BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    eBuricacid

    DI: 04712558761116 · Model: eB-U01 · VISGENEER, INC.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    eBuricacid
    Primary DI
    04712558761116
    Version / Model
    eB-U01
    Company Name
    VISGENEER, INC.
    Labeler DUNS
    656031619
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2023-07-05
    Public Version
    1
    Public Version Date
    2023-07-13
    Public Version Status
    New
    Public Device Record Key
    ad0a9f5b-59cc-41d7-b2ad-48a3e4959e25

    Device Description

    blood uric acid monitoring system contains meter 1pcs, test strip 25pcs, lancing device 1pcs and lancet 25pcs

    Device Characteristics

    Single Use
    No
    Prescription Use (Rx)
    No
    Over the Counter (OTC)
    Yes
    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
    Yes
    Has Serial Number
    Yes
    Has Lot/Batch Number
    No
    Has Manufacturing Date
    Yes
    Has Expiration Date
    No
    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 04712558761116