BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Omnipod PodPals

    DI: 10385081120234 · Model: POD-X9-990 · INSULET CORPORATION
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    3
    Pkg Device Count
    1

    Basic Information

    Brand Name
    Omnipod PodPals
    Primary DI
    10385081120234
    Version / Model
    POD-X9-990
    Company Name
    INSULET CORPORATION
    Labeler DUNS
    051334402
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2019-07-01
    Public Version
    2
    Public Version Date
    2022-02-28
    Public Version Status
    Update
    Public Device Record Key
    61723978-b4b6-4b35-a50c-948c8e70b9fd

    Device Description

    Omnipod Adhesive Overlay (Podpals)

    Device Characteristics

    Single Use
    Yes
    Prescription Use (Rx)
    No
    Over the Counter (OTC)
    Yes
    Kit
    No
    Combination Product
    No
    HCT/P
    No
    Contains NRL
    No
    Not Made with NRL
    No
    MRI Safety
    Labeling does not contain MRI Safety Information
    Direct Marking Exempt
    No
    PM Exempt
    Yes
    Has Serial Number
    No
    Has Lot/Batch Number
    Yes
    Has Manufacturing Date
    Yes
    Has Expiration Date
    Yes
    Has Donation ID
    No

    Sterilization

    Is Sterile
    Yes
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    KGX Tape And Bandage, Adhesive

    GMDN Terms

    Code Name
    51083 Ambulatory insulin infusion pump/blood glucose analyser system

    Identifiers

    Type ID
    Primary 10385081120234
    Package 20385081120231
    Package 20385083000104