Device Recall Instrumentation Laboratory

  • Modèle / numéro de série
    All in date cartridges
  • Classification du dispositif
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide distribution: USA (nationwide) and countries of: CANADA, ARGENTINA, AUSTRALIA ,AUSTRIA, BELGIUM, BRAZIL, CHILE, CHINA, CROATIA (local name: Hrvatska), CZECH REPUBLIC, DENMARK, FINLAND, FRANCE, GERMANY, GREECE, GUATEMALA, INDIA, IRELAND, ISRAEL, ITALY, JAPAN, MALAYSIA, MEXICO, NETHERLANDS, NORWAY, PANAMA, POLAND, PORTUGAL, PUERTO RICO, SAUDI ARABIA, SLOVENIA, SPAIN, SWEDEN, SWITZERLAND, TAIWAN, PROVINCE OF CHINA TURKEY, UNITED ARAB EMIRATES, UNITED KINGDOM, URUGUAY, and VIET NAM.
  • Description du dispositif
    GEM PREMIER 4000 CARTRIDGE K+ REPORTING: || GEM 4000 BG/Hct/Lytes/G/L/CO-Ox/tBili : || 75 test iQM Part Number:00027407511 || 150 test iQM Part Number: 00027415011 || 300 test iQM Part Number: 00027430011 || 450 test iQM Part Number: 00027445011 || 600 test iQM part Number: 00027360011 || The GEM Premier 4000 is a portable critical care system for use by health care professionals to rapidly analyze whole blood samples at the point of health care delivery in a clinical setting and in a central laboratory. The instrument provides quantitative measurements of pH, pC02, p02, sodium, potassium, chloride, ionized calcium, glucose, lactate, hematocrit, total bilirubin and CO-Oximetry (tHb, 02Hb, COHb, MetHb, HHb) parameters.
  • Manufacturer
  • 4 Events

Fabricant

  • Adresse du fabricant
    Instrumentation Laboratory Co., 180 Hartwell Road, Bedford MA 01730-2443
  • Société-mère du fabricant (2017)
  • Source
    USFDA

8 dispositifs médicaux avec un nom similaire

En savoir plus sur les données ici

  • Modèle / numéro de série
    Lot Number: 306355 Expires: 8/31/2003
  • Classification du dispositif
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    CA, FL, NY, PA, TN,
  • Description du dispositif
    GEM Premier 3000 Pak pH, pC02, pO2, Hct Sensor and Reagent Cartridge. || Part No. 24330004 (300 Sample Size) || For In-Vitro Diagnostic Use
  • Manufacturer
  • Modèle / numéro de série
    Lot Number: 306360 Expires: 8/31/2003
  • Classification du dispositif
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    CA, FL, NY, PA, TN,
  • Description du dispositif
    GEM Premier 3000 Pak Sensor pH, pC02, pO2, Hct and Reagent Cartridge. || Part No. 24345004 (450 Sample Size) || For In-Vitro Diagnostic Use
  • Manufacturer
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