BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    BIOBASE

    DI: 06971674869320 · Model: R1:20mL×1 R2:5mL×1 · 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
    06971674869320
    Version / Model
    R1:20mL×1 R2:5mL×1
    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
    2023-07-24
    Public Version
    1
    Public Version Date
    2023-08-01
    Public Version Status
    New
    Public Device Record Key
    6e50c7d7-8e18-4d99-91df-95d13e99d8cc

    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
    MGA Alpha-1 Microglobulin, Antigen, Antiserum, Control

    GMDN Terms

    Code Name
    53924 Alpha-1-microglobulin IVD, reagent

    Identifiers

    Type ID
    Primary 06971674869320