BEUDAMED
    FDA UDI Not in Commercial Distribution 🇺🇸 United States

    Exergen Light Touch

    DI: 10834098000409 · Model: LTX-1 · EXERGEN CORPORATION
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    Exergen Light Touch
    Primary DI
    10834098000409
    Version / Model
    LTX-1
    Catalog Number
    133830F
    Company Name
    EXERGEN CORPORATION
    Labeler DUNS
    061266060
    Distribution Status
    Not in Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2016-09-24
    Public Version
    4
    Public Version Date
    2021-12-22
    Public Version Status
    Update
    Public Device Record Key
    6af0a8e9-290a-46f5-8457-8136d518cac5
    Distribution End Date
    2021-04-21

    Device Description

    LTX-1 Oral Calibration Fahrenheit

    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
    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
    17887 Infrared patient thermometer, ear

    Identifiers

    Type ID
    Primary 10834098000409

    Customer Contacts

    Phone
    617-923-9900
    Email
    [email protected]

    Premarket Submissions

    Submission Number Supplement Number
    K882949 000