Devices

Device Recall Fresenius FDS08 Dialysate Delivery Machine

제조사

Fresenius Medical Care North America
  • 제조사 주소
    Fresenius Medical Care North America, 920 Winter St, Waltham MA 02451-1521
  • 제조사 모회사 (2017)
    Fresenius SE & Co KGaA
  • Source
    USFDA

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Device Recall Fresenius FDS08 Dialysate Delivery Machine
  • 모델명 / 제조번호(시리얼번호)
    Catalog numbers 501228, R190188 (Refurbished), R501228, RTLR501228 (Refurbished)
  • 의료기기 분류등급
    Gastroenterology-Urology Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Product distributed to 5404 customers throughout the US and the world.
  • 제품 설명
    Fresenius 2008H Dialysate Delivery Machine, Manufactured by Fresenius USA Inc., Walnut Creek, CA
  • Manufacturer
    Fresenius Medical Care North America
Device Recall Fresenius FDS08 Dialysate Delivery Machine
  • 모델명 / 제조번호(시리얼번호)
    Catalog Numbers 190011 (60 Hz main power supply), 190092 (50 Hz main power supply), 150425 (AC power cord assembly -hemodialysis machine) and 160089 (AC power cord assembly, Granuflo 1 mixers)
  • 의료기기 분류등급
    Gastroenterology-Urology Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Product distributed to 5404 customers throughout the US and the world.
  • 제품 설명
    Main Power Supply Assembly (50 and 60 Hz) and AC Power cord assembly for hemodialysis machines and Granuflo 1 mixers, Distributed by Fresenius USA Inc., Walnut Creek, CA
  • Manufacturer
    Fresenius Medical Care North America