BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    OPTI Accessory Kit

    DI: 00894472000077 · Model: 1 · OPTI MEDICAL SYSTEMS, INC.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    OPTI Accessory Kit
    Primary DI
    00894472000077
    Version / Model
    1
    Catalog Number
    GD7045
    Company Name
    OPTI MEDICAL SYSTEMS, INC.
    Labeler DUNS
    801458279
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2019-08-06
    Public Version
    1
    Public Version Date
    2019-08-14
    Public Version Status
    New
    Public Device Record Key
    1373c3a4-f37d-4c84-a39a-b367936a89a9

    Device Description

    OPTI CCA Analyzer accessory kit

    Device Characteristics

    Single Use
    No
    Prescription Use (Rx)
    Yes
    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
    No
    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
    JJE Analyzer, Chemistry (Photometric, Discrete), For Clinical Use

    GMDN Terms

    Code Name
    56668 Metabolic profile clinical chemistry analyser IVD, portable, semi-automated

    Identifiers

    Type ID
    Primary 00894472000077