BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Thermo Fisher

    DI: 05051663008822 · Model: GEMINI AS · SHANDON DIAGNOSTICS LIMITED
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    Thermo Fisher
    Primary DI
    05051663008822
    Version / Model
    GEMINI AS
    Company Name
    SHANDON DIAGNOSTICS LIMITED
    Labeler DUNS
    219103512
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2020-09-16
    Public Version
    2
    Public Version Date
    2023-07-06
    Public Version Status
    Update
    Public Device Record Key
    ecfc34f2-c389-4f68-befb-a25b71833449

    Device Description

    HEATED CHINA ONLY (EX-DEMO)

    Device Characteristics

    Single Use
    No
    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
    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
    KPA Slide Stainer, Automated

    GMDN Terms

    Code Name
    15599 Microscope slide stainer IVD

    Identifiers

    Type ID
    Primary 05051663008822