BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Tandem Mobi Autosoft XC Kit

    DI: 00389152854977 · Model: 1018549 · Tandem Diabetes Care, Inc.
    View on AccessGUDID
    Product Codes
    2
    GMDN Terms
    2
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    Tandem Mobi Autosoft XC Kit
    Primary DI
    00389152854977
    Version / Model
    1018549
    Company Name
    Tandem Diabetes Care, Inc.
    Labeler DUNS
    827900809
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2025-12-10
    Public Version
    1
    Public Version Date
    2025-12-18
    Public Version Status
    New
    Public Device Record Key
    6b511104-6394-4646-b100-67d9f61606e1

    Device Description

    AutoSoft XC, 5"/6mm 14 Pack

    Device Characteristics

    Single Use
    Yes
    Prescription Use (Rx)
    Yes
    Over the Counter (OTC)
    No
    Kit
    Yes
    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
    No
    Has Serial Number
    No
    Has Lot/Batch Number
    Yes
    Has Manufacturing Date
    No
    Has Expiration Date
    Yes
    Has Donation ID
    No

    Sterilization

    Is Sterile
    Yes
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    QFG Alternate Controller Enabled Insulin Infusion Pump
    FPA Set, Administration, Intravascular

    GMDN Terms

    Code Name
    35833 Electric infusion pump administration set, single-use
    35838 Ambulatory insulin infusion pump reservoir

    Identifiers

    Type ID
    Primary 00389152854977