Devices

Device Recall pH Blood Gas and Electrolytes Analyzer System

Model / Serial
Model Numbers: 393-839 (with 933-082 software) and 393-841 (with 933-132 software) All Serial Numbers
Product Classification
Clinical Chemistry and Clinical Toxicology Devices
Device Class
2
Implanted device?
No
Distribution
Worldwide Distribution - US Nationwide including the state of OH.
Product Description
ABL80 FLEX (with FLEX software) and ABL80 FLEX CO-OX (with CO-OX software) - pH Blood Gas and Electrolytes Analyzer System. || Intended Use The ABL80 FLEX (with FLEX software) and ABL80 FLEX CO-OX (with CO-OX software) are portable, automated analyzers that measure pH, blood gases, electrolytes, glucose and oximetry (ABL80 FLEX CO-OX only) in whole blood. The ABL80 FLEX (with FLEX software) and ABL80 FLEX CO-OX (with CO-OX software) analyzer systems are intended for use by trained technologists, nurses, physicians and therapists. They are intended for use in a laboratory environment, near patient or point-of-care setting.
Manufacturer
Sendx Medical Inc
1 Event
- Recall of Device Recall pH Blood Gas and Electrolytes Analyzer System

Manufacturer

Sendx Medical Inc

Manufacturer Address
Sendx Medical Inc, 1945 Palomar Oaks Way, Carlsbad CA 92011-1300
Manufacturer Parent Company (2017)
Danaher Corporation
Source
USFDA

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