BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Cardiac Calibration Verifiers for Roche Systems

    DI: 00817238011636 · Model: 98505 · CLINIQA CORPORATION
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    Cardiac Calibration Verifiers for Roche Systems
    Primary DI
    00817238011636
    Version / Model
    98505
    Company Name
    CLINIQA CORPORATION
    Labeler DUNS
    078742335
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2020-01-31
    Public Version
    1
    Public Version Date
    2020-02-10
    Public Version Status
    New
    Public Device Record Key
    123fe7fa-a0d4-456e-a5d9-3e6cc41c8954

    Device Description

    Cardiac Calibration Verifiers for Roche Systems

    Device Characteristics

    Single Use
    No
    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
    No
    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
    47016 Multiple cardiac marker IVD, control

    Identifiers

    Type ID
    Primary 00817238011636

    Premarket Submissions

    Submission Number Supplement Number
    K080973 000