Product Overview

DASH Pod
Omnipod DASH Pod - POD-BLE-11-520


Device Description

A portable, battery-powered, electronic device designed to provide continuous or intermittent subcutaneous delivery of insulin to a patient with diabetes mellitus. It may be badge-like, designed to adhere to skin or clothing (e.g., with a pressure-sensitive adhesive), or worn in a case attached to the belt or carried in a pocket. It includes a reservoir (e.g., a cartridge similar to a syringe), a pumping mechanism, and an infusion-rate controller. The pump infuses microvolume pulses and/or bolus doses of insulin subcutaneously, typically into the abdomen, through a needle or catheter (not included).


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: 20385082000020

    Device Type: Package

    DeviceId Issuing Agency: GS1

    Contains DI Number: 10385082000023

    Package Quantity: 10

    Package Discontinue Date: N/A

    Package Status: In Commercial Distribution

    Package Type: 10 Pack Box


    Device Id: 10385082000023

    Device Type: Direct Marking

    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


    Device Id: 10385082000023

    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


    Device Id: 20385082000051

    Device Type: Package

    DeviceId Issuing Agency: GS1

    Contains DI Number: 10385082000023

    Package Quantity: 5

    Package Discontinue Date: N/A

    Package Status: In Commercial Distribution

    Package Type: 5 Pack Box


    Educational Resources
    Videos