BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    t:slim X2 Insulin Pump with Control-IQ Technology

    DI: 00389152286815 · Model: 1012868 · Tandem Diabetes Care, Inc.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    t:slim X2 Insulin Pump with Control-IQ Technology
    Primary DI
    00389152286815
    Version / Model
    1012868
    Company Name
    Tandem Diabetes Care, Inc.
    Labeler DUNS
    827900809
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2023-10-20
    Public Version
    1
    Public Version Date
    2023-10-30
    Public Version Status
    New
    Public Device Record Key
    59547393-6f21-43f5-81d9-48ef955df727

    Device Characteristics

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

    Sterilization

    Is Sterile
    No
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    QFG Alternate Controller Enabled Insulin Infusion Pump

    GMDN Terms

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

    Identifiers

    Type ID
    Primary 00389152286815