BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Easy@Home Fuel Cell Breathalyzer

    DI: 00850003180328 · Model: EAT-05FL · EASY HEALTHCARE CORPORATION
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    2
    Pkg Device Count
    1

    Basic Information

    Brand Name
    Easy@Home Fuel Cell Breathalyzer
    Primary DI
    00850003180328
    Version / Model
    EAT-05FL
    Company Name
    EASY HEALTHCARE CORPORATION
    Labeler DUNS
    080278407
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2019-07-31
    Public Version
    1
    Public Version Date
    2019-08-08
    Public Version Status
    New
    Public Device Record Key
    f4e63a44-14af-4d7f-bec4-36198796e5d1

    Device Characteristics

    Single Use
    No
    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
    Yes
    Has Serial Number
    No
    Has Lot/Batch Number
    Yes
    Has Manufacturing Date
    Yes
    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 10850003180325
    Primary 00850003180328