BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Healgen (Private Label) - 264

    DI: 00895330002653 · Model: CB-HE-264 · CONFIRM BIOSCIENCES, INC.
    View on AccessGUDID
    Product Codes
    6
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    Healgen (Private Label) - 264
    Primary DI
    00895330002653
    Version / Model
    CB-HE-264
    Company Name
    CONFIRM BIOSCIENCES, INC.
    Labeler DUNS
    806524968
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2016-09-07
    Public Version
    4
    Public Version Date
    2022-06-10
    Public Version Status
    Update
    Public Device Record Key
    f2413a2e-f6eb-47a2-8bb1-087d257ab157

    Device Description

    6 Panel Dip Card - CLIA - COC/AMP/mAMP/THC/OPI/BZO

    Device Characteristics

    Single Use
    Yes
    Prescription Use (Rx)
    No
    Over the Counter (OTC)
    No
    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
    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
    JXM Enzyme Immunoassay, Benzodiazepine
    DJG Enzyme Immunoassay, Opiates
    DKE Reagents, Test, Tetrahydrocannabinol
    DJC Thin Layer Chromatography, Methamphetamine
    DKZ Enzyme Immunoassay, Amphetamine
    DIO Enzyme Immunoassay, Cocaine And Cocaine Metabolites

    GMDN Terms

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

    Identifiers

    Type ID
    Primary 00895330002653