Devices

Device Recall Polyflux Revaclear

  • 모델명 / 제조번호(시리얼번호)
    Lot No. C412120501 to C412127501, C413100101 to C413129601, C414100101 to Lots C414119301 and Lot C414120001
  • 의료기기 분류등급
    Gastroenterology-Urology Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution: US (nationwide) including PR, and countries of: CA, BB, BM, BS, DO and LC.
  • 제품 설명
    Polyflux Revaclear Dialyzer, Model Number 110633. || The Polyflux Revaclear¿ and Polyflux Revaclear¿ Max Dialyzers are single use devices intended for the treatment of acute and chronic renal failure by hemodialysis.
  • Manufacturer
    Gambro Renal Products Inc
  • 1 Event

제조사

Gambro Renal Products Inc
  • 제조사 주소
    Gambro Renal Products Inc, 1101 Jeter Ave, Opelika AL 36801-3885
  • 제조사 모회사 (2017)
    Baxter International
  • Source
    USFDA

유사한 이름을 가진 의료기기 1건 유사한 이름을 가진 의료기기 1 건

데이터에 대해 더 자세히 알아보기 여기

Device Recall Polyflux Revaclear
  • 모델명 / 제조번호(시리얼번호)
    Lot No C412207001 to C412209101, C413200101 to C413206001, C414200101 to C414206001
  • 의료기기 분류등급
    Gastroenterology-Urology Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution: US (nationwide) including PR, and countries of: CA, BB, BM, BS, DO and LC.
  • 제품 설명
    Polyflux Revaclear Max Dialyzer, Model Number 110634. || The Polyflux Revaclear¿ and Polyflux Revaclear¿ Max Dialyzers are single use devices intended for the treatment of acute and chronic renal failure by hemodialysis.
  • Manufacturer
    Gambro Renal Products Inc