BEUDAMED
    FDA UDI Not in Commercial Distribution 🇺🇸 United States

    Identify Health Drug Screen Test Cup

    DI: 10850013037008 · Model: BC-US1-BUP-1-AZ25 · MEDICAL DISTRIBUTION GROUP INC
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    2
    Pkg Device Count
    25

    Basic Information

    Brand Name
    Identify Health Drug Screen Test Cup
    Primary DI
    10850013037008
    Version / Model
    BC-US1-BUP-1-AZ25
    Catalog Number
    BC-US1-BUP-1-AZ25
    Company Name
    MEDICAL DISTRIBUTION GROUP INC
    Labeler DUNS
    064177324
    Distribution Status
    Not in Commercial Distribution
    Device Count in Pkg
    25
    Record Status
    Published
    Publish Date
    2025-10-31
    Public Version
    2
    Public Version Date
    2025-12-05
    Public Version Status
    Update
    Public Device Record Key
    92a70588-1e87-4c3d-9cd0-5d9484846618
    Distribution End Date
    2025-12-04

    Device Description

    Boulder Care, Inc., 1 Panel Drug Screen Test Cup, CLIA WAIVED - MADE IN USA (BUP10) Contents: Test Cups - 25, Package Insert - 1, Security Seals – 25. For In Vitro Diagnostics Use Only.

    Device Characteristics

    Single Use
    Yes
    Prescription Use (Rx)
    Yes
    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
    No
    Has Expiration Date
    Yes
    Has Donation ID
    No

    Sterilization

    Is Sterile
    No
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    DJG Enzyme Immunoassay, Opiates

    GMDN Terms

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

    Identifiers

    Type ID
    Unit of Use 00850013037001
    Primary 10850013037008