BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    VERSATREK 528 W/16 DRAWERS/CTRL MOD

    DI: 00848838096617 · Model: Y52816 · REMEL, INC.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    VERSATREK 528 W/16 DRAWERS/CTRL MOD
    Primary DI
    00848838096617
    Version / Model
    Y52816
    Company Name
    REMEL, INC.
    Labeler DUNS
    065769564
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2023-07-26
    Public Version
    1
    Public Version Date
    2023-08-03
    Public Version Status
    New
    Public Device Record Key
    6f3f8e58-110a-441f-8f57-f34da87e005d

    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
    Labeling does not contain MRI Safety Information
    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
    MDB System, Blood Culturing

    GMDN Terms

    Code Name
    56739 Blood culture analyser IVD

    Identifiers

    Type ID
    Primary 00848838096617