BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    U-Catch

    DI: 06972428160809 · Model: U-Catch PLUS Multi-Drug Test Cup · Shenzhen Bioeasy Biotechnology Co., Ltd
    View on AccessGUDID
    Product Codes
    6
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    U-Catch
    Primary DI
    06972428160809
    Version / Model
    U-Catch PLUS Multi-Drug Test Cup
    Catalog Number
    YRLG02501005
    Company Name
    Shenzhen Bioeasy Biotechnology Co., Ltd
    Labeler DUNS
    547954309
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2022-12-08
    Public Version
    2
    Public Version Date
    2023-01-09
    Public Version Status
    Update
    Public Device Record Key
    0ad8ef66-f2dd-42cd-b85a-211d05eaff74

    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
    No
    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
    NFT Test, Amphetamine, Over The Counter
    NFV Test, Benzodiazepine, Over The Counter
    NFY Test, Cocaine And Cocaine Metabolites, Over The Counter
    NGG Test, Methamphetamine, Over The Counter
    NGI Test, Morphine, Over The Counter
    NFW Test, Cannabinoid, Over The Counter

    GMDN Terms

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

    Identifiers

    Type ID
    Primary 06972428160809

    Premarket Submissions

    Submission Number Supplement Number
    K193480 000