BEUDAMED
    FDA UDI Not in Commercial Distribution 🇺🇸 United States

    Medical Fitness Research

    DI: 00862835000309 · Model: ET-100B · MSC INNOVATIONS, LLC
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    2
    Pkg Device Count
    1

    Basic Information

    Brand Name
    Medical Fitness Research
    Primary DI
    00862835000309
    Version / Model
    ET-100B
    Company Name
    MSC INNOVATIONS, LLC
    Labeler DUNS
    080378000
    Distribution Status
    Not in Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2017-04-11
    Public Version
    3
    Public Version Date
    2020-07-23
    Public Version Status
    Update
    Public Device Record Key
    474a562f-ee72-4d1c-8e10-a055e00a760a
    Distribution End Date
    2019-12-30

    Device Description

    Ear 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
    No
    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
    14035 Intermittent electronic patient thermometer

    Identifiers

    Type ID
    Package 10862835000306
    Primary 00862835000309