BEUDAMED
    FDA UDI Not in Commercial Distribution 🇺🇸 United States

    Excyte®

    DI: 03661540700613 · Model: ESR Non-Vacuum Tube · ELITechGroup B.V.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    2
    Pkg Device Count
    50

    Let the assistant research this device

    The Research Assistant compiles product codes, classification, clearances and adverse events for this device — and cites every record.

    Free to try · every answer cites its records

    Ask the Research Assistant See examples

    Basic Information

    Brand Name
    Excyte®
    Primary DI
    03661540700613
    Version / Model
    ESR Non-Vacuum Tube
    Company Name
    ELITechGroup B.V.
    Labeler DUNS
    415733737
    Distribution Status
    Not in Commercial Distribution
    Device Count in Pkg
    50
    Record Status
    Published
    Publish Date
    2016-11-24
    Public Version
    3
    Public Version Date
    2021-12-28
    Public Version Status
    Update
    Public Device Record Key
    76f8c9e8-d923-4fca-8b5f-06f0f6fdf1c3
    Distribution End Date
    2021-12-23

    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
    Yes
    Has Expiration Date
    Yes
    Has Donation ID
    No

    Sterilization

    Is Sterile
    No
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    GHC Tube, Sedimentation Rate

    GMDN Terms

    Code Name
    55974 Non-evacuated erythrocyte sedimentation rate (ESR) tube IVD

    Identifiers

    Type ID
    Primary 03661540700613
    Unit of Use 13661540700610