BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Ultra TRAK TM ULTIMATE TEST STRIP (50 Test Strips)

    DI: 00385930011112 · Model: TD-4277 · VERTEX DIAGNOSTICS LLC
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    Ultra TRAK TM ULTIMATE TEST STRIP (50 Test Strips)
    Primary DI
    00385930011112
    Version / Model
    TD-4277
    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
    1
    Public Version Date
    2020-01-31
    Public Version Status
    New
    Public Device Record Key
    26a24e29-39ba-4f16-a38f-9f8e8aab01d4

    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
    LFR Glucose Dehydrogenase, Glucose

    GMDN Terms

    Code Name
    53303 Glucose IVD, kit, electrometry

    Identifiers

    Type ID
    Primary 00385930011112