BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    UltraTRAK Complete 50 Test Strips

    DI: 00385930000017 · Model: TD-4231 · VERTEX DIAGNOSTICS LLC
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

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    Basic Information

    Brand Name
    UltraTRAK Complete 50 Test Strips
    Primary DI
    00385930000017
    Version / Model
    TD-4231
    Company Name
    VERTEX DIAGNOSTICS LLC
    Labeler DUNS
    808107788
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2020-01-23
    Public Version
    2
    Public Version Date
    2026-04-13
    Public Version Status
    Update
    Public Device Record Key
    3736450e-b29f-4a1b-9a0d-509c88fd43fc

    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
    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
    No
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    CGA Glucose Oxidase, Glucose

    GMDN Terms

    Code Name
    53303 Glucose IVD, kit, electrometry

    Identifiers

    Type ID
    Primary 00385930000017

    Premarket Submissions

    Submission Number Supplement Number
    K063212 000