BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    McKesson

    DI: 00612479261471 · Model: 181-37010 · MCKESSON MEDICAL-SURGICAL INC.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    3
    Identifiers
    3
    Pkg Device Count
    10

    Basic Information

    Brand Name
    McKesson
    Primary DI
    00612479261471
    Version / Model
    181-37010
    Company Name
    MCKESSON MEDICAL-SURGICAL INC.
    Labeler DUNS
    023904428
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    10
    Record Status
    Published
    Publish Date
    2023-05-23
    Public Version
    1
    Public Version Date
    2023-05-31
    Public Version Status
    New
    Public Device Record Key
    84d99949-b310-4a3b-ac2c-2c738df0e097

    Device Description

    TEST KIT, H PYLORI (10/KT)

    Device Characteristics

    Single Use
    Yes
    Prescription Use (Rx)
    Yes
    Over the Counter (OTC)
    No
    Kit
    Yes
    Combination Product
    No
    HCT/P
    No
    Contains NRL
    No
    Not Made with NRL
    Yes
    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
    LYR Helicobacter Pylori

    GMDN Terms

    Code Name
    51012 Helicobacter pylori immunoglobulin M (IgM) antibody IVD, kit, enzyme immunoassay (EIA)
    51004 Helicobacter pylori immunoglobulin A (IgA) antibody IVD, kit, enzyme immunoassay (EIA)
    51008 Helicobacter pylori immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)

    Identifiers

    Type ID
    Package 00612479261488
    Primary 00612479261471
    Unit of Use 00612479261464