BEUDAMED
    FDA UDI Not in Commercial Distribution 🇺🇸 United States

    Sensititre

    DI: 05032384561742 · Model: GNUR5F · TREK DIAGNOSTIC SYSTEMS LIMITED
    View on AccessGUDID
    Product Codes
    2
    GMDN Terms
    1
    Identifiers
    2
    Pkg Device Count
    10

    Basic Information

    Brand Name
    Sensititre
    Primary DI
    05032384561742
    Version / Model
    GNUR5F
    Company Name
    TREK DIAGNOSTIC SYSTEMS LIMITED
    Labeler DUNS
    298203498
    Distribution Status
    Not in Commercial Distribution
    Device Count in Pkg
    10
    Record Status
    Published
    Publish Date
    2024-07-24
    Public Version
    2
    Public Version Date
    2025-03-31
    Public Version Status
    Update
    Public Device Record Key
    bd98e4f8-5a3a-4901-ba93-fefc37490f2e
    Distribution End Date
    2025-03-28

    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
    Yes
    Has Expiration Date
    Yes
    Has Donation ID
    No

    Sterilization

    Is Sterile
    No
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    JWY Manual Antimicrobial Susceptibility Test Systems
    LTT Panels, Test, Susceptibility, Antimicrobial

    GMDN Terms

    Code Name
    63869 Multiple antibacterial susceptibility testing kit IVD

    Identifiers

    Type ID
    Unit of Use 05032384571703
    Primary 05032384561742

    Customer Contacts

    Phone
    8006427029
    Email
    [email protected]

    Premarket Submissions

    Submission Number Supplement Number
    K013368 000