BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Excyte

    DI: 03661540304446 · Model: Mini (8mm) · ELITECHGROUP INC.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

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    Basic Information

    Brand Name
    Excyte
    Primary DI
    03661540304446
    Version / Model
    Mini (8mm)
    Catalog Number
    EX-10310
    Company Name
    ELITECHGROUP INC.
    Labeler DUNS
    052423787
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2018-12-26
    Public Version
    2
    Public Version Date
    2022-09-16
    Public Version Status
    Update
    Public Device Record Key
    02fdea3c-9866-4205-80f9-49ee77edc94e

    Device Description

    Automated ESR Analyzer (erythrocyte sedimentation rate)

    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
    No
    Has Expiration Date
    No
    Has Donation ID
    No

    Sterilization

    Is Sterile
    No
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    GKB Device, Automated Sedimentation Rate

    GMDN Terms

    Code Name
    56691 Erthrocyte sedimentation rate (ESR) analyser IVD

    Identifiers

    Type ID
    Primary 03661540304446