BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Globe Scientific

    DI: 00840095606370 · Model: 5123 · GLOBE SCIENTIFIC INC.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    2
    Pkg Device Count
    450

    Basic Information

    Brand Name
    Globe Scientific
    Primary DI
    00840095606370
    Version / Model
    5123
    Company Name
    GLOBE SCIENTIFIC INC.
    Labeler DUNS
    106793995
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    450
    Record Status
    Published
    Publish Date
    2019-11-26
    Public Version
    2
    Public Version Date
    2020-11-19
    Public Version Status
    Update
    Public Device Record Key
    123f26d9-c078-4953-aaa2-ee6af6442ff6

    Device Description

    COBAS MIRA: Cuvette, Racked, for use with Cobas Mira, Mira S, Mira Plus and Horiba ABX changer analyzers, 15/Rack, 30 Racks/Unit

    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
    No
    Has Lot/Batch Number
    Yes
    Has Manufacturing Date
    No
    Has Expiration Date
    No
    Has Donation ID
    No

    Sterilization

    Is Sterile
    No
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    LXG Equipment, Laboratory, General Purpose, Labeled Or Promoted For A Specific Medical Use

    GMDN Terms

    Code Name
    61032 Laboratory analyser cuvette IVD, single-use

    Identifiers

    Type ID
    Primary 00840095606370
    Unit of Use 00840095611268