BEUDAMED
    FDA UDI Not in Commercial Distribution 🇺🇸 United States

    Globe Scientific

    DI: 00840095607704 · Model: 5512 · GLOBE SCIENTIFIC INC.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    3
    Pkg Device Count
    1000

    Basic Information

    Brand Name
    Globe Scientific
    Primary DI
    00840095607704
    Version / Model
    5512
    Company Name
    GLOBE SCIENTIFIC INC.
    Labeler DUNS
    106793995
    Distribution Status
    Not in Commercial Distribution
    Device Count in Pkg
    1000
    Record Status
    Published
    Publish Date
    2019-11-26
    Public Version
    3
    Public Version Date
    2021-11-18
    Public Version Status
    Update
    Public Device Record Key
    df9a5a13-f9dc-467b-bb40-2de7846ee11b
    Distribution End Date
    2021-11-17

    Device Description

    HITACHI: Sample Cup, for use with Hitachi ES-300 & ES-600 analyzers, 500/Bag, 12 Bags/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
    62225 Assay container IVD, single-use

    Identifiers

    Type ID
    Primary 00840095607704
    Unit of Use 00840095611718
    Package 00840095607711