BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    BIOBASE

    DI: 06971674861850 · Model: R1:64mL×2 R2:16mL×2 · Biobase Biodustry(Shandong)Co., Ltd.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

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    Basic Information

    Brand Name
    BIOBASE
    Primary DI
    06971674861850
    Version / Model
    R1:64mL×2 R2:16mL×2
    Company Name
    Biobase Biodustry(Shandong)Co., Ltd.
    Labeler DUNS
    420046355
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2023-07-21
    Public Version
    1
    Public Version Date
    2023-07-31
    Public Version Status
    New
    Public Device Record Key
    d88ae7f9-be58-4dbb-be48-3715a05522c5

    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
    Yes
    Has Serial Number
    Yes
    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
    CIT Nadh Oxidation/Nad Reduction, Ast/Sgot

    GMDN Terms

    Code Name
    52955 Total aspartate aminotransferase (AST) IVD, reagent

    Identifiers

    Type ID
    Primary 06971674861850