BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    VKR-5

    DI: 00860003561942 · Model: VKR-5 · RADIOMETER AMERICA INC.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    VKR-5
    Primary DI
    00860003561942
    Version / Model
    VKR-5
    Company Name
    RADIOMETER AMERICA INC.
    Labeler DUNS
    086661485
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2020-09-25
    Public Version
    1
    Public Version Date
    2020-10-05
    Public Version Status
    New
    Public Device Record Key
    67c2636d-83ea-4d2a-a455-cb44d7c3deb2

    Device Description

    Kit of QC material for the validation of sensor linear response in ABL90, ABL80 COOX, ABL80 COOX OSM series

    Device Characteristics

    Single Use
    Yes
    Prescription Use (Rx)
    Yes
    Over the Counter (OTC)
    No
    Kit
    Yes
    Combination Product
    Yes
    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
    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
    JJS Controls For Blood-Gases, (Assayed And Unassayed)

    GMDN Terms

    Code Name
    52860 Multiple blood gas/haemoximetry/electrolyte analyte IVD, control

    Identifiers

    Type ID
    Primary 00860003561942

    Customer Contacts

    Phone
    8007360600
    Email
    [email protected]

    Storage Conditions

    Type
    Storage Environment Temperature
    Temperature Range
    2 – 8 Degrees Celsius