BEUDAMED
    FDA UDI Not in Commercial Distribution 🇺🇸 United States

    co-innovation

    DI: 06970429840638 · Model: ETG-Dipcard · Co-Innovation Biotech Co., Ltd
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    3
    Pkg Device Count
    1

    Basic Information

    Brand Name
    co-innovation
    Primary DI
    06970429840638
    Version / Model
    ETG-Dipcard
    Company Name
    Co-Innovation Biotech Co., Ltd
    Labeler DUNS
    421302978
    Distribution Status
    Not in Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2018-11-19
    Public Version
    1
    Public Version Date
    2018-12-20
    Public Version Status
    New
    Public Device Record Key
    bea20463-d069-4cfc-a4ba-704bef7d0df3
    Distribution End Date
    2018-11-19

    Device Description

    Rapid ETG Test Dipcard

    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
    Yes
    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
    DJZ Devices, Breath Trapping, Alcohol

    GMDN Terms

    Code Name
    60663 Ethyl glucuronide (EtG) IVD, kit, enzyme immunoassay (EIA)

    Identifiers

    Type ID
    Package 16970429840635
    Primary 06970429840638
    Package 36970429840639