BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    ATI, Inc.

    DI: 00029431000045 · Model: C-8786 · AMERICAN THERMAL INSTRUMENTS, INC.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    2
    Pkg Device Count
    1

    Basic Information

    Brand Name
    ATI, Inc.
    Primary DI
    00029431000045
    Version / Model
    C-8786
    Company Name
    AMERICAN THERMAL INSTRUMENTS, INC.
    Labeler DUNS
    004200824
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2020-09-30
    Public Version
    3
    Public Version Date
    2021-01-06
    Public Version Status
    Update
    Public Device Record Key
    43116ae9-0098-4a06-88a8-45c073e15536

    Device Description

    Disposable Forehead Thermometer

    Device Characteristics

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

    Sterilization

    Is Sterile
    No
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    KPD Strip, Temperature, Forehead, Liquid Crystal

    GMDN Terms

    Code Name
    35899 Colour-indication patient thermometer

    Identifiers

    Type ID
    Primary 00029431000045
    Package 10029431000042