Omnipod Go Insulin Delivery Device 35U/day


Product Overview

Omnipod Go Insulin Delivery Device 35U/day
Omnipod Go Insulin Delivery Device 35U/day - POD-INS-I1-3525


Device Description

A badge-like, battery-powered, disposable device designed to adhere to skin or clothing (e.g., with a pressure-sensitive adhesive) to provide basal and/or periodic bolus subcutaneous delivery of insulin to a patient with diabetes mellitus. The device integrates an electromechanical pumping unit, an insulin reservoir filled by the patient, and an administration cannula/needle; it is patient operated with the use of integral controls or a remote control unit (not included). This is a single-use device.


Environmental Conditions

  • Storage Environment Atmospheric Pressure - KiloPascal
    • 1060.00
    • 700.00
  • Storage Environment Humidity - Percent (%) Relative Humidity
    • 85.00
    • 20.00
  • Storage Environment Temperature - Degrees Fahrenheit
    • 86.00
    • 32.00

  • Device Sizes

    No Data Available


    Device Sterilization

    Device Sterile: True

    Sterilization Prior To Use: False

    Sterilization Methods: No Data Available


    Product Codes

    Code: LZG

    Device Name: Pump, Infusion, Insulin

    Device Class: 2

    Physical State: N/A

    Definition: N/A

    Submission Type ID: 1

    Review Panel: CH

    Review Code: N/A

    Technical Method: N

    Gmp Exempt Flag: N/A

    Life Sustain Support Flag: N

    Unclassified Reason: N/A

    Implant Flag: N

    Target Area: N/A

    Regulation Number: 880.5725

    Third Party Flag: N

    Medical Specialty: HO


    Device Identifiers

    Device Id: 20385084000356

    Device Type: Package

    DeviceId Issuing Agency: GS1

    Contains DI Number: 10385084000359

    Package Quantity: 5

    Package Discontinue Date: N/A

    Package Status: In Commercial Distribution

    Package Type: 5 Pack Box


    Device Id: 10385084000359

    Device Type: Primary

    DeviceId Issuing Agency: GS1

    Contains DI Number: N/A

    Package Quantity: N/A

    Package Discontinue Date: N/A

    Package Status: N/A

    Package Type: N/A


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