BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Tandem Source

    DI: 00389152106113 · Model: 1011061 · Tandem Diabetes Care, Inc.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    Tandem Source
    Primary DI
    00389152106113
    Version / Model
    1011061
    Catalog Number
    1011061
    Company Name
    Tandem Diabetes Care, Inc.
    Labeler DUNS
    827900809
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2023-06-20
    Public Version
    2
    Public Version Date
    2023-11-03
    Public Version Status
    Update
    Public Device Record Key
    a9ffc0e9-45d1-4c92-a751-f6c65331eb4d

    Device Description

    Tandem Source Web Application v 3.X

    Device Characteristics

    Single Use
    No
    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
    No
    Has Manufacturing Date
    No
    Has Expiration Date
    No
    Has Donation ID
    No

    Sterilization

    Is Sterile
    No
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    PHV Continuous Glucose Monitor Retrospective Data Analysis Software

    GMDN Terms

    Code Name
    64656 Ambulatory insulin infusion pump software, data-display

    Identifiers

    Type ID
    Primary 00389152106113