BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Uric Acid Test Strip

    DI: 06935740727006 · Model: PA 11,25strips/vial×2/box · Urit Medical Electronic Co., Ltd.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    2
    Pkg Device Count
    50

    Basic Information

    Brand Name
    Uric Acid Test Strip
    Primary DI
    06935740727006
    Version / Model
    PA 11,25strips/vial×2/box
    Company Name
    Urit Medical Electronic Co., Ltd.
    Labeler DUNS
    653742429
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    50
    Record Status
    Published
    Publish Date
    2024-07-12
    Public Version
    1
    Public Version Date
    2024-07-22
    Public Version Status
    New
    Public Device Record Key
    9868e567-f1af-40de-acd9-31ea03e70704

    Device Characteristics

    Single Use
    Yes
    Prescription Use (Rx)
    No
    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
    Yes
    Has Serial Number
    No
    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
    JHC Acid, Uric, Uricase (Oxygen Rate)

    GMDN Terms

    Code Name
    62221 Uric acid monitoring system IVD, home-use

    Identifiers

    Type ID
    Primary 06935740727006
    Unit of Use 86935740727002

    Storage Conditions

    Type
    Storage Environment Temperature
    Temperature Range
    2 – 30 Degrees Celsius