Devices

Device Recall Instrumentation Laboratory GEM Premier 3500 analyzer

Model / Serial
Serial Numbers range: 09020100 through 11041157.
Product Classification
Clinical Chemistry and Clinical Toxicology Devices
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
Instrumentation Laboratory Co.
1 Event
- Recall of Device Recall Instrumentation Laboratory GEM Premier 3500 analyzer

Manufacturer

Instrumentation Laboratory Co.

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

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