Device Recall pH Blood Gas and Electrolytes Analyzer System

  • 모델명 / 제조번호(시리얼번호)
    Model Numbers: 393-839 (with 933-082 software) and 393-841 (with 933-132 software) All Serial Numbers
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution - US Nationwide including the state of OH.
  • 제품 설명
    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

제조사

  • 제조사 주소
    Sendx Medical Inc, 1945 Palomar Oaks Way, Carlsbad CA 92011-1300
  • 제조사 모회사 (2017)
  • Source
    USFDA