BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Forehead and Ear Thermometer

    DI: 09351337000043 · Model: GM-400EF · GENERATION GUARD PTY LTD
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    2
    Pkg Device Count
    1

    Basic Information

    Brand Name
    Forehead and Ear Thermometer
    Primary DI
    09351337000043
    Version / Model
    GM-400EF
    Company Name
    GENERATION GUARD PTY LTD
    Labeler DUNS
    743833861
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2016-09-28
    Public Version
    3
    Public Version Date
    2020-12-04
    Public Version Status
    Update
    Public Device Record Key
    e5f52a7e-8a30-4bfd-9bf5-e16c45e1f8e2

    Device Characteristics

    Single Use
    No
    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
    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
    Package 09351337000067
    Primary 09351337000043