wrapped around the shaft of a long bone, anchored to the bone with wire or screws, and used in the fixation of fractures.

Official code: N.3015. Product type: Bone heterograft. Official classification: Class 3. Bone heterograft is a device intended to be implanted that is made from mature (adult) bovine bones and used to replace human bone following surgery in the cervical region of the spinal column.

Official code: N.3020. Product type: Intramedullary fixation rod. Official classification: Class 2. An intramedullary fixation rod is a device intended to be implanted that consists of a rod made of alloys such as cobalt-chromium- molybdenum and stainless steel. It is inserted into the medullary (bone marrow) canal of long bones for the fixation of fractures.

Official code: N.3023. Product type: In vivo cured intramedullary fixation rod. Official classification: Class 2. An in vivo cured intramedullary fixation rod is a implanted device consisting of a balloon that is inserted into the medullary canal of long bones for the fixation of fractures. The balloon is infused with, and completely encapsulates, a liquid monomer thatis exposed to a curing agent which polymerizes the monomer within the balloon creating a hardened rigid structure.

Official code: N.3025. Product type: Passive tendon prosthesis. Official classification: Class 2. A passive tendon prosthesis is a device intended to be implanted made of silicon elastomer or a polyester reinforced medicalgrade silicone elastomer intended for use in the surgical reconstruction of a flexor tendon of the hand. The device is implanted for a period of 2 to 6 months to aid growth of a new tendon sheath. The device is not intended as a permanent implant nor to function as a replacement for the ligament or tendon nor to function as a scaffold for soft tissue ingrowth.

Official code: N.3027. Product type: Polymethylmethacrylate (PMMA) bone cement. Official classification: Class 2. Polymethylmethacrylate (PMMA) bone cement is a device intended to be implanted that is made from methylmethacrylate, polymethylmethacrylate, esters of methacrylic acid, or copolymers containing polymethylmethacrylate and polystyrene. The device is intended for use in arthroplastic procedures of the hip, knee, and other joints for the fixation of polymer or metallic prosthetic implants to living bone.

Official code: N.3030. Product type: Single/multiple component metallic bone fixation appliance and accessories. Official classification: Class 2. Single/multiple component metallic bone fixation appliances and accessories are devices intended to be implanted consisting of one or more metallic components and their metallic fasteners. The devices contain a plate, a nail/plate combination, or a blade/plate combination that are made of alloys, such as cobalt-chromium-molybdenum, stainless steel, and titanium, that are intended to be held in positionwith fasteners, such as screws and nails, or bolts, nuts, and washers. These devices are used for fixation of fractures of the proximal or distal end of long bones, such as intracapsular, intertrochanteric, intercervical, supracondylar, or condylar fractures of the femur; for fusion of a joint; or for surgical procedures that involve cutting a bone. The devices may be implanted or attached through the skin so that a pulling force (traction) may be applied to the skeletal system.

Official code: N.3040. Product type: Smooth or threaded metallic bone fixation fastener. Official classification: Class 2. A smooth or threaded metallic bone fixation fastener is a device intended to be implanted that consists of a stiff wire segment or rod made of alloys, such as cobalt-chromium-molybdenum and stainless steel, and that may besmooth on the outside, fully or partially threaded, straight or U-shaped; and may be either blunt pointed, sharp pointed, or have a formed, slotted head on the end. It may be used for fixation of bone fractures, for bone reconstructions, as a guide pin for insertion of other implants, or it may be implanted through the skin so that a pulling force (traction) may be applied to the skeletal system.

Official code: N.3045. Product type: Resorbable calcium salt bone void filler device. Official classification: Class 2,3. A resorbable calcium salt bone void filler device is a resorbable implant intended to fill bony voids or gaps of the extremities, spine, and pelvis that are caused by trauma or surgery and are not intrinsic to the stability of the bony structure. Classification: (1) Class 2 devices do not contain medicine. (2) Class 3 devices contain medicine.

Official code: N.3050. Product type: Spinal interlaminal fixation orthosis. Official classification: Class 2. A spinal interlaminal fixation orthosis is a device intended to be implanted made of an alloy, such as stainless steel, thatconsists of various hooks and a posteriorlyplaced compression or distraction rod. The device is implanted, usually across three adjacent vertebrae, to straighten and immobilize the spine to allow bone grafts to unite and fuse the vertebrae together. The device is used primarily in the treatment ofscoliosis (a lateral curvature of the spine), but it also may be used in the treatment of fracture or dislocation of the spine, grades 3 and 4 of spondylolisthesis (a dislocation of the spinal column), and lower back syndrome.

Official code: N.3060. Product type: Spinal intervertebral body fixation orthosis. Official classification: Class 2. A spinal intervertebral body fixation orthosis is a device intended to be implanted made of titanium. It consists of variousvertebral plates that are punched into each of a series of vertebral bodies. An eye-type screw is inserted in a hole in the center of each of the plates. A braided cable is threaded through each eye-type screw. The cable is tightened with a tension device and it is fastened or crimped at each eye-type screw. The device is used to apply force to a series of vertebrae to correct "sway back," scoliosis (lateral curvature of the spine), or other conditions.

Official code: N.3070. Product type: Pedicle screw spinal system. Official classification: Class 2. Pedicle screw spinal systems are multiple component devices, made from a variety of materials, including alloys such as 316L stainless steel, 316LVM stainless steel, 22Cr-13Ni-5Mn stainless steel, Ti-6Al-4V, and unalloyed titanium, that allow the surgeon to build an implant system to fit the patient's anatomical and physiological requirements. Such a spinal implant assemblyconsists of a combination of anchors (e.g., bolts, hooks, and/or screws); interconnection mechanisms incorporating nuts, screws, sleeves, or bolts; longitudinal members (e.g., plates, rods, and/or plate/rod combinations); and/or transverse connectors. Thisdevice is a rigid or semi-regid fixation system andintended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of the thoracic, lumbar, and sacral spine: severe spondylolisthesis of vertebra; degenerative spondylolisthesis with objective evidence of neurologic impairment; fracture; dislocation; scoliosis; kyphosis; spinal tumor; and failed previous fusion pseudarthrosis.

Official code: N.3075. Product type: Posterior cervical screw system. Official classification: Class 2. Posterior cervical screw systems are comprised of multiple, interconnecting components, made from a variety of materials(e.g., stainless steel, pure titanium, titanium alloy, etc.) that allow an implantsystem to be built from the occiput to the upper thoracic spine to fit the patient's anatomical and physiological requirements, as determined by preoperative cross-sectional imaging. Such a spinal assembly consists of a combination of bone anchors via screws (i.e., occipital screws, cervical lateral mass screws, cervical pedicle screws, C2 pars screws, C2 translaminar screws, C2 transarticular screws), longitudinal members (e.g., plates, rods, including dual diameter rods, plate/rod combinations), transverse or cross connectors, interconnection mechanisms (e.g., rod-to- rod connectors, offset connectors), and closure mechanisms (e.g., set screws, nuts). Posterior cervical screw systems are rigidly fixed devices that do not contain dynamic features, including but not limited to: non-uniform longitudinal elements or features that allow more motion or flexibility compared to rigid systems. Posterior cervical screw systems are intended to provide immobilization and stabilization of spinal segments in patients asan adjunct to fusion for acute and chronic instabilities of the cervical spine and/or craniocervical junction and/or cervicothoracic junction such as: traumatic spinal fractures and/or traumatic dislocations, deformities, instabilities, failed previous fusions (e.g., pseudarthrosis), tumors, inflammatory disorders, spinal degeneration, including neck and/or arm pain of discogenic origin as confirmed by imaging studies (radiographs, CT, MRI), degeneration of the facets with instability; and reconstruction following decompression to treat radiculopathy and/or myelopathy.

Official code: N.3080. Product type: Intervertebral body fusion device. Official classification: Class 2,3. An intervertebral body fusion device is an implanted single or multiple component spinal device made from a variety of materials, including titanium and polymers. The device is inserted into the intervertebral body space of the cervical or lumbosacral spine, and is intended for intervertebral body fusion. Classification: (1) Class 2 for intervertebral body fusion devices that contain bone grafting material. (2) Class 3 for intervertebral body fusion devices that include any therapeutic biologic (e.g., bone morphogenic protein)

Official code: N.3100. Product type: Ankle joint metal/composite. Official classification: Class 2. An ankle joint metal/composite semi-constrained cemented prosthesis is a device intended to be implanted to replace an ankle semi-constrained cemented prosthesis joint. The device limits translation and rotation: in one or more planes via the geometry of its articulating surfaces. It has no linkage across-the-joint. This generic type of device includes prostheses that consist of a talar resurfacing component made of alloys, such as cobalt-chromium-molybdenum, and a tibial resurfacing component fabricated from ultra-high molecular weight polyethylene with carbon fibers composite, and is limited to those prostheses intended for use with bone cement.

Official code: N.3110. Product type: Ankle joint metal/polymer semi-constrained cemented prosthesis. Official classification: Class 2. An ankle joint metal/polymer semi-constrained cemented prosthesis is a device intended to be implanted to replace an ankle joint. The device limits translation and rotation in one or more planes via the geometry of its articulating surfaces and has no linkage across-the-joint. This generic type of device includes prostheses that have a talar resurfacing component made of alloys,such as cobalt-chromium-molybdenum, and a tibial resurfacing component made of ultra-high molecular weight polyethylene and is limited to those prostheses intended for use with bone cement.

Official code: N.3120. Product type: Ankle joint metal/polymer non-constrained cemented prosthesis. Official classification: Class 3. An ankle joint metal/polymer non-constrained cemented prosthesis is a device intended to be implanted to replace an ankle joint. The device limits minimally (less than normal anatomic constraints) translation in one or more planes. It has no linkage across- the-joint. This generic type of device includes prostheses that have a tibial component made of alloys, such as cobalt-chromium- molybdenum, and a talar component made of ultra-high molecular weight polyethylene, and is limited to those prostheses intended for use with bone cement.

Official code: N.3150. Product type: Elbow joint metal/metal or metal/polymer constrained cemented prosthesis. Official classification: Class 2. An elbow joint metal/polymer constrained cemented prosthesis is a device intended to be implanted to replace an elbow joint.It is made of alloys, such as cobalt-chromium-molybdenum, or of these alloys and of an ultra-high molecular weight polyethylene bushing. The device prevents dislocation in more than one anatomic plane and consists of two components that are linked together. This generic type of device is limited to those prostheses intended for use with bone cement.

Official code: N.3160. Product type: Elbow joint metal / polymer semi-constrained cemented prosthesis. Official classification: Class 2. An elbow joint metal/polymer semi-constrained cemented prosthesis is a device intended to be implanted to replace an elbow joint. The device limits translation and rotation in one or more planes via the geometry of its articulating surfaces. It has no linkage across-the-joint. This generic type of device includes prostheses that consist of a humeral resurfacing component made of alloys, such as cobalt-chromium-molybdenum, and a radial resurfacing component made of ultra-high molecular weight polyethylene. This generic type of device is limited to those prostheses intended for use with bone cement.

Official code: N.3170. Product type: Elbow joint radial (hemi- elbow) polymer prosthesis. Official classification: Class 2. An elbow joint radial (hemi-elbow) polymer prosthesis is a device intended to be implanted made of medical grade silicone elastomer used to replace the proximal end of the radius.

Official code: N.3180. Product type: Elbow joint humeral (hemi- elbow) metallic uncemented prosthesis. Official classification: Class 3. An elbow joint humeral (hemi-elbow) metallic uncemented prosthesis is a device intended to be implanted made of alloys, such as cobalt-chromium-molybdenum, that is used to replace the distal end of the humerus formed by the trochlea humeri and the capitulum humeri. The generic type of device is limited to prostheses intended for use without bone cement.

Official code: N.3200. Product type: Finger joint metal / metal constrained uncemented prosthesis. Official classification: Class 3. A finger joint metal/metal constrained uncemented prosthesis is a device intended to be implanted to replace a metacarpophalangeal or proximal interphalangeal (finger) joint. The device prevents dislocation in more than one anatomic plane and consists of two components which are linked together. This generic type of device includes prostheses made of alloys, such as cobalt-chromium-molybdenum, or protheses made from alloys and ultra-high molecular weight polyethylene. This generic type of device is limited to prostheses intended for use without bone cement.

Official code: N.3210. Product type: Finger joint metal / metal constrained cemented prosthesis. Official classification: Class 3. A finger joint metal/metal constrained cemented prosthesis is a device intended to be implanted to replace a metacarpophalangeal (finger) joint. This device prevents dislocation in more than one anatomic plane and has components which are linked together. This generic type of device includes prostheses that are made of alloys, such as cobalt-chromium-molybdenum, and is limited to those prostheses intended for use with bone cement.

Official code: N.3220. Product type: Finger joint metal / polymer constrained cemented prosthesis. Official classification: Class 3. A finger joint metal/polymer constrained cemented prosthesis is a device intended to be implanted to replace a metacarpophalangeal or proximal interphalangeal (finger)joint. The device prevents dislocation in more than one anatomic plane, and consists of two components which are linked together. This generic type of device includes prostheses that are made of alloys, such as cobalt-chromium-molybdenum, and ultra-high molecular weight polyethylene, and is limited to those prostheses intended for use with bone cement.

Official code: N.3230. Product type: Finger joint polymer constrained prosthesis. Official classification: Class 2. A finger joint polymer constrained prosthesis is a device intended to be implanted to replace a metacarpophalangeal or proximal interphalangeal (finger) joint. This generic type of device includes prostheses that consist of a single flexible across-the-joint component made from either a silicone elastomer or a combination pf polypropylene and polyester material. The flexible across- the-joint component may be covered with a silicone rubber sleeve.

Official code: N.3300. Product type: Hip joint metal constrained cemented or uncemented prosthesis. Official classification: Class 3. A hip joint metal constrained cemented or uncemented prosthesis is a device intended to beimplanted to replace a hip joint. The device prevents dislocation in more than one anatomic plane and has components that are linked together. This generic type of device includes prostheses that have components made of alloys, such as cobalt-chromium-molybdenum, and is intended for use with or without bone cement.This device is not intended for biological fixation.

Official code: N.3310. Product type: Hip joint metal/polymer constrained cemented or uncemented prosthesis. Official classification: Class 2. A hip joint metal/polymer constrained cemented or uncementedprosthesis is a device intended to be implanted to replace a hip joint. The device prevents dislocation in more than one anatomic plane and has components that are linked together. This generic type of device includes prostheses that have a femoral component made of alloys, such as cobalt-chromium-molybdenum, and an acetabular component made of ultra-high-molecular-weight polyethylene with or without a metal shell, made of alloys, such as cobalt-chromium-molybdenum and titanium alloys. This generic type of device is intended for use with or without bone cement.

Official code: N.3320. Product type: Hip joint metal/metal semi- constrained, with a cemented acetabular component, prosthesis. Official classification: Class 3. A hip joint metal/metal semi-constrained, with a cemented acetabular component, prosthesis is a two-part device intended to be implanted to replace a hip joint. The device limits translation and rotation in one or more planes via the geometry of its articulating surfaces. It has no linkage across-the-joint. This generic type of device includes prostheses that consist of a femoral and an acetabular component, both made of alloys, such as cobalt-chromium-molybdenum. This generic type of device is limited to those prostheses intended for use with bone cement.

Official code: N.3330. Product type: Hip joint metal/metal semi- constrained, with an. Official classification: Class 3. A hip joint metal/metal semi-constrained, with an uncemented acetabular component, prosthesis is a two-part device intended to be implanted to replace a hip joint. The device limits translation and rotation in one or more planes via the geometry of its uncemented acetabular component, prosthesis articulating surfaces. It has no linkage across-the-joint. This generic type of device includes prostheses that consist of a femoral and an acetabular component, both made of alloys, such as cobalt-chromium-molybdenum. The femoral component is intended to be fixed with bone cement. The acetabular component is intended for use without bone cement.

Official code: N.3340. Product type: Hip joint metal/composite semi-constrained cemented prosthesis. Official classification: Class 2. A hip joint metal/composite semi-constrained cemented prosthesis is a two-part device intended to be implanted to replace a hip joint. The device limits translation and rotation in one or more planes via the geometry of its articulating surfaces. It hasno linkage across-the-joint. This generic type of device includes prostheses that consist of a femoral component made of alloys, such as cobalt-chromium-molybdenum, and an acetabular component made of ultra-high molecular weight polyethylene with carbon fibers composite. Both components are intended for use with bone cement.

Official code: N.3350. Product type: Hip joint metal/polymer semi-constrained cemented prosthesis. Official classification: Class 2. A hip joint metal/polymer semi-constrained cemented prosthesis is a device intended to be implanted to replace a hip joint. The device limits translation and rotation in one or more planes via the geometry of its articulating surfaces. It has no linkage across- the-joint. This generic type of device includes prostheses that have a femoral component made of alloys, such as cobalt-chromium- molybdenum, and an acetabular resurfacing component made of ultra-high molecular weight polyethylene and is limited to those prostheses intended for use with bone cement.

Official code: N.3353. Product type: Hip joint metal / ceramic / polymer semi-constrained cemented or nonporous uncemented prosthesis. Official classification: Class 2. A hip joint metal/ceramic/polymer semi-constrained cemented or nonporous uncemented prosthesis is a device intended to be implanted to replace a hip joint. This device limits translation and rotation in one or more planes via the geometry of its articulating surfaces. It has no linkage across-the-joint. The two-part femoral component consists of a femoral stem made of alloys to be fixed in the intramedullary canal of the femur by impaction with or without use of bone cement. The proximal end of the femoral stem is tapered with a surface that ensures positive locking with the spherical ceramic (aluminium oxide, A1203) head of the femoral component. The acetabular component is made of ultra-high molecular weight polyethylene or ultra-high molecular weight polyethylene reinforced with nonporous metal alloys, and used with or without bone cement.

Official code: N.3358. Product type: Hip joint metal / polymer / metal semi-constrained porous-coated uncemented proshesis. Official classification: Class 2. A hip joint metal/polymer/metal semi-constrained porous-coated uncemented prosthesis is a device intended to be implanted to replace a hip joint. The device limits translation and rotation in one or more planes via the geometry of its articulating surfaces. It has no linkage across the joint. This generic type of device has a femoral component made of a cobalt-chromium-molybdenum (Co-Cr-Mo) alloy or a titanium-aluminum-vanadium (Ti-6Al-4V) alloy and an acetabular component composed of an ultra-high molecular weight polyethylene articulating bearing surface fixed in a metal shell made of Co-Cr-Mo or Ti-6Al-4V. The femoral stem and acetabular shell have a porous coating made of, in the case of Co-Cr-Mo substrates, beads of the same alloy, and in the case of Ti-6Al-4V substrates, fibers of commercially pure titanium or Ti-6Al-4Valloy. The porous coating has a volume porosity between 30 and 70 percent, an average pore size between 100 and 1,000 microns, interconnecting porosity, and a porous coating thickness between 500 and 1,500 microns. The generic type of device has a design to achieve biological fixation to bone without the use of bone cement.

Official code: N.3360. Product type: Hip joint femoral(hemi-hip). Official classification: Class 2. A hip joint femoral (hemi-hip) metallic cemented or uncemented prosthesis is a device intended to be implanted to replace a portion metallic cemented or uncemented prosthesis of the hip joint. This generic type of device includes prostheses that have a femoral component made of alloys, such as cobalt- chromium-molybdenum. This generic type of device includes designs which are intended to be fixed to the bone with bone cement as well as designs which have large window-like holes in the stem of the device and which are intended for use without bone cement. However, in these latter designs, fixation of the device is not achieved by means of bone ingrowth.

Official code: N.3370. Product type: Hip joint (hemi-hip) acetabular metal cemented prosthesis. Official classification: Class 3. A hip joint (hemi-hip) acetabular metal cemented prosthesis is a device intended to be implanted to replace a portion of the hip joint. This generic type of device includes prostheses that have an acetabular component made of alloys, such as cobalt-chromium- molybdenum. This generic type of device is limited to those prostheses intended for use with bone cement.

Official code: N.3380. Product type: Hip joint femoral(hemi-hip) trunnion-bearing metal/polyacetal cemented prosthesis. Official classification: Class 3. A hip joint femoral (hemi-hip) trunnion-bearing metal/polyacetal cemented prosthesis is a two-part device intended to be implanted to replace the head and neck of the femur. This generic type of device includes prostheses that consist of a metallic stem made of alloys, such as cobalt-chromium-molybdenum, with an integrated cylindrical trunnion bearing at the upper end of the stem that fits into a recess in the head of the device. The head of the device is made of polyacetal (polyoxymethylene) and it is covered by a metallic alloy, such as cobalt-chromium-molybdenum. The trunnion bearing allows the head of the device to rotate on its stem. The prosthesis is intended for use with bone cement.

Official code: N.3390. Product type: Hip joint femoral(hemi-hip) metal/polymerl cemented or uncementedprosthesis. Official classification: Class 2. A hip joint femoral (hemi-hip) metal/polymer cemented or uncemented prosthesis is a two-part device intended to be implanted to replace the head and neck of the femur. This generic type of device includes prostheses that have a femoral component made of alloys, such as cobalt-chromium-molybdenum, and a snap-fit acetabular component made of an alloy, such as cobalt-chromium- molybdenum, and ultra-high molecular weight polyethylene. This generic type of device may be fixed tothe bone with bone cementor implanted by impaction.

Official code: N.3400. Product type: Hip joint femoral(hemi-hip) metallic resurfacing prosthesis. Official classification: Class 2. A hip joint femoral (hemi-hip) metallic resurfacing prosthesis is a device intended to be implanted to replace a portion of the hip joint. This generic type of device includes prostheses that have a femoral resurfacing component made of alloys, such as cobalt- chromium-molybdenum.

Official code: N.3410. Product type: Hip joint metal/polymer semi-constrained resurfacing cemented prosthesis. Official classification: Class 3. A hip joint metal/polymer or ceramic/polymer semi-constrained resurfacing cemented prosthesis is a two-part device intended to be implanted to replace the articulating surfaces of the hip while preserving the femoral head and neck. The device limits translation and rotation in one or more planes via the geometry of its articulating surfaces. It has no linkage across the joint. This generic type of device includes prostheses that consist of a femoral cap component made of a metal alloy, such as cobalt-chromium- molybdenum, or a ceramic material, that is placed over a surgically prepared femoral head, and an acetabular resurfacing polymer component. Both components are intended for use with bone cement.

Official code: N.3480. Product type: Knee joint femorotibial metallic constrained cemented prosthesis. Official classification: Class 3. A kneejoint femorotibial metallic constrained cemented prosthesis is a device intended to be implanted to replace part of a knee joint. The device prevents dislocation in more than one anatomic plane and has components that are linked together. The onlyknee joint movement allowed by the device is in the sagittal plane. This generic type of device includes prostheses that have an intramedullary stem at both the proximal and distal locations. The upper and lower components may be joined either by a solid bolt orpin, an internally threaded bolt with locking screw, or a bolt retained by circlip. The components of the device are made of alloys, such as cobalt-chromium-molybdenum. The stems of the device may be perforated, but are intended for use with bone cement.

Official code: N.3490. Product type: Knee joint femorotibial metal/composite non- constrained cemented prosthesis. Official classification: Class 2. A knee joint femorotibial metal/composite non-constrained cemented prosthesis is a device intended to be implanted to replace part of a knee joint. The device limits minimally (less than normal anatomic constraints) translation in one or more planes. It has no linkage across-the-joint. This generic type of device includes prostheses that have a femoral condylar resurfacing component or components made of alloys, such as cobalt-chromium-molybdenum, and a tibial condylar component or components made of ultra-high molecular weight polyethylene with carbon fibers composite and are intended for use with bone cement.

Official code: N.3500. Product type: Knee joint femorotibial metal/composite semi- constrained cemented prosthesis. Official classification: Class 2. A knee joint femorotibial metal/composite semi-constrained cemented prosthesis is a two-part device intended to be implanted to replace part of a knee joint. The device limits translation and rotation in one or more planes via thegeometry of its articulating surfaces. It has no linkage across-the-joint. This generic type of device includes prostheses that have a femoral component made of alloys, such as cobalt-chromium-molybdenum, and a tibial component with the articulating surfaces made of ultra-high molecular weight polyethylene with carbon-fibers composite and is limited to those prostheses intended for use with bone cement.

Official code: N.3510. Product type: Knee joint femorotibial metal/polymer constrained cemented prosthesis. Official classification: Class 2. A knee joint femorotibial metal/polymer constrained cemented prosthesis is a device intended to be implanted to replace part of a knee joint. The device limits translation or rotation in one or more planes and has components that are linked together or affined. This generic type of device includes prostheses composed of a ball-and-socket joint located between a stemmed femoral and a stemmed tibial component and a runner and track joint between each pair of femoral and tibial condyles. The ball-and-socket joint is composed of a ball at the head of a column rising from the stemmed tibial component. The ball, the column, the tibial plateau, and the stem for fixation of the tibial component are made of an alloy, such as cobalt-chromium-molybdenum. The ball of the tibial component is held within the socket of the femoral component by the femoral component's flat outer surface. The flat outer surface of the tibial component abuts both a reciprocal flat surface within the cavity of the femoral component and flanges on the femoral componentdesigned to prevent distal displacement. The stem of the femoral component is made of an alloy, such as cobalt-chromium-molybdenum, but the socket of the component is made of ultra-high molecular weight polyethylene. The femoral component has metallic runners which align with the ultra-high molecular weight polyethylene tracks that press-fit into the metallic tibial component. The generic class also includes devices whose upper and lower components are linked with a solid bolt passing through a journal bearing of greater radius, permitting some rotation in the transverse plane, a minimal arc of abduction/adduction. This generic type of device is limited to those prostheses intended for use with bone cement.

Official code: N.3520. Product type: Knee joint femorotibial metal/polymer non- constrained cemented prosthesis. Official classification: Class 2. A knee joint femorotibial metal/polymer non-constrained cemented prosthesis is a device intended to be implanted to replace part of a knee joint. The device limits minimally (less than normal anatomic constraints) translation in one or more planes. It has no linkage across-the-joint. This generic type of device includes prostheses that have a femoral condylar resurfacing component or components made of alloys, such as cobalt-chromium-molybdenum, and a tibial component or components made of ultra-high molecular weight polyethylene and are intended for use with bone cement.

Official code: N.3530. Product type: Knee joint femorotibial metal/polymer semi- constrained cemented prosthesis. Official classification: Class 2. A knee joint femorotibial metal/polymer semi-constrained cemented prosthesis is a device intended to be implanted to replace part of a knee joint. The device limits translation and rotation in one or more planes via the geometry of its articulating surfaces. It has no linkage across-the-joint. This generic type of device includes prostheses that consist of a femoral component made of alloys, such as cobalt-chromium-molybdenum, and a tibial component made of ultra-high molecular weight polyethylene and is limited to those prostheses intended for use with bone cement.

Official code: N.3535. Product type: Knee joint femorotibial unicompartmental mental/polymer porous- coated uncemented prosthesis. Official classification: Class 2. A knee joint femorotibial (uni-compartmental) metal/polymer porous-coated uncemented prosthesis is a device intended to be implanted to replace part of a kneejoint. The device limits translation and rotation in one or more planes via the geometry of its articulating surface. It has no linkage across-the-joint. This generic type of device is designed to achieve biological fixation to bone without the use of bone cement. This identification includes fixed-bearing knee prostheses where the ultra-high molecular weight polyethylene tibial bearing is rigidly secured to the metal tibial baseplate.

Official code: N.3540. Product type: Knee joint patellofemoral polymer/metal semi- constrained cemented prosthesis. Official classification: Class 2. A knee joint patellofemoral polymer/metal semi-constrained cemented prosthesis is a two-part device intended to be implanted to replace part of a knee joint in the treatment of primary patellofemoral arthritis or chondromalacia. The device limits translation and rotation in one or more planes via the geometry of its articulating surfaces. It has no linkage across-the-joint. This generic type of device includes a component made of alloys, such as cobalt-chromium-molybdenum or austenitic steel,for resurfacing the intercondylar groove (femoral sulcus) on the anterior aspect of the distal femur, and a patellar component made of ultra-high molecular weight polyethylene. This generic type of device is limited to those devices intended for use withbone cement.The patellar component is designed to be implanted only with its femoral component.

Official code: N.3550. Product type: Knee joint patellofemorotibial polymer/metal/metal constrained cemented prosthesis. Official classification: Class 3. A knee joint patellofemorotibial polymer/metal/metal constrainedcemented prosthesis is a device intended to be implanted to replace a knee joint. The device prevents dislocation in more than one anatomic plane and has components that are linked together. This generic type of device includes prostheses that have a femoral component, a tibial component, a cylindrical bolt and accompanying locking hardware that are all made of alloys, such as cobalt-chromium-molybdenum, and a retropatellar resurfacing component made of ultra-high molecular weight polyethylene. The retropatellar surfacing component may be attached to the resected patella either with a metallic screw or bone cement. All stemmed metallic components within this generic type are intended for use with bone cement.

Official code: N.3560. Product type: Knee joint patellofemorotibial polymer/metal/polymer semi-constrained cemented prosthesis. Official classification: Class 2. A knee joint patellofemorotibial polymer/metal/polymer semi-constrained cemented prosthesis is a device intended to be implanted to replace a knee joint. The device limits translation and rotation in oneor more planes via the geometry of its articulating surfaces. It has no linkage across-the-joint. This generic type of device includes prostheses that have a femoral component made of alloys, such as cobalt-chromium-molybdenum, and a tibial component or components and a retropatellar resurfacing component made of ultra-high molecular weight polyethylene. This generic type of device is limited to those prostheses intended for use with bone cement.

Official code: N.3565. Product type: Knee joint patellofemorotibial metal/polymer porous- coated uncemented prosthesis. Official classification: Class 2. A knee joint patellofemorotibial metal/polymer porous-coated uncemented prosthesis is a device intended to be implanted to replace a knee joint. The device limits translation and rotation in one or more planes via the geometryof its articulating surfaces. It has no linkage across-the-joint. This generic type of device is designed to achieve biological fixation to bone without the use of bone cement. This identification includes fixed-bearing knee prostheses where the ultra high molecular weight polyethylene tibial bearing is rigidly secured to the metal tibial base plate.

Official code: N.3570. Product type: Knee joint femoral (hemi- knee) metallic uncemented prosthesis. Official classification: Class 3. A knee joint femoral (hemi-knee) metallic uncemented prosthesis is a device made of alloys, such as cobalt-chromium- molybdenum, intended to be implanted to replace part of a knee joint. The device limits translation and rotation in one or more planes via the geometry of its articulating surfaces. It has no linkage across-the-joint. This generic type of device includes prostheses that consist of a femoral component with or without protuberance(s) for the enhancement of fixation and is limitedto those prostheses intended for use without bone cement.

Official code: N.3580. Product type: Knee joint patellar (hemi- knee) metallic resurfacing uncemented prosthesis. Official classification: Class 2,3. A knee joint patellar (hemi-knee) metallic resurfacing uncemented prosthesis is a device made of alloys, such as cobalt-chromium- molybdenum, intended to be implanted to replace the retropatellar articular surface of the patellofemoral joint. The device limits minimally (less than normal anatomic constraints) translation in one or more planes. It has no linkage across-the-joint. This generic type of device includes prostheses that have a retropatellar resurfacingcomponent and an orthopedic screw to transfix the patellar remnant. This generic type of device is limited to those prostheses intended for use without bone cement.Classification: (1) Class 2 when intended for treatment of degenerative and posttraumaticpatellar arthritis. (2) Class 3 when intended for uses other than treatment of degenerative and posttraumatic patellar arthritis.

Official code: N.3590. Product type: Knee joint tibial (hemi- knee) metallic resurfacing uncemented prosthesis. Official classification: Class 2. A knee joint tibial (hemi-knee) metallic resurfacing uncemented prosthesis is a device intended to be implanted to replace part of a knee joint. The device limits minimally (less than normal anatomic constraints) translation in one or more planes. It has no linkage across-the-joint. This prosthesis is made of alloys, such as cobalt-chromium-molybdenum, and is intended to resurface one tibial condyle. The generic type of device is limited to those prostheses intended for use without bone cement.

Official code: N.3640. Product type: Shoulder joint metal/metal or metal/polymer constrained cemented prosthesis. Official classification: Class 3. A shoulder joint metal/metal or metal/polymer constrained cemented prosthesis is a device intended to be implanted to replacea shoulder joint. The device prevents dislocation in more than one anatomic plane and has components that are linked together. This generic type of device includes prostheses that have a humeral component made of alloys, such as cobalt-chromium-molybdenum, and a glenoid component made of this alloy or a combination of this alloy and ultra-high molecular weight polyethylene. This generic type of device is limited to those prostheses intended for use with bone cement.

Official code: N.3650. Product type: Shoulder joint metal / polymer non-constrained cemented prosthesis. Official classification: Class 2. A shoulder joint metal/polymer non-constrained cemented prosthesis is a device intended to be implanted to replace a shoulder joint. The device limits minimally (less than normal anatomic constraints) translation in one or more planes. It has no linkage across-the-joint. This generic type of device includes prostheses that have a humeral component made of alloys, such as cobalt- chromium-molybdenum, and a glenoid resurfacing component made of ultra-high molecular weight polyethylene, and is limited to those prostheses intended for use with bone cement.

Official code: N.3660. Product type: Shoulder joint metal/polymer semi- constrained cemented prosthesis. Official classification: Class 2. A shoulder joint metal/polymer semi-constrained cemented prosthesis is a device intended to be implanted to replace a shoulder joint. The device limits translation and rotation in one or more planes via the geometry of its articulating surfaces. It has no linkage across-the-joint. This generic type of device includes prostheses that have a humeral resurfacing component made of alloys, such as cobalt-chromium-molybdenum, and a glenoid resurfacing component made of ultra-high molecular weight polyethylene, and is limited to those prostheses intended for use with bone cement.

Official code: N.3670. Product type: Shoulder joint metal/polymer/metal nonconstrained or semiconstrained porous- coated uncemented prosthesis. Official classification: Class 2. A shoulder joint metal/polymer/metal nonconstrained or semi-constrained porous-coated uncemented prosthesis is a device intended to be implanted to replace a shoulder joint. The device limits movement in one or more planes. It has no linkage across- the-joint. This generic type of device includes prostheses that have a humeral component made of alloys such as cobalt-chromium- molybdenum (Co-Cr-Mo) and titanium-aluminum-vanadium (Ti-6Al-4V) alloys, and a glenoid resurfacing component made of ultra-high molecular weight polyethylene, or a combination of an articulating ultra-high molecular weight bearing surface fixed in a metal shell made of alloys such as Co-Cr-Mo and Ti-6Al-4V. The humeral component and glenoid backing have a porous coating made of, in the case of Co-Cr-Mo components, beads of the same alloy or commercially pure titanium powder, and in the case of Ti-6Al-4V components, beads or fibers of commercially pure titanium or Ti-6Al-4V alloy, or commercially pure titanium powder. The porous coating has a volumeporosity between 30 and 70 percent, an average pore size between 100 and 1,000 microns, interconnecting porosity, and a porous coating thickness between 500 and 1,500 microns. This generic type of device is designed to achieve biological fixation to bone without the use of bone cement.

Official code: N.3680. Product type: Shoulder joint glenoid (hemi-shoulder)metallic cemented prosthesis. Official classification: Class 3. A shoulder joint glenoid (hemi-shoulder) metallic cemented prosthesis is a device that has a glenoid (socket) component made of alloys, such as cobalt-chromium-molybdenum, or alloys with ultra-high molecular weight polyethylene and intended to be implanted to replace part of a shoulder joint. This generic type of device is limited to those prostheses intended for use with bone cement.

Official code: N.3690. Product type: Shoulder joint humeral (hemi-shoulder)metallic uncemented prosthesis. Official classification: Class 2. A shoulder joint humeral (hemi-shoulder) metallic uncemented prosthesis is a device made of alloys, such as cobalt-chromium- molybdenum. It has an intramedullary stem and is intended to be implanted to replace the articular surface of the proximal end of the humerus and to be fixed without bone cement. This device is not intended for biological fixation.

Official code: N.3720. Product type: Toe joint polymer constrained prosthesis. Official classification: Class 2. A toe joint polymer constrained prosthesisis a device made of silicone elastomer or polyester reinforced silicone elastomer intended to be implanted to replace the first metatarsophalangeal (big toe) joint. This generic type of device consists of asingle flexible across-the-joint component that prevents dislocation in more than one anatomic plane.

Official code: N.3730. Product type: Toe joint phalangeal (hemi- toe)polymer prosthesis. Official classification: Class 2. A toe joint phalangeal (hemi-toe) polymer prosthesis is a device made of silicone elastomer intended to be implanted to replace the base of the proximal phalanx of the toe.

Official code: N.3750. Product type: Wrist joint carpal lunate polymer prosthesis. Official classification: Class 2. A wrist joint carpal lunate prosthesis is a one-piece device made of silicone elastomer intended to be implanted to replace the carpal lunate bone of the wrist.

Official code: N.3760. Product type: Wrist joint carpal scaphoid. Official classification: Class 2. A wrist joint carpal scaphoid polymer prosthesis is a one-piece device made of silicone elastomer intended to be implanted to polymer prosthesisreplace the carpal scaphoid bone of the wrist.

Official code: N.3770. Product type: Wrist joint carpal trapezium polymer prosthesis. Official classification: Class 2. A wrist joint carpal trapezium polymer prosthesis is a one-piece device made of silicone elastomer or silicone elastomer/polyester material intended to be implanted to replace the carpal trapezium bone of the wrist.

Official code: N.3780. Product type: Wrist joint polymer constrained prosthesis. Official classification: Class 2. A wrist joint polymer constrained prosthesis is a device made of polyester-reinforced silicone elastomer intended to be implanted to replace a wrist joint. This generic type of device consists of a single flexible across-the-joint component that prevents dislocation in more than one anatomic plane.

Official code: N.3790. Product type: Wrist joint metal constrained cemented prosthesis. Official classification: Class 3. A wrist joint metal constrained cemented prosthesis is a device intended to be implanted to replace a wrist joint. The device prevents dislocation in more than one anatomic plane and consists of either a single flexible across-the-joint component or two components linked together. This generic type of device is limited to a device which is made of alloys, such as cobalt-chromium- molybdenum, and is limited to those prostheses intended for use with bone cement.

Official code: N.3800. Product type: Wrist joint metal/polymer semi-constrained cemented prosthesis. Official classification: Class 2. A wrist joint metal/polymer semi-constrained cemented prosthesis is a device intended to be implanted to replace a wrist joint. The device limits translation and rotation in one or more planes via the geometry of its articulating surfaces. It has no linkage across-the-joint. This generic type of device includes prostheses that have either a one-part radial component made of alloys, such as cobalt-chromium-molybdenum, with an ultra-high molecular weight polyethylene bearing surface, or a two-part radial component made of alloys and an ultra-high molecular weight polyethylene ball that is mountedon the radial component with a trunnion bearing. The metallic portion of the two-part radial component is inserted into the radius. These devices have a metacarpal component(s) made of alloys, such as cobalt-chromium-molybdenum. This generic type of deviceis limited to those prostheses intended for use with bone cement.

Official code: N.3810. Product type: Wrist joint ulnar(hemi- wrist) polymer prosthesis. Official classification: Class 2. A wrist joint ulnar (hemi-wrist) polymer prosthesis is a mushroom-shaped device made of a medical grade silicone elastomer or ultra-high molecular weight polyethylene intended to be implanted into the intramedullary canal of the bone and held in place by a suture. Its purpose is to cover the resected end of the distal ulna to control bone overgrowth and to provide an articular surface for the radius and carpus.

Official code: N.4150. Product type: Calipers for clinical use. Official classification: Class 1. A caliper for clinical use is a compass-like device intended for use in measuring the thickness or diameter of a part of the body or the distance between two body surfaces, such as for measuring an excised skeletal specimen to determine the proper replacement size of a prosthesis.

Official code: N.4200. Product type: Cement dispenser. Official classification: Class 1. A cement dispenser is a nonpowered syringe-like device intended for use in placing bone cementinto surgical sites.

Official code: N.4210. Product type: Cement mixer for clinical use. Official classification: Class 1. A cement mixer for clinical use is a device consisting of a container intended for use in mixing bone cement

Official code: N.4220. Product type: Cement monomer vapor evacuator. Official classification: Class 1. A cement monomer vapor evacuator is a device intended for use during surgery to contain or remove undesirable fumes, such as monomer vapor from bone cement

Official code: N.4230. Product type: Cement ventilation tube. Official classification: Class 1. A cement ventilation tube is a tube-like device usually made of plastic intended to be inserted into a surgical cavity to allow the release of air or fluid from the cavity as it is being filled with bone cement

Official code: N.4300. Product type: Depth gauge for clinical use. Official classification: Class 1. A depth gauge for clinical use is a measuring device intended for various medical purposes, such as to determine the proper length of screws for fastening the ends of a fractured bone.

Official code: N.4540. Product type: Orthopedic manual surgical instrument. Official classification: Class 1. An orthopedic manual surgical instrument is a nonpowered hand-held device intended for medical purposes to manipulate tissue, or for use with other devices in orthopedic surgery.This generic type of device includes the cerclage applier, awl, bender, drill brace, broach, burr, corkscrew, countersink, pin crimper, wire cutter, prosthesis driver, extractor, file, fork, needle holder, impactor, bending or contouring instrument, compression instrument, passer, socket positioner, probe, femoral neck punch, socket pusher, reamer, rongeur, scissors, screwdriver, bone skid, staple driver, bone screw starter, surgical stripper, tamp, bone tap, trephine, wire twister, and wrench.

Official code: N.4580. Product type: Sonic surgical instrument and accessories/attachments. Official classification: Class 2. A sonic surgical instrument is a hand-held device with various accessories or attachments, such as a cutting tip that vibrates at high frequencies, and is intended for medical purposes to cut bone or other materials, such as acrylic.

Official code: N.4600. Product type: Protractor for clinical use. Official classification: Class 1. A protractor for clinical use is a device intended for use in measuring the angles of bones, such as on x-rays or in surgery.

Official code: N.4800. Product type: Template for clinical use. Official classification: Class 1. A template for clinical use is a device that consists of a pattern or guide intended for medical purposes, such as selecting or positioning orthopedic implants or guiding the marking of tissue before cutting.

Official code: N.5850. Product type: Nonpowered orthopedic traction apparatus and accessories. Official classification: Class 1. A nonpowered orthopedic traction apparatus is a device that consists of a rigid frame with nonpowered traction accessories, such as cords, pulleys, or weights, and that is intended to apply a therapeutic pulling force to the skeletal system.

Official code: N.5890. Product type: Noninvasive traction component. Official classification: Class 1. A noninvasive traction component is a device, such as a head halter, pelvic belt, or a traction splint, that does not penetrate the skin and is intended to assist in connecting a patient to a traction apparatus so that a therapeutic pulling force may be applied to the patient's body.

Official code: N.5940. Product type: Cast component. Official classification: Class 1. A cast component is a device intended for medical purposes to protect or support a cast. This generic type of device includesthe cast heel, toe cap, cast support, and walking iron.

Official code: N.5960. Product type: Cast removal instrument. Official classification: Class 1. A cast removal instrument is an AC-powered, hand-held device intended to remove a cast from a patient. This generic type of device includes the electric cast cutter and cast vacuum.

Official code: N.5980. Product type: Manual castapplication and removal instrument. Official classification: Class 1. A manual cast application and removal instrument is a nonpowered hand-held device intended to be used in applying or removing a cast. This generic type of device includes the cast knife, cast spreader, plaster saw, plaster dispenser, and casting stand.

Official code: N.9999. Product type: Others(Orthopedic Devices)1,. Official classification: Class 2,3. The products excluded from the above-classification are adopted in this classification and specified by the central competent health authority.

Official code: O.0001. Product type: Static electric therapy apparatus. Official classification: Class 2. A static electric therapy apparatus is a device applying electrical field to human body and intended to relieve shoulder stiffness, headache, and chronic constipation. This type of device generally contains voltage transformer circuit, safety circuit, rectification circuit, electrodes, and insulators. The device uses safety circuit to limit its output current and creates a voltage of approximately 600 to 10,000 volts.

Official code: O.0002. Product type: Non-invasive bone growth stimulator. Official classification: Class 3. The non-invasive bone growth stimulator is a non-invasive device used to promote bone growth. This device can use magnetic fields or other working principle to stimulate fracture bones to accelerate healing.

Official code: O.0003. Product type: Topical refrigerant. Official classification: Class 1. Topical refrigerant is the non-medicated spray used to rapid cooling of skin.

Official code: O.0005. Product type: Optical position/movement recording system. Official classification: Class 2. An optical position/movement recording system is a device that monitors the movement of a patient's body. The device assistsa patient for rehabilitation and provides the information to health professionals for evaluating the rehabilitation status of a patient.

Official code: O.0006. Product type: Continuous Passive Motion Device. Official classification: Class 1. Continuous passive motion device is to move a specific joint of the patient through the designed range of motions without applying force. This device aids patients, who suffer joint replacement surgery or with neurological disease, to increase the range of joint motion.

Official code: O.0007. Product type: Wheelchair positioning devices. Official classification: Class 1. A wheelchair positioning device is a device intended for medical purposes that is used witha wheelchair. This device is intended as an aid in supporting and stabilizing patients with abnormal muscle tone to maintain the sitting posture of the wheelchair.This device may include: 1) A wheelchair backrest with a conformal rigid base and a soft cushion. 2) A wheelchair positioning stand with an adjustable mechanical structure that is locked on the wheelchair or the backrest. 3) A wheelchair headrest system with adjustable support height, fore-aft position, and angle. 4)An accessory attached to thewheelchair utilizes a contoured seat surface to provide support for the pelvis, hip joints, inner and outer thighs, thus preventing deformation due to abnormal muscle tension.

Official code: O.1175. Product type: Electrode cable. Official classification: Class 1. An electrode cable is a device composed of strands ofinsulated electrical conductors laid together around a central core and intended for medical purposes to connect an electrode from a patient to a diagnostic machine.

Official code: O.1225. Product type: Chronaximeter. Official classification: Class 2. A chronaximeter is a device intended for medical purposes to measure neuromuscular excitability by means of a strength-duration curve that provides a basis for diagnosis and prognosis of neurological dysfunction.

Official code: O.1375. Product type: Diagnostic electromyograph. Official classification: Class 2. A diagnostic electromyograph is a device intended for medical purposes,such as to monitor and display the bioelectric signals produced by muscles, to stimulate peripheral nerves, and to monitor and display the electrical activity produced by nerves, for the diagnosis and prognosis of neuromuscular disease.

Official code: O.1385. Product type: Diagnostic electromyograph needle electrode. Official classification: Class 2. A diagnostic electromyograph needle electrode is a monopolar or bipolar needle intended to be inserted into muscle or nerve tissue to sense bioelectrical signals. The device is intended for medical purposes for use in connection with electromyography (recording the intrinsic electrical properties of skeletal muscle).

Official code: O.1450. Product type: Powered reflex hammer. Official classification: Class 2. A powered reflex hammer is a motorized device intended for medical purposes to elicit and determine controlled deep tendon reflexes.

Official code: O.1575. Product type: Force-measuring platform. Official classification: Class 1. A force-measuring platform is a device intended for medical purposes that converts pressure applied upon a planar surface into analog mechanical or electrical signals. This device is used to determine ground reaction force, centers of percussion, centers of torque, and their variations in both magnitude and direction with time.

Official code: O.1600. Product type: Intermittent pressure measurement system. Official classification: Class 1. An intermittent pressure measurement system is an evaluative device intended for medicalpurposes, such as to measure the actual pressure between the body surface and the supporting media.

Official code: O.1615. Product type: Miniature pressure transducer. Official classification: Class 1. A miniature pressure transducer is a device intended for medical purposes to measure the pressure between a device and soft tissue by converting mechanical inputs to analog electrical signals.

Official code: O.1850. Product type: Diagnostic muscle stimulator. Official classification: Class 2. A diagnostic muscle stimulator is a device used mainly with an electromyograph machine to initiate muscle activity. It is intended for medical purposes, such as to diagnose motor nerve or sensory neuromuscular disorders and neuromuscular function.

Official code: O.1925. Product type: Isokinetic Testing and Evaluation System. Official classification: Class 1. An isokinetic testing and evaluation system is a rehabilitative exercise device intended for medical purposes, such as to measure, evaluate, and increase the strength of muscles and the range of motion of joints.

Official code: O.3025. Product type: Prosthetic and orthotic accessory. Official classification: Class 1. A prosthetic and orthotic accessory is a device intended for medical purposes to support, protect, or aid in the use of a cast, orthosis (brace), or prosthesis. Examples of prosthetic and orthotic accessories include the following: A pelvic support band and belt, a cast shoe, a cast bandage, a limb cover, a prosthesis alignment device, a postsurgicalpylon, a transverse rotator, and a temporary training splint.

Official code: O.3075. Product type: Cane. Official classification: Class 1. A cane is a device intended for medical purposes that is used to provide minimal weight support while walking. Examples of canes include the following: A standard cane, a forearm cane, and a cane with a tripod, quad, or retractable stud on the ground end.

Official code: O.3100. Product type: Mechanical chair. Official classification: Class 1. A mechanical chair is a manually operated device intended for medical purposes that is used to assist a disabled person in performing an activity thatthe person would otherwise find difficult to do or be unable to do. Examples of mechanical chairs include the following: A chair with an elevating seat used to raise a person from a sitting position to a standing position and a chair with casters used by a person to move from one place to another while sitting.

Official code: O.3110. Product type: Electric positioning chair. Official classification: Class 2. An electric positioning chair is a device with a motorized positioning control that is intended for medical purposes and thatcan be adjusted to various positions. The device is used to provide stability for patients with athetosis (involuntary spasms) and to alter postural positions.

Official code: O.3150. Product type: Crutch. Official classification: Class 1. A crutch is a device intended for medical purposes for use by disabled persons to provide minimal to moderate weight support while walking.

Official code: O.3175. Product type: Flotation cushion. Official classification: Class 1. A flotation cushion is a device intended for medical purposes that is made of plastic, rubber, or other type of covering, that is filled with water, air, gel, mud, or any other substance allowing a flotation media, used on a seat to lessen the likelihood of skin ulcers.

Official code: O.3410. Product type: External limb orthotic component. Official classification: Class 1. An external limb orthotic component is a device intended for medical purposes for use in conjunction with an orthosis (brace)to increase the function of the orthosis for a patient's particular needs. Examples of external limb orthotic components include the following: A brace-setting twister and an external brace stirrup.

Official code: O.3420. Product type: External limb prosthetic. Official classification: Class 1. An external limb prosthetic component is a device intended for medical purposes that, when put together with other appropriate componentcomponents, constitutes a total prosthesis. Examples of external limb prosthetic components include the following: Ankle, foot, hip, knee, and socket components; mechanical or powered hand, hook, wrist unit, elbow joint, and shoulder joint components; and cable and prosthesis suction valves.

Official code: O.3450. Product type: Upper extremity prosthesis. Official classification: Class 2. An upper extremity prosthesis including a simultaneously powered elbow and/or shoulderwith greater than two simultaneous powered degrees of freedom and controlled by non-implanted electrical components, is a device intended for medical purposes, and is intended to replace a partially or fully amputated or congenitally absent upper extremity. It uses electronic inputs (other than simple, manually controlled electrical components such as switches) to provide greater than two independent and simultaneously powered degrees of freedom and includes a simultaneously powered elbow and/or shoulder.Prosthetic arm components that are intended to be used as a system with other arm components must include all degrees of freedom of the total upper extremity prosthesis system.

Official code: O.3475. Product type: Limb orthosis. Official classification: Class 1. A limb orthosis (brace) is a device intended for medical purposes that is worn on the upper or lower extremities to support, to correct, or to prevent deformities or to align body structures for functional improvement. Examples of limb orthoses includethe following: A whole limb and joint brace, a hand splint, an elastic stocking, a knee cage, and a corrective shoe.

Official code: O.3480. Product type: Powered lower extremity exoskeleton. Official classification: Class 2. A powered lower extremity exoskeleton is a device that is composed of an external, powered, motorized orthosis that is placed over a person's paralyzed or weakened limbs for medical purposes.

Official code: O.3490. Product type: Truncal orthosis. Official classification: Class 1. A truncal orthosis is a device intended for medical purposes to support or to immobilize fractures, strains, or sprains of the neck or trunk of the body. Examples of truncal orthoses are the following: Abdominal, cervical, cervical-thoracic, lumbar, lumbo-sacral, rib fracture, sacroiliac, and thoracic orthoses and clavicle splints.

Official code: O.3500. Product type: External assembled lower limb prosthesis. Official classification: Class 1. An external assembled lower limb prosthesis is a device that is intended for medical purposes and is a preassembled external artificial limb for the lower extremity. Examples of external assembled lower limb prostheses are the following: Knee/shank/ankle/foot assembly and thigh/knee/shank/ankle/foot assembly.

Official code: O.3520. Product type: Plinth. Official classification: Class 1. A plinth is a flat, padded board with legs that is intended for medical purposes. A patient is placed on the device for treatment or examination.

Official code: O.3610. Product type: Rigid pneumatic structure orthosis. Official classification: Class 3. A rigid pneumatic structure orthosis is a device intended for medical purposes to provide whole body support by means of a pressurized suit to help thoracic paraplegics walk.

Official code: O.3640. Product type: Arm sling/triangle bandage. Official classification: Class 1. An arm sling/triangle bandageis a device intended for medical purposes to immobilizeor bandageup a part of a patient's body. This device is not elastic. It may include the following areas: head, chest, arms, ankles, hands and knees.

Official code: O.3665. Product type: Congenital hip dislocation abduction splint. Official classification: Class 1. A congenital hip dislocation abduction splint is a device intended for medical purposes to stabilize the hips of a young child with dislocated hips in an abducted position (away from the midline).

Official code: O.3675. Product type: Denis Brown splint. Official classification: Class 1. A Denis Brown splint is a device intended for medical purposes to immobilize the foot. It isused on young children with tibial torsion (excessive rotation of the lower leg) or club foot.

Official code: O.3690. Product type: Powered wheeled stretcher. Official classification: Class 2. A powered wheeled stretcher is a battery-powered table with wheels that is intended for medical purposes for use by patientswho are unable to propel themselves independently and who must maintain a prone or supine position for prolonged periods because of skin ulcers or contractures (muscle contractions).

Official code: O.3750. Product type: Mechanical table. Official classification: Class 1. A mechanical table is a device intended for medical purposes that has a flat surface that can be inclined or adjusted to various positions. It is used by patients with circulatory, neurological, or musculoskeletal conditions to increase tolerance to an upright or standing position.

Official code: O.3760. Product type: Powered table. Official classification: Class 1. A powered table is a device intended for medical purposes that is an electrically operated flat surface table that can be adjusted to various positions. It is used by patients with circulatory, neurological, or musculoskeletal conditions to increasetolerance to an upright or standing position.

Official code: O.3800. Product type: Motorized vehicle for medical purposes. Official classification: Class 2. A motorized vehicle for medical purposes is a gasoline-fueled or battery-powered device intended for medical purposes that is used for transportation by mobilitydisabled persons. The maximum speed limit of motorized vehicles for medical purposes is 10 km/h.

Official code: O.3825. Product type: Mechanical walker. Official classification: Class 1. A mechanical walker is a four-legged device with a metal frame intended for medical purposes to provide moderate weight support while walking. It is used by disabled persons who lack strength, good balance, or endurance.

Official code: O.3850. Product type: Mechanical wheelchair. Official classification: Class 1. A mechanical wheelchair is a manually operated device with wheels that is intended for medical purposes to provide mobility to persons restricted to a sitting position.Mechanical wheelchairs shall comply with the performance requirements of national standard CNS 14964-8, ISO 7176-8 or equivalent international standards.

Official code: O.3860. Product type: Powered wheelchair. Official classification: Class 2. A powered wheelchair is a battery-operated device with wheels that is intended for medical purposes to provide mobility to persons restricted to a sitting position. The maximum speed limit of powered wheelchairs is 10 km/h. This classification contains external power components for use in mechanical wheelchairs

Official code: O.3880. Product type: Special grade wheelchair. Official classification: Class 2. A special grade wheelchair is a device with wheels that is intended for medical purposes to provide mobility to persons restricted to a sitting position. It is intended to be used in all environments for long-term use, e.g., for paraplegics, quadraplegics, and amputees.

Official code: O.3890. Product type: Stair-climbing wheelchair. Official classification: Class 2. A stair-climbing wheelchair is a device with wheels that is intended for medical purposes to provide mobility to persons restricted to a sitting position. The device is intended to climb stairs.

Official code: O.3900. Product type: Standup wheelchair. Official classification: Class 2. A standup wheelchair is a device with wheels that is intended for medical purposes to provide mobility to persons restrictedto a sitting position. The device incorporates an externalmanually controlled mechanical system that is intended to raise a paraplegic to an upright position by means of an elevating seat.

Official code: O.3930. Product type: Mobile wheelchair elevator. Official classification: Class 1,2. A wheelchair elevator is a motorized lift device intended for medical purposes.(a) Providing a means for a disabled person sitting on a wheelchair to move from one level to another. Classification: Class 2. (b) Devices that are operated by an accompany person. Classification: Class 1. The devices are required to meet the electrical safety standard (e.g., IEC 60601-1) and performance standard (e.g., ISO 7176-28 or the other equivalent international standards).

Official code: O.5100. Product type: Immersion hydrobath. Official classification: Class 2. An immersion hydrobath is a device intended for medical purposes that consists of water agitators and that may include a tub to be filled with water. The water temperature may be measured by a gauge. It is used in hydrotherapy to relieve pain and itching and as an aid in the healing process of inflamed and traumatized tissue, and it serves as a setting for removal of contaminated tissue.

Official code: O.5110. Product type: Paraffin bath. Official classification: Class 2. A paraffin bath is a device intended for medical purposes that consists of a tub to be filled with liquid paraffin (wax) andmaintained at an elevated temperature in which the patient's appendages (e.g., hands or fingers) are placed to relieve pain and stiffness.

Official code: O.5125. Product type: Nonpowered sitz bath. Official classification: Class 1. A nonpowered sitz bath is a device intended for medical purposes that consists of a tub to be filled with water for use in external hydrotherapy to relieve painor pruritis and to accelerate the healing of inflamed or traumatized tissues of the perianal and perineal areas.

Official code: O.5150. Product type: Powered patient transport. Official classification: Class 1,2. (a)A powered patient transport is a motorized device intended for medical purposes to assist transfers ofpatients to and from the bath, beds, chairs, treatment modalities, transport vehicles, and up and down flights of stairs. This generic type of devicedoes not include motorized three-wheeled vehicles or wheelchairs. Classification: Class 2. (b) Devices that are operated by an accompany person. Classification: Class 1. The devices are required to meet the electrical safety standard (e.g., IEC 60601-1) and performance standard (e.g., ISO 7176-28 or the other equivalent international standards).

Official code: O.5160. Product type: Air-fluidized bed. Official classification: Class 1. An air-fluidized bed is a device employing the circulation of filtered air through ceramic spherules (small, round ceramic objects) that is intended for medical purposes to treat or prevent bedsores, to treat severe or extensive burns, or to aid circulation.

Official code: O.5170. Product type: Powered flotation therapy bed. Official classification: Class 1. A powered flotation therapy bed is a device that is equipped with a mattress that contains a large volume of constantly moving water, air, mud, or sand. It is intended for medical purposes to treator prevent a patient's bedsores, to treat severe or extensive burns, or to aid circulation. The mattress may be electrically heated.

Official code: O.5180. Product type: Manual patient rotation bed. Official classification: Class 1. A manual patient rotation bed is a device that turns a patient who is restricted to areclining position. It is intended for medical purposes to treat or prevent bedsores, to treat severe and extensive burns, or to aid circulation.

Official code: O.5225. Product type: Powered patient rotation bed. Official classification: Class 1. A powered patient rotation bed is a device that turns a patient who isrestricted to a reclining position. It is intended for medical purposes to treat or prevent bedsores, to treat severe and extensive burns, urinary tract blockage, and to aid circulation.

Official code: O.5250. Product type: Moist steam cabinet. Official classification: Class 2. A moist steam cabinet is a device intended for medical purposes that delivers a flow of heated, moisturized air to a patient in an enclosed unit. It is used to treat arthritis and fibrosis (a formation of fibrosis tissue) and to increase local blood flow.

Official code: O.5275. Product type: Microwave diathermy. Official classification: Class 2,3. (a)Microwave diathermy for use in applying therapeutic deep heat for selected medical conditions --(1)Identification. A microwave diathermy for use in applying therapeutic deep heat for selected medical conditions is a device that applies to specific areas of the body electromagnetic energy in the microwave frequency bands of 915 megahertz to 2,450 megahertz and that is intended to generate deep heat within body tissues for the treatment of selected medical conditions such as relief of pain, muscle spasms, and joint contractures, but not for the treatment of malignancies. (2)Classification: Class 2. (b)Microwave diathermy for all other uses --(1)Identification. A microwave diathermy for all other uses except for the treatment of malignancies is a device that applies tothe body electromagnetic energy in the microwave frequency bands of 915 megahertz to 2,450 megahertz and that is intended for the treatment of medical conditions by means other than the generation of deep heat within body tissues as described in paragraph (a) of this section.(2)Classification: Class 3.

Official code: O.5290. Product type: Shortwave diathermy. Official classification: Class 2,3. (a)Shortwave diathermy for use in applying therapeutic deep heat for selected medical conditions --(1)Identification: A shortwave diathermy for use in applying therapeutic deep heat for selected medical conditions is a device that applies to specific areas of the body electromagnetic energy in the radio frequency bands of 13 megahertz to 27.12 megahertz and that is intended to generate deep heat within body tissues for the treatment of selected medical conditions such as relief of pain, muscle spasms, and joint contractures, but not for the treatment of malignancies. (2)Classification: Class 2. (b)Shortwave diathermy for all other uses --(1)Identification: A shortwave diathermy for allother uses except for the treatment of malignancies is a device that applies to the body electromagnetic energy in the radio frequency bands of 13 megahertz to 27.12 megahertz and that is intended for the treatment of medical conditions by means other than the generation of deep heat within body tissues as described in paragraph (a) of this section. (2) Classification: Class 3.

Official code: O.5300. Product type: Ultrasonic diathermy. Official classification: Class 2,3. (a)Ultrasonic diathermy for use in applying therapeutic deep heat for selected medical conditions --(1)Identification: An ultrasonic diathermy for use in applying therapeutic deep heat for selected medical conditions is a device that applies to specific areas of the body ultrasonic energy at a frequency beyond 20 kilohertz and that is intended to generate deep heat within body tissues for the treatment of selected medical conditions such as relief of pain, muscle spasms, and joint contractures, but not for the treatment of malignancies. (2) Classification: Class 2. (b)Ultrasonic diathermy for all other uses --(1)Identification: An ultrasonic diathermy for all other uses except for the treatment of malignancies is a device that applies to the body ultrasonic energy at a frequency beyond 20 kilohertz and that is intended for the treatment of medical conditionsby means other than the generation of deep heat within body tissues as described in paragraph (a) of this section. (2) Classification: Class 3.

Official code: O.5360. Product type: Measuring exercise equipment. Official classification: Class 2. Measuring exercise equipment consist of manual devices intended for medical purposes, such as to redevelop muscles or restore motion to joints or for use as an adjunct treatment for obesity. These devices also include instrumentation, such as electrocardiograph, spirometer and sphygmomanometer, that provide information used for physical evaluation.

Official code: O.5500. Product type: Infrared lamp. Official classification: Class 2. An infrared lamp is a device intended for medical purposes that emits energy at infrared frequencies (approximately 700 nanometers to 50,000 nanometers) to provide topical heating.

Official code: O.5525. Product type: Iontophoresis device. Official classification: Class 2. (a)Iontophoresis device intended for certain specified uses -Identification: An iontophoresis device is intended for use in the diagnosis of cystic fibrosis or is used along with certain drugs to achieve specific functions. This device uses a current to introduce ions of soluble salts or certain drugs into the patient's body for inducing sweating. This device collects patient's sweat and determines its composition and weight to diagnose cystic fibrosis. Classification: Class 2. (b)Iontophoresis device intended for any other purposes -Identification: An iontophoresis device intended for certain specified uses other than those referred to in paragraph (a) above. This device uses a current to introduce ions of drugs or non-drug solutions into the patient's body for achieving specific medical purposes. Classification: Class 2.

Official code: O.5575. Product type: Powered external limb overload warning device. Official classification: Class 2. A powered external limb overload warning device is a device intended for medical purposes to warn a patient of an overload oran underload in the amount of pressure placed on a leg.

Official code: O.5650. Product type: Powered inflatable tube massager. Official classification: Class 2. A powered inflatable tube massager is a powered device intended for medical purposes, such as to relieve minor muscle aches and pains and to increase circulation. It simulates kneading and stroking of tissues with the hands by use of an inflatable pressure cuff.

Official code: O.5700. Product type: Cold/ Hot pack. Official classification: Class 1. A cold/hotpack is a device intended for medical purposes that consists of a compact fabric envelope containing a specially hydrated pliable silicate gel or a flexible bandage consists of non-medical liquid capable of forming to the contour of the body and that provides cold/hot therapy for body surfaces.

Official code: O.5710. Product type: Hot or cold disposable pack. Official classification: Class 1. A hot or cold disposable pack is a device intended for medical purposes that consists of a sealed plastic bag incorporating chemicals that, upon activation, provides hot or cold therapy for body surfaces.

Official code: O.5720. Product type: Water circulating hot or cold pack. Official classification: Class 1. A water circulating hot or cold pack is a device intended for medical purposes that operates by pumping heated or chilled water through a plastic bag and that provides hot or cold therapy for body surfaces.

Official code: O.5730. Product type: Moist heat pack. Official classification: Class 1. A moist heat pack is a device intended for medical purposes that consistsof silica gel in a fabric container used to retain an elevated temperature and that provides moist heat therapy for body surfaces.

Official code: O.5740. Product type: Powered heating pad. Official classification: Class 1. A powered heating pad is an electrical device intended for medical purposes that provides dry heat therapy for body surfaces. It is capable of maintaining an elevated temperature during use.

Official code: O.5765. Product type: Pressure-applying device. Official classification: Class 1. A presssure-applying device is a device intended for medical purposes to apply continuous pressure to the paravertebral tissues for muscular relaxation and neuro-inhibition. It consists of a table with an adjustable overhead weight that, in place of the therapist's hands, presses on the back of a prone patient.

Official code: O.5850. Product type: Powered muscle stimulator. Official classification: Class 2. A powered muscle stimulator is an electrically powered device intended for medical purposes that repeatedly contracts muscles by passing electrical currents through electrodes contacting the affected body area.

Official code: O.5860. Product type: Ultrasound and muscle stimulator. Official classification: Class 2,3. (a)Ultrasound and muscle stimulator for use in applying therapeutic deep heat for selected medical conditions --(1)Identification. An ultrasound and muscle stimulator for use in applying therapeutic deep heat for selected medical conditions is a device that applies to specific areas of thebody ultrasonic energy at a frequency beyond 20 kilohertz and that is intended to generate deep heat within body tissues for the treatment of selected medical conditions such as relief of pain, muscle spasms, and joint contractures, but not for the treatment of malignancies. The device also passes electrical currents through the body area to stimulate or relax muscles. (2) Classification: Class 2. (b)Ultrasound and muscle stimulator for all other uses - (1) Identification. An ultrasound and muscle stimulatorfor all other uses except for the treatment of malignancies is a device that applies to the body ultrasonic energy at a frequency beyond 20 kilohertz and applies to the body electrical currents and that is intended for the treatment of medical conditions by means other than the generation of deep heat within body tissues and the stimulation or relaxation of muscles as described in paragraph (a) of this section. (2) Classification: Class 3.

Official code: O.5880. Product type: Multi-function physical therapy table. Official classification: Class 2. A multi-function physical therapy table is a device intended for medical purposes that consists of a motorized table equipped to provide patients with heat, traction, and muscle relaxation therapy.

Official code: O.5900. Product type: Powered traction equipment. Official classification: Class 2. Powered traction equipment consists of powered devices intended for medical purposes for use in conjunction with traction accessories, such as belts and harnesses, to exert therapeutic pulling forces on the patient's body.

Official code: O.5925. Product type: Traction accessory. Official classification: Class 1. A traction accessory is a nonpowered accessory device intended for medical purposes to be used with powered traction equipment to aid in exerting therapeutic pulling forces on the patient's body. This generic type of device includes the pulley, strap,head halter, and pelvic belt.

Official code: O.9999. Product type: Others(Physical Medicine Devices) 1,. Official classification: Class 2,3. The products excluded from the above-classification are adopted in this classification and specified by the central competent health authority.

Official code: P.0002. Product type: Blood irradiator to prevent graft versus host disease. Official classification: Class 2. An ionizing radiation blood irradiator is a device that generates ionizing radiation to irradiate blood and blood products (blood packs), making the lymphoid cells in the blood deactivate for the prevention of graft versus host disease (GVHD).

Official code: P.1000. Product type: Magnetic resonance diagnostic device. Official classification: Class 2. A magnetic resonance diagnostic device is intended for general diagnostic use to present images which reflect the spatial distribution and/or magnetic resonance spectra which reflect frequency and distribution of nuclei exhibiting nuclear magnetic resonance. Other physical parameters derived from the images and/or spectra may also be produced. The device includes hydrogen- 1 (proton) imaging, sodium-23 imaging, hydrogen-1 spectroscopy, phosphorus-31 spectroscopy, and chemical shift imaging (preserving simultaneous frequency and spatial information).

Official code: P.1100. Product type: Scintillation (gamma) camera. Official classification: Class 1. A scintillation (gamma) camera is a device intended to image the distribution of radionuclides in the body by means of a photon radiation detector. This generic type of device may include signal analysis and display equipment, patient and equipment supports, radionuclide anatomical markers, component parts, and accessories.

Official code: P.1110. Product type: Positron camera. Official classification: Class 1. A positron camera is a device intended to image the distribution of positron-emitting radionuclides in the body. This generic type of device may include signal analysis and display equipment, patient and equipment supports, radionuclide anatomical markers, component parts, and accessories.

Official code: P.1130. Product type: Nuclear whole body counter. Official classification: Class 1. A nuclear whole body counter is a device intended to measure the amount of radionuclides in the entire body. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.

Official code: P.1170. Product type: Bone densitometer. Official classification: Class 2. A bone densitometer is a device intended for medical purposes to measure bone density and mineral content by x-ray or gamma ray transmission measurements through the bone and adjacent tissues. This generic type of devicemay include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.

Official code: P.1180. Product type: Bone Sonometer. Official classification: Class 2. A bone sonometer is a device that transmits ultrasound energy into the human body to measure acoustic propertiesof bone that indicate overall bone health and fracture risk. The primary components of the device are a voltage generator, a transmitting transducer, a receiving transducer, and hardware and software for reception and processing of the received ultrasonic signal.

Official code: P.1200. Product type: Emission computed tomography system. Official classification: Class 2. An emission computed tomography system is a device intended to detect the location and distribution of gamma ray- and positron- emitting radionuclides in the body and produce cross-sectional images through computer reconstruction of the data. This generic type of device may include signal analysis and display equipment, patient and equipment supports, radionuclide anatomical markers, component parts, and accessories.

Official code: P.1220. Product type: Fluorescent scanner. Official classification: Class 2. A fluorescent scanner is a device intended to measure the induced fluorescent radiation in the body by exposing the body to certain x-rays or low-energy gamma rays. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts and accessories.

Official code: P.1300. Product type: Nuclear rectilinear scanner. Official classification: Class 1. A nuclear rectilinear scanner is a device intended to image the distribution of radionuclides in the body by means of a detector (or detectors) whose position moves in two directions with respect to the patient. This generic type of device may include signal analysis and display equipment, patient and equipment supports, radionuclide anatomical markers, component parts, and accessories.

Official code: P.1310. Product type: Nuclear tomography system. Official classification: Class 2. A nuclear tomography system is a device intended to detect nuclear radiation in the body and produce images of a specific cross- sectional plane of the body by blurring or eliminating detail from other planes. This generic type of devices may include signal analysis and display equipment, patient and equipment supports, radionuclide anatomical markers, component parts, and accessories.

Official code: P.1320. Product type: Nuclear uptake probe. Official classification: Class 1. A nuclear uptake probe is a device intended to measure the amount of radionuclide taken up by aparticular organ or body region. This generic type of device may include a single or multiple detector probe, signal analysis and display equipment, patient and equipment supports, component parts, and accessories.

Official code: P.1330. Product type: Nuclear whole body scanner. Official classification: Class 1. A nuclear whole body scanner is a device intended to measure and image the distribution of radionuclides in the body by means of a wide-aperture detector whose position moves in one direction with respect to the patient. This generic type of device may includesignal analysis and display equipment, patient and equipment supports, radionuclide anatomical markers, component parts, and accessories.

Official code: P.1350. Product type: Nuclear scanning bed. Official classification: Class 1. A nuclear scanning bed is an adjustable bed intended to support a patient during a nuclear medicine procedure.

Official code: P.1360. Product type: Radionuclide dose calibrator. Official classification: Class 2. A radionuclide dose calibrator is a radiation detection device intended to assay radionuclides before their administration to patients.

Official code: P.1390. Product type: Radionuclide rebreathing system. Official classification: Class 2. A radionuclide rebreathing system is a device intended to be used to contain a gaseous or volatile radionuclide or a radionuclide- labeled aerosol and permit it to be respired by the patient during nuclear medicine ventilatory tests (testing process of exchange between the lungs and the atmosphere). This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.

Official code: P.1400. Product type: Nuclear sealed calibration. Official classification: Class 1. A nuclear sealed calibration source is a device that consists of an encapsulated reference radionuclide intended for calibration of sourcemedical nuclear radiation detectors.

Official code: P.1410. Product type: Nuclear electrocardiograph synchronizer. Official classification: Class 1. A nuclear electrocardiograph synchronizer is a device intended for use innuclear radiology to relate the time of image formation to the cardiac cycle during the production of dynamic cardiac images.

Official code: P.1540. Product type: Nonfetal ultrasonic monitor. Official classification: Class 2. A nonfetal ultrasonic monitor is a device that projects a continuous high-frequency sound wave into body tissue other than a fetus to determine frequency changes (doppler shift) in the reflected wave and is intended for use in the investigation of nonfetalblood flow and other nonfetal body tissues in motion. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.

Official code: P.1550. Product type: Ultrasonic pulsed doppler imaging system. Official classification: Class 2. An ultrasonic pulsed doppler imaging system is a device that combines the features of continuous wave doppler-effect technology with pulsed-echo effect technology and is intended to determine stationary body tissue characteristics, such as depth or location of tissue interfaces or dynamic tissue characteristics such as velocity of blood or tissue motion. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.

Official code: P.1560. Product type: Ultrasonic pulsed echo imaging system. Official classification: Class 2. An ultrasonic pulsed echo imaging system is a device intended to project a pulsed sound beam into body tissue to determine the depth or location of the tissue interfaces and to measure the duration of an acoustic pulse from the transmitter to the tissue interface and back to the receiver. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.

Official code: P.1570. Product type: Diagnostic ultrasonic transducer. Official classification: Class 2. A diagnostic ultrasonic transducer is a device made of a piezoelectric material that convertselectrical signals into acoustic signals and acoustic signals into electrical signals and intended for use in diagnostic ultrasonic medical devices. Accessories of this generic type of device may include transmission media for acoustically coupling the transducer to the body surface, such as acoustic gel, paste, or a flexible fluid container.

Official code: P.1600. Product type: Angiographic x-ray system. Official classification: Class 2. An angiographic x-ray system is a device intended for radiologic visualization of the heart, blood vessels, or lymphatic system during or after injection of a contrast medium. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.

Official code: P.1610. Product type: Diagnostic x-ray beam- limiting device. Official classification: Class 2. A diagnostic x-ray beam-limiting device is a device such as a collimator, a cone, or an aperture intended to restrict the dimensions of a diagnostic x-ray field by limiting the size of the primary x-ray beam.

Official code: P.1620. Product type: Cine or spot fluorographic x-ray camera. Official classification: Class 2. A cine or spot fluorographic x-ray camera is a device intended to photograph diagnostic images produced by x-rays with an image intensifier.

Official code: P.1630. Product type: Electrostatic x-ray imaging system. Official classification: Class 2. An electrostatic x-ray imaging system is a device intended for medical purposes thatuses an electrostatic field across a semiconductive plate, a gas-filled chamber, or other similar device to convert a pattern of x-radiation into an electrostatic image and, subsequently, into a visible image. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.

Official code: P.1640. Product type: Radiographic film marking. Official classification: Class 1. A radiographic film marking system is a device intended for medical purposes to add identification and other information onto systemradiographic film by means of exposure to visible light.

Official code: P.1650. Product type: Image-intensified fluoroscopic x-ray system. Official classification: Class 2. An image-intensified fluoroscopic x-ray system is a device intended to visualize anatomical structures by converting a pattern of x-radiation into a visible image through electronic amplification. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.

Official code: P.1660. Product type: Non-image-intensified fluoroscopic x-ray system. Official classification: Class 2. A non-image-intensified fluoroscopic x-ray system is a device intended to be used to visualize anatomical structures by using a fluorescent screen to convert a pattern of x-radiation into a visible image. This generic type of device may includesignal analysis and display equipment, patient and equipment supports, component parts, and accessories.

Official code: P.1670. Product type: Spot-film device. Official classification: Class 2. A spot-film device is an electromechanical component of a fluoroscopic x-ray system that is intended to be used for medical purposes to position a radiographic film cassette to obtain radiographs during fluoroscopy.

Official code: P.1680. Product type: Stationary x-ray system. Official classification: Class 2. A stationary x-ray system is a permanently installed diagnostic system intended to generate and control x-rays for examination of various anatomical regions. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.

Official code: P.1700. Product type: Diagnostic x-ray high voltage generator. Official classification: Class 1. A diagnostic x-ray high voltagegenerator is a device that is intended to supply and control the electrical energy applied to a diagnostic x-ray tube for medical purposes. This generic type of device may include a converter that changes alternating current to direct current, filament transformers for the x-ray tube, high voltage switches, electrical protective devices, or other appropriate elements.

Official code: P.1710. Product type: Mammographic x-ray system. Official classification: Class 2. A mammographic x-ray system is a device intended to be used to produce radiographs of the breast. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.

Official code: P.1715. Product type: Full-field digital mammography system. Official classification: Class 2. A full-field digital mammography system(FFDM) is a device intended to produce planar digital x-ray images of the entire breast. This generic type of device may include digital mammography acquisition software, full-field digital image receptor, acquisition workstation, automatic exposure control, image processing and reconstruction programs, patient and equipment supports, component parts, and accessories.

Official code: P.1720. Product type: Mobile x-ray system. Official classification: Class 2. A mobile x-ray system is a transportable device system intended to be used to generate and control x-ray for diagnostic procedures. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.

Official code: P.1730. Product type: Photofluorographic x-ray system. Official classification: Class 2. A photofluorographic x-ray system is a device that includes a fluoroscopic x-ray unit and a camera intended to be used to produce, then photograph, a fluoroscopic image of the body. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.

Official code: P.1740. Product type: Tomographic x-ray system. Official classification: Class 2. A tomographic x-ray system is an x-ray device intended to be used to produce radiologic images of a specific cross-sectional plane of the body by blurring or eliminating detail from other planes. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.

Official code: P.1750. Product type: Computed tomography x- ray system. Official classification: Class 2. A computed tomography x-ray system is a diagnostic x-ray system intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data from the same axial plane taken at different angles. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.

Official code: P.1760. Product type: Diagnostic x-ray tube housing assembly. Official classification: Class 1. A diagnostic x-ray tube housing assembly is an x-ray generating tube encased in a radiation-shielded housing that is intended for diagnostic purposes. This generic type of device may include high voltage and filament transformers or other appropriate components.

Official code: P.1820. Product type: Pneumoencephalographic chair. Official classification: Class 2. A pneumoencephalographic chair is a chair intended to support and position a patient during pneumoencephalography (x-ray imaging of the brain).

Official code: P.1830. Product type: Radiologic patient cradle. Official classification: Class 1. A radiologic patient cradle is a support device intended to be used for rotational positioning about the longitudinal axis ofa patient during radiologic procedures.

Official code: P.1840. Product type: Radiographic film. Official classification: Class 1. Radiographic film is a devicethat consists of a thin sheet of radiotransparent material coated on one or both sides with a photographic emulsion intended to record images during diagnostic radiologic procedures.

Official code: P.1850. Product type: Radiographic film cassette. Official classification: Class 2. A radiographic film cassette is a device intended for use during diagnostic x-ray procedures to hold a radiographic film in close contact with an x-ray intensifying screen and to provide a light-proof enclosure for direct exposure of radiographic film.

Official code: P.1860. Product type: Radiographic film/cassette changer. Official classification: Class 2. A radiographic film/cassette changer is a device intended to be used during a radiologic procedure to move a radiographic film or cassette between x-ray exposures and to position it during the exposure.

Official code: P.1870. Product type: Radiographic film/cassette changer programmer. Official classification: Class 2. A radiographic film/cassette changer programmer is a device intended to be used to control the operations of a film or cassette changer during serial medical radiography.

Official code: P.1900. Product type: Automatic radiographic film processor. Official classification: Class 2. An automatic radiographic film processor is a device intended to be used to develop, fix, wash, and dry automatically and continuously film exposed for medical purposes.

Official code: P.1910. Product type: Radiographic grid. Official classification: Class 1. A radiographic grid is a device that consists of alternating radiolucent and radiopaque strips intended to be placed between the patient and the image receptor to reduce the amount of scattered radiation reaching the image receptor.

Official code: P.1920. Product type: Radiographic head holder. Official classification: Class 1. A radiographic head holder is a device intended to position the patient's head during a radiographic procedure.

Official code: P.1960. Product type: Radiographic intensifying screen. Official classification: Class 1. A radiographic intensifying screen is a device that is a thin radiolucent sheet coated with a luminescent material that transforms incident x-ray photons into visible light and intended for medical purposes to expose radiographic film.

Official code: P.1970. Product type: Radiographic ECG/respirator synchronizer. Official classification: Class 1. A radiographic ECG/respirator synchronizer is a device intended to be used tocoordinatean x-ray film exposure with the signal from an electrocardiograph (ECG) or respirator at a predetermined phase of the cardiac or respiratory cycle.

Official code: P.1980. Product type: Radiographic table. Official classification: Class 1. A radiologic table is a device intended for medical purposes to support a patient during radiologic procedures. The table maybe fixed or tilting and may be electrically powered.

Official code: P.1990. Product type: Transilluminator for breast. Official classification: Class 3. A transilluminator, also known as a diaphanoscope or lightscanner, is an electrically powered device that uses low intensity evaluationemissions of visible light and near-infrared radiation (approximately 700-1050 nanometers (nm)), transmitted through the breast, to visualize translucent tissue for the diagnosis of cancer, other conditions, diseases, or abnormalities.

Official code: P.2010. Product type: Medical image storage device. Official classification: Class 1. A medical image storage device is a device that provides electronic storage and retrieval functions for medical images. Examples include devices employing magnetic and optical discs, magnetic tape, and digital memory.

Official code: P.2020. Product type: Medical image communication device. Official classification: Class 1. A medical image communications device provides electronic transfer of medical image data between medical devices. It may include a physical communications medium, modems, and interfaces.It may provide simple image review software functionality for medical image processing and manipulation, such as grayscale window and level, zoom and pan, user delineated geometric measurements, compression, or user added image annotations. The device does not perform advanced image processing or complex quantitative functions.

Official code: P.2030. Product type: Medical image digitizer. Official classification: Class 2. A medical image digitizer is a device intended to convert an analog medical image into a digital format. Examples include Iystems employing video frame grabbers, and scanners which use lasers or charge-coupled devices.

Official code: P.2040. Product type: Medical image hardcopy device. Official classification: Class 2. A medical image hardcopy device is a device that produces a visible printed record of a medical image and associated identification information. Examples include multiformat cameras and laser printers.

Official code: P.2050. Product type: Medical image management and processingsystem. Official classification: Class 2. A medical image management and processing system is a device that provides one or more capabilities relating to the review and digital processing of medical images for the purposes of interpretation by a trained practitioner of disease detection, diagnosis, or patient management. The software components may provide advanced or complex image processing functions for image manipulation, enhancement, or quantification that are intended for use in the interpretation and analysis of medical images. Advanced image manipulation functions may include image segmentation, multimodality image registration, or 3D visualization. Complex quantitative functions may include semi-automated measurements or time-series measurements.

Official code: P.2060. Product type: Radiological Computer- assisted diagnostic software for lesions suspicious of cancer. Official classification: Class 2. A radiological computer-assisted diagnostic software for lesions suspicious of cancer is an image processing device intended to aid in the characterization of lesions as suspicious for cancer identified on acquired medical images such as magnetic resonance, mammography, radiography, or computed tomography. The device characterizes lesions based on features or information extracted from the images and provides information about the lesion(s) to the user. Diagnostic and patient management decisions are made by the clinical user.

Official code: P.2070. Product type: Radiological Medical image analyzer. Official classification: Class 2. Medical image analyzers, including computer-assisted/aided detection (CADe) devices for mammography breast cancer, ultrasound breast lesions, and radiograph lung nodules detection, is a device that is intended to identify, mark, highlight,or in any other manner direct the clinicians' attention to portions of a radiology image that may reveal abnormalities during interpretation of patient radiology images by the clinicians. This device incorporates pattern recognition and data analysis capabilities and operates on previously acquired medical images. This device is not intended to replace the review by a qualified radiologist, and is not intended to be used for triage, or to recommend diagnosis.

Official code: P.2080. Product type: Radiological computer. Official classification: Class 2. Radiological computer aided triage and notification software is an image processing device intended to aid in prioritization and aided triage and notification software triage of radiological medical images. The device notifies a designated list of clinicians of the availability of time sensitive radiological medical images for review based on computer aided image analysis of those images performed by the device. The device does not mark, highlight, or direct users' attention to a specific location in the original image. The device does notremove cases from a reading queue. The device operates in parallel with the standard of care, which remains the default option for all cases.

Official code: P.5050. Product type: Medical charged-particle radiation therapy system. Official classification: Class 2. A medical charged-particle radiation therapy system is a device that produces by acceleration high energy charged particles (e.g., electrons and protons) intended for use in radiation therapy. This generic type of device may include signal analysis and display equipment, patient and equipment supports, treatment planning computer programs, component parts, and accessories.

Official code: P.5300. Product type: Medical neutron radiation therapy system. Official classification: Class 2. A medical neutron radiation therapy system is a device intended to generate high-energy neutrons for radiation therapy. This generic type of device may include signal analysis and display equipment, patient and equipment support, treatment planning computer programs, component parts, and accessories.

Official code: P.5650. Product type: Manual radionuclide applicator system. Official classification: Class 1. A manual radionuclide applicator system is a manually operated device intended to apply a radionuclide source into the body or to the surface of thebody for radiation therapy. This generic type of device may include patient and equipment supports, component parts, treatment planning computer programs, and accessories.

Official code: P.5700. Product type: Remote controlled radionuclide applicator system. Official classification: Class 2. A remote controlled radionuclide applicator system is an electromechanical or pneumatic device intended to enable an operator to apply, by remote control, a radionuclide source into the body or to the surface of the body for radiation therapy. This generic type of device may include patient and equipment supports, component parts, treatment planning computer programs, and accessories.

Official code: P.5710. Product type: Radiation therapy beam- shaping block. Official classification: Class 2. A radiation therapy beam-shaping block is a device made of a highly attenuating material (such as lead) intended for medical purposes to modify the shape of a beam from a radiation therapy source.

Official code: P.5720. Product type: Rectal balloon for prostate immobilization. Official classification: Class 2. A rectal balloon for prostate immobilization is a single use, inflatable, non-powered positioning device placed in the rectum to immobilize the prostate in patients undergoing radiation therapy. The device is intended to be used during all the phases ofradiation therapy, including treatment planning, image verification, and radiotherapy delivery.

Official code: P.5725. Product type: Absorbable perirectal spacer. Official classification: Class 2. An absorbable perirectal spacer is composed of biodegradable material that temporarily positions the anterior rectal wall away from the prostate during radiotherapy for prostate cancer with the intent to reduce the radiation dosedelivered to the anterior rectum. The absorbable spacer maintains space for the entire course of prostate radiotherapy treatment and is completely absorbed by the patient's body over time.

Official code: P.5730. Product type: Radionuclide brachytherapy source. Official classification: Class 2. A radionuclide brachytherapy source is a device that consists of a radionuclide which may be enclosed in a sealed container made of gold, titanium, stainless steel, or platinum and intended for medical purposes to be placed onto a body surface or into abody cavity or tissue as a source of nuclear radiation for therapy.

Official code: P.5740. Product type: Radionuclide teletherapy source. Official classification: Class 1. A radionuclide teletherapy source is a device consisting of a radionuclide enclosed in a sealed container. The device is intended for radiation therapy, with the radiation source located at a distance from the patient's body.

Official code: P.5750. Product type: Radionuclide radiation therapy system. Official classification: Class 2. A radionuclide radiation therapy system is a device intended to permit an operator to administer gamma radiation therapy, with the radiation source located at a distance from the patient's body. This generic type of device may include signal analysis and display equipment, patient and equipment supports, treatment planning computer programs, component parts (including beam- limiting devices), and accessories.

Official code: P.5770. Product type: Powered radiation therapy patient support assembly. Official classification: Class 2. A powered radiation therapy patient support assembly is an electrically powered adjustable couch intended to support a patient during radiation therapy.

Official code: P.5780. Product type: Light beam patient position indicator. Official classification: Class 1. A light beam patient position indicator is a device that projects a beam of light (incoherent light or laser) to determine the alignment of the patient with a radiation beam. The beam of light is intended to be used during radiologic procedures toensure proper positioning of the patient and to monitor alignment of the radiation beam with the patient's anatomy.

Official code: P.5840. Product type: Radiation therapy stimulation system. Official classification: Class 2. A radiation therapy simulation system is a fluoroscopic or radiographic x-ray system intended for use in localizing the volume to be exposed during radiation therapy and confirming the position and size of the therapeutic irradiation field produced. Thisgeneric type of device may include signal analysis and display equipment, patient and equipment supports, treatment planning computer programs, component parts, and accessories.

Official code: P.5900. Product type: X-ray radiation therapy system. Official classification: Class 2. An x-ray radiation therapy system is a device intended to produce and control x-rays used for radiation therapy. This generic type of device may include signal analysis and display equipment, patient and equipment supports, treatment planning computer programs, component parts, and accessories.

Official code: P.5930. Product type: Therapeutic x-ray tube housing assembly. Official classification: Class 2. A therapeutic x-ray tube housing assembly is an x-ray generating tube encased in a radiation-shielded housing intended for use in radiation therapy. This generic type of device may include high-voltage and filament transformers or other appropriate components when contained in radiation-shielded housing.

Official code: P.6500. Product type: Personnel protective shield. Official classification: Class 1. A personnel protective shield is a device intended for medical purposes to protect the patient, the operator, or other persons from unnecessary exposure to radiation during radiologic procedures by providingan attenuating barrier to radiation. This generic type of device may include articles of clothing, furniture, and movable or stationary structures.

Official code: P.9999. Product type: Others(Radiology Devices)1,. Official classification: Class 2,3. The products excluded from the above-classification are adopted in this classification and specified by the central competent health authority.