Blood Gas Analyzer, Electrolyte
Vietnam·Risk Class TTBYT Loại C·Rapidlab 348EX System·Siemens Healthcare Diagnostics Manufacturing Ltd.·Registered Aug 27, 2024- Analysis ID
- 2402244ĐKLH/BYT-HTTB
- Submission ID
- 000.00.04.G18-220426-0009
- Product Type
- Rapidlab 348EX System
- Product Code
- 10844678
- Manufacturer Country
- UNITED KINGDOM
- Authorized Representative
- CÔNG TY TNHH SIEMENS HEALTHCARE
- Intended Use
- The system is designed to determine pH, pCO2, pO2, Na+, K+, Ca++ or Cl– and Hct in the whole blood samples of individuals treated with heparin. The minimum sample volume is 50 μL. The results are displayed on the touch screen according to pH or H+, mmHg or kPa for pCO2 and pO2, mmol/L for Na+, K+, Ca++ or Cl–, and % for Hct. The system also calculates the following parameters: • Standard and actual bicarbonate (HCO3–std and HCO3–act) • Total carbon dioxide content (ctCO2) • Base excess in blood and interstitial fluid (BE(B) and BE(ecf)) • Estimated oxygen saturation (O2SAT) • Estimated oxygen content (O2CT) • Alveolar-arterial oxygen pressure gradient (pO2(A–a)) and alveolar-arterial oxygen pressure ratio (pO2(a/A)) • Anion gap (AnGap) • Estimated total hemoglobin content (ctHb(est)) • Adjusted calcium ion concentration (Ca++(7,4)) • Oxygen tension in arterial blood to inspired oxygen concentration ratio (pO2/FIO2) The system is also designed to determine pH, pCO2, Na+, K+, and Ca++ in the original acetate and bicarbonate buffer solutions. When used in buffer solution mode, the results are displayed on the touch screen according to pH or H+, mmHg or kPa for pCO2, and mmol/L for Na+, K+, and Ca++. In buffer solution mode, the system will calculate the actual bicarbonate concentration (HCO3–act) and total carbon dioxide content (ctCO2).
- Registration Date
- Aug 27, 2024
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Access comprehensive regulatory information for Blood Gas Analyzer, Electrolyte in Vietnam's medical device market through Pure Global AI's free database. This Risk Class TTBYT Loại C medical device is registered under number 2402244ĐKLH/BYT-HTTB and manufactured by Siemens Healthcare Diagnostics Manufacturing Ltd.. The authorized representative in Vietnam is CÔNG TY TNHH SIEMENS HEALTHCARE.
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