Device Recall Instrumentation Laboratory

Fabricant

  • Adresse du fabricant
    Instrumentation Laboratory Co., 113 Hartwell Ave, Lexington MA 02421-3125
  • Source
    USFDA

8 dispositifs médicaux avec un nom similaire

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  • 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
  • Modèle / numéro de série
    Serial Numbers range: 09020100 through 11041157.
  • Classification du dispositif
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution-- USA (nationwide) and the countries of AUSTRALIA, AUSTRIA, BELGIUM, CANADA, CHINA, CZECH REPUBLIC, DENMARK, EGYPT, FINLAND, FRANCE, GERMANY, GREECE , INDONESIA, ISRAEL, ITALY, JAPAN , KOREA, REPUBLIC OF CHINA, MALAYSIA, NETHERLANDS , PHILIPPINES, POLAND, PORTUGAL, SPAIN, SWEDEN, SWITZERLAND, THAILAND ,TURKEY, and UNITED KINGDOM.
  • Description du dispositif
    Instrumentation Laboratory GEM Premier 3500 Blood Gas Analyzer || PN 00026000000 || The GEM Premier 3500 blood gas analyzer is a portable system for use by health care professionals to rapidly analyze whole blood samples at the point of health care delivery in a clinical setting. The instrument provides quantitative measurements of whole blood for pH, pC02, p02, Na+, K+, Ca++, glucose, lactate and hematocrit. These parameters, along with derived parameters, aid in the diagnosis of a patient's acid/base status, oxygen delivery capacity, and electrolyte and metabolite balance.
  • Manufacturer
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