Devices

Device Recall OmniPod Insulin Management System

  • 모델명 / 제조번호(시리얼번호)
    Lot Codes: L41880, L41881, L41892, L41895,L41897,L41898, L41899,L41900, L41901, L41902, L41903, L41904, L41905, L41906, L41907
  • 의료기기 분류등급
    General Hospital and Personal Use Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution - US Nationwide and countries of Switzerland, Germany, and Israel.
  • 제품 설명
    OmniPod¿, Insulin Management System (US) || Catalog Number: PODZXP420 || Product Usage: || The OmnniPod¿ Insulin Management System is intended for subcutaneous delivery of insulin at set and variable rates for the management of diabetes mellitus in persons requiring insulin and for the quantitative measurement of glucose in fresh whole capillary blood (in vitro) from the finger.
  • Manufacturer
    Insulet Corporation
  • 1 Event

제조사

Insulet Corporation
  • 제조사 주소
    Insulet Corporation, 600 Technology Park Dr Ste 200, Billerica MA 01821-4126
  • 제조사 모회사 (2017)
    Insulet Corporation
  • Source
    USFDA

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

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Device Recall OmniPod Insulin Management System
  • 모델명 / 제조번호(시리얼번호)
    Lot Codes: L41908, L41910, F41935
  • 의료기기 분류등급
    General Hospital and Personal Use Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution - US Nationwide and countries of Switzerland, Germany, and Israel.
  • 제품 설명
    OmniPod¿, Insulin Management System (OUS) || Catalog Number: 14810 || Product Usage: || The OmnniPod¿ Insulin Management System is intended for subcutaneous delivery of insulin at set and variable rates for the management of diabetes mellitus in persons requiring insulin and for the quantitative measurement of glucose in fresh whole capillary blood (in vitro) from the finger.
  • Manufacturer
    Insulet Corporation