Taiwan FDA registration eaaabcf89ed22e60876c268f1419f940
"Instrument Laboratory" Gem 5000 blood gas analysis system
TW: "儀器實驗室" 寶石5000血液氣體分析系統
Taiwan·Risk Class 2·INSTRUMENTATION LABORATORY CO.·Registered Oct 18, 2022 – Oct 18, 2027ActiveRegistration details
- Analysis ID
- eaaabcf89ed22e60876c268f1419f940
- Customs Code
- DHA05603586402
Company information
- Manufacturer
- INSTRUMENTATION LABORATORY CO.
- Manufacturer Country
- United States
- Authorized Representative
- Werfen Taiwan Limited
Product details
- Intended Use
- The GEM Premier 5000 is a portable critical care system that allows professionals to rapidly analyze heparinylated whole blood samples at the time of healthcare delivery in a clinical setting and central laboratory. The instrument quantitatively measures pH, pCO2, pO2, sodium, potassium, chloride, ionized calcium, glucose, lactic acid, hematocrit, total bilirubin and CO oxygen saturation (tHb, O2Hb, COHb, MetHb, HHb, sO2) parameters.
- Product Type (Level 1)
- A Clinical chemistry and clinical toxicology
- Product Type (Level 2)
- A.1120 血內氣體(PCO2,PO2)及血液pH值試驗系統
- Import Information
- Input;; QMS/QSD
Dates and status
- Registration Date
- Oct 18, 2022
- Expiry Date
- Oct 18, 2027
About this record
Access comprehensive regulatory information for "Instrument Laboratory" Gem 5000 blood gas analysis system in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 2 medical device is registered under number eaaabcf89ed22e60876c268f1419f940 and manufactured by INSTRUMENTATION LABORATORY CO.. The authorized representative in Taiwan is Werfen Taiwan Limited.
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