BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    TrackAid

    DI: 00864984000407 · Model: TA-FR401 · TRIWALKER SERVICES LLC
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    TrackAid
    Primary DI
    00864984000407
    Version / Model
    TA-FR401
    Company Name
    TRIWALKER SERVICES LLC
    Labeler DUNS
    080762333
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2017-12-01
    Public Version
    4
    Public Version Date
    2020-12-04
    Public Version Status
    Update
    Public Device Record Key
    dafa487a-3060-4020-9c0e-cebd999f145b

    Device Description

    Dual Mode Digital Infrared Thermometer

    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
    No
    Has Serial Number
    Yes
    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
    FLL Thermometer, Electronic, Clinical

    GMDN Terms

    Code Name
    17888 Infrared patient thermometer, skin

    Identifiers

    Type ID
    Primary 00864984000407

    Premarket Submissions

    Submission Number Supplement Number
    K131243 000
    K172795 000