BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    cobas pro B-Gate update Kit

    DI: 07613336164846 · Model: 08763640001 · Roche Diagnostics GmbH
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

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    Basic Information

    Brand Name
    cobas pro B-Gate update Kit
    Primary DI
    07613336164846
    Version / Model
    08763640001
    Catalog Number
    08763640001
    Company Name
    Roche Diagnostics GmbH
    Labeler DUNS
    315028860
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2020-03-20
    Public Version
    3
    Public Version Date
    2022-11-07
    Public Version Status
    Update
    Public Device Record Key
    2d566cec-401d-4f2d-bf81-2e876749fe45

    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
    Yes
    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
    JQP Calculator/data processing module, for clinical use

    GMDN Terms

    Code Name
    61927 Multi-modality clinical specimen analysis system IVD

    Identifiers

    Type ID
    Primary 07613336164846