Device Recall pH Blood Gas and Electrolytes Analyzer System

  • Modèle / numéro de série
    Model Numbers: 393-839 (with 933-082 software) and 393-841 (with 933-132 software) All Serial Numbers
  • Classification du dispositif
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution - US Nationwide including the state of OH.
  • Description du dispositif
    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
  • 1 Event

Fabricant

  • Adresse du fabricant
    Sendx Medical Inc, 1945 Palomar Oaks Way, Carlsbad CA 92011-1300
  • Société-mère du fabricant (2017)
  • Source
    USFDA