BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    HealthSmart

    DI: 00767056185456 · Model: 18-545-000 · D-M-S HOLDINGS, INC.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    3
    Pkg Device Count
    1

    Basic Information

    Brand Name
    HealthSmart
    Primary DI
    00767056185456
    Version / Model
    18-545-000
    Catalog Number
    18-545-000
    Company Name
    D-M-S HOLDINGS, INC.
    Labeler DUNS
    062028220
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2017-02-17
    Public Version
    5
    Public Version Date
    2023-05-08
    Public Version Status
    Update
    Public Device Record Key
    f294ad41-27e1-47e0-b303-7b7d567d37a2

    Device Description

    NON-CONTACT 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
    No
    Has Lot/Batch Number
    Yes
    Has Manufacturing Date
    No
    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 10767056185453
    Package 30767056185457
    Primary 00767056185456

    Premarket Submissions

    Submission Number Supplement Number
    K100488 000
    K161735 000