BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    PRIME SCREEN®

    DI: 00810174471007 · Model: DSODOA-166EUO-5BX-A · WONDFO USA CO., LTD.
    View on AccessGUDID
    Product Codes
    5
    GMDN Terms
    1
    Identifiers
    2
    Pkg Device Count
    5

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    Basic Information

    Brand Name
    PRIME SCREEN®
    Primary DI
    00810174471007
    Version / Model
    DSODOA-166EUO-5BX-A
    Company Name
    WONDFO USA CO., LTD.
    Labeler DUNS
    849098897
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    5
    Record Status
    Published
    Publish Date
    2025-12-05
    Public Version
    1
    Public Version Date
    2025-12-15
    Public Version Status
    New
    Public Device Record Key
    90920967-9a5d-44cc-90cd-5f3fc4db9aa4

    Device Description

    Prime Screen® 6 panel T-swab, AMP,COC,OPI,MET,THC,PCP; 5 per box;

    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
    No
    Has Expiration Date
    Yes
    Has Donation ID
    Yes

    Sterilization

    Is Sterile
    No
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    PUX Test, Amphetamine, Employment And Insurance Testing, Exempt
    PVA Test, Cocaine And Cocaine Metabolite, Employment And Insurance Testing, Exempt
    PVH Test, Opiates, Employment And Insurance Testing, Exempt
    PVD Test, Methamphetamine, Employment And Insurance Testing, Exempt
    PVJ Test, Cannabinoid, Employment And Insurance Testing, Exempt

    GMDN Terms

    Code Name
    46994 Multiple drugs of abuse IVD, kit, rapid ICT, clinical

    Identifiers

    Type ID
    Unit of Use 00810174470994
    Primary 00810174471007