BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Tandem Mobi Adhesive Sleeve

    DI: 00389152076157 · Model: 1010123 · Tandem Diabetes Care, Inc.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    2
    Pkg Device Count
    10

    Basic Information

    Brand Name
    Tandem Mobi Adhesive Sleeve
    Primary DI
    00389152076157
    Version / Model
    1010123
    Company Name
    Tandem Diabetes Care, Inc.
    Labeler DUNS
    827900809
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    10
    Record Status
    Published
    Publish Date
    2023-12-05
    Public Version
    1
    Public Version Date
    2023-12-13
    Public Version Status
    New
    Public Device Record Key
    cf950fc4-c497-4615-8600-a751316afac0

    Device Characteristics

    Single Use
    Yes
    Prescription Use (Rx)
    No
    Over the Counter (OTC)
    No
    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
    No
    Has Expiration Date
    Yes
    Has Donation ID
    No

    Sterilization

    Is Sterile
    No
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    KGX Tape And Bandage, Adhesive

    GMDN Terms

    Code Name
    64891 Ambulatory insulin infusion pump, electronic, software-dosing, scalar algorithm

    Identifiers

    Type ID
    Unit of Use 00389152000961
    Primary 00389152076157