BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Checkpoint

    DI: G354CCP044103 · Model: CP04 · Alcopro Inc.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    3
    Pkg Device Count
    100

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    Basic Information

    Brand Name
    Checkpoint
    Primary DI
    G354CCP044103
    Version / Model
    CP04
    Catalog Number
    CCP04410
    Company Name
    Alcopro Inc.
    Labeler DUNS
    113044739
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    100
    Record Status
    Published
    Publish Date
    2022-09-22
    Public Version
    1
    Public Version Date
    2022-09-30
    Public Version Status
    New
    Public Device Record Key
    1cd475a1-9476-4456-a966-c87a7d2dfe47

    Device Description

    Disposable breath alcohol test

    Device Characteristics

    Single Use
    Yes
    Prescription Use (Rx)
    No
    Over the Counter (OTC)
    Yes
    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
    No
    Has Manufacturing Date
    No
    Has Expiration Date
    No
    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
    36041 Alcohol breath analyser

    Identifiers

    Type ID
    Package G354CCP044104
    Primary G354CCP044103
    Unit of Use G354CCP044100

    Premarket Submissions

    Submission Number Supplement Number
    K102225 000