Device Recall Instrumentation Laboratory GEM Premier 3500 analyzer

  • Model / Serial
    Serial Numbers range: 09020100 through 11041157.
  • Product Classification
  • Device Class
    2
  • Implanted device?
    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.
  • Product Description
    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
  • 1 Event

Manufacturer

  • Manufacturer Address
    Instrumentation Laboratory Co., 180 Hartwell Road, Bedford MA 01730-2443
  • Manufacturer Parent Company (2017)
  • Source
    USFDA