BEUDAMED
    FDA UDI Not in Commercial Distribution 🇺🇸 United States

    Excyte®

    DI: 03661540700606 · Model: ESR Vacuum Tube · ELITechGroup B.V.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    2
    Pkg Device Count
    50

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    Basic Information

    Brand Name
    Excyte®
    Primary DI
    03661540700606
    Version / Model
    ESR 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
    9465349f-4b44-4550-88a2-27637d82d5e1
    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
    37558 Evacuated erythrocyte sedimentation rate (ESR) tube IVD

    Identifiers

    Type ID
    Primary 03661540700606
    Unit of Use 13661540700603