Devices

Device Recall OmniPod Insulin Management System

  • Model / Serial
    Lot Codes: L41908, L41910, F41935
  • Product Classification
    General Hospital and Personal Use Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution - US Nationwide and countries of Switzerland, Germany, and Israel.
  • Product Description
    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
  • 1 Event

Manufacturer

Insulet Corporation
  • Manufacturer Address
    Insulet Corporation, 600 Technology Park Dr Ste 200, Billerica MA 01821-4126
  • Manufacturer Parent Company (2017)
    Insulet Corporation
  • Source
    USFDA

One device with a similar name

Learn more about the data here

Device Recall OmniPod Insulin Management System
  • Model / Serial
    Lot Codes: L41880, L41881, L41892, L41895,L41897,L41898, L41899,L41900, L41901, L41902, L41903, L41904, L41905, L41906, L41907
  • Product Classification
    General Hospital and Personal Use Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution - US Nationwide and countries of Switzerland, Germany, and Israel.
  • Product Description
    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