BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Test Cartridge

    DI: 06944413802940 · Model: BC4 · Edan Instruments, Inc.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    3
    Pkg Device Count
    1

    Basic Information

    Brand Name
    Test Cartridge
    Primary DI
    06944413802940
    Version / Model
    BC4
    Company Name
    Edan Instruments, Inc.
    Labeler DUNS
    529173163
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2016-09-01
    Public Version
    3
    Public Version Date
    2018-07-06
    Public Version Status
    Update
    Public Device Record Key
    90e5375c-c62d-40d0-8dc3-efded23b730a

    Device Characteristics

    Single Use
    Yes
    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
    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
    CHL Electrode Measurement, Blood-Gases (Pco2, Po2) And Blood Ph

    GMDN Terms

    Code Name
    54498 Multiple blood gas analyte IVD, kit, ion-selective electrode (ISE)

    Identifiers

    Type ID
    Primary 06944413802940
    Package 06944413801967
    Package 06944413802957

    Premarket Submissions

    Submission Number Supplement Number
    K151978 000