BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Calibration Mixture

    DI: 00860009625938 · Model: 1 · Red Ball Oxygen Co., Inc.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    2
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    Calibration Mixture
    Primary DI
    00860009625938
    Version / Model
    1
    Company Name
    Red Ball Oxygen Co., Inc.
    Labeler DUNS
    049213267
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2022-12-08
    Public Version
    1
    Public Version Date
    2022-12-16
    Public Version Status
    New
    Public Device Record Key
    48ca74e7-9ac2-4fce-b9f3-a202cf83b4ec

    Device Description

    GAS, CALIBRATION (SPECIFIED CONCENTRATION) - Calibration Mixture

    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
    Yes
    MRI Safety
    Labeling does not contain MRI Safety Information
    Direct Marking Exempt
    Yes
    PM Exempt
    Yes
    Has Serial Number
    No
    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
    BXK Gas, Calibration (Specified Concentration)

    GMDN Terms

    Code Name
    35933 Multiple blood gas analyte IVD, calibrator
    56671 Blood gas analyser IVD, point-of-care

    Identifiers

    Type ID
    Primary 00860009625938