BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    COAGULATION CONTROL - LEVEL 1 (COAG CONTROL 1)

    DI: 05055273207620 · Model: CG5021 · RANDOX LABORATORIES LIMITED
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    COAGULATION CONTROL - LEVEL 1 (COAG CONTROL 1)
    Primary DI
    05055273207620
    Version / Model
    CG5021
    Company Name
    RANDOX LABORATORIES LIMITED
    Labeler DUNS
    227530649
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2019-06-03
    Public Version
    1
    Public Version Date
    2019-06-11
    Public Version Status
    New
    Public Device Record Key
    ea0a8a5d-3d8f-4272-bd42-ad90d36d51de

    Device Characteristics

    Single Use
    Yes
    Prescription Use (Rx)
    No
    Over the Counter (OTC)
    No
    Kit
    Yes
    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
    No
    Has Expiration Date
    Yes
    Has Donation ID
    No

    Sterilization

    Is Sterile
    No
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    JJY Multi-Analyte Controls, All Kinds (Assayed)

    GMDN Terms

    Code Name
    30590 Multiple coagulation factor IVD, control

    Identifiers

    Type ID
    Primary 05055273207620