OmniPod Insulin Management Product Demonstration Kit

  • Modèle / numéro de série
    Lot Numbers: L13470
  • Classification du dispositif
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution - USA Nationwide and the country of Israel.
  • Description du dispositif
    OmniPod Insulin Management Product Demonstration Kit; Model Reference Number: (PDK-ZXP490) || Product Usage: || The Demonstration Kit (PDK-ZXP490) is an alternate kit provided to potential patients by healthcare professionals for patients to experience what wearing a Pod may feel like prior to purchase. Each Demonstration Kit includes a UST400 brochure, one Alcohol Pad, and a Pod. The OmniPod 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. The glucose measurements should not be used for the diagnosis of or screening for diabetes. The PDM glucose meter is intended for single-patient use and should not be shared. Abbott FreeStyle test strips are used with the built-in FreeStyle meter for the quantitative measurement of blood glucose in fresh whole capillary blood from the finger, upper arm and palm. Abbott Freestyle Control Solutions are used to verify that the meter and test-strips are working together properly and that the test is performed correctly.
  • Manufacturer
  • 1 Event

Fabricant

  • Adresse du fabricant
    Insulet Corporation, 9 Oak Park Drive, Bedford MA 01730-1413
  • Société-mère du fabricant (2017)
  • Source
    USFDA