OmniPod Insulin Management System Starter Kit

  • Model / Serial
    Lot Numbers: L13483, L13485, L13478, & L13481
  • Product Classification
  • Device Class
  • Implanted device?
  • Distribution
    Worldwide Distribution - USA Nationwide and the country of Israel.
  • Product Description
    OmniPod Insulin Management System Starter Kit; Model Reference Number: SKT-UST400 (Starter Kit) || Product Usage: The Starter Kit (SKT-UST400) is provided to users as an introduction to the OmniPod Insulin Management System prior to initiating care. It includes the Personal Diabetes Manager (PDM) with two AAA alkaline batteries, a USB cable, a Users Guide, a Soft Carrying Case, a Troubleshooting guide, a Warranty Registration Card, and two Alcohol Pads. 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


  • Manufacturer Address
    Insulet Corporation, 9 Oak Park Drive, Bedford MA 01730-1413
  • Manufacturer Parent Company (2017)
  • Source