BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Oral Temperature Digital Thermometer

    DI: 00612606001512 · Model: 16811 · KERMA MEDICAL PRODUCTS, INC.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    2
    Pkg Device Count
    1

    Basic Information

    Brand Name
    Oral Temperature Digital Thermometer
    Primary DI
    00612606001512
    Version / Model
    16811
    Catalog Number
    16811
    Company Name
    KERMA MEDICAL PRODUCTS, INC.
    Labeler DUNS
    787328772
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2017-08-18
    Public Version
    3
    Public Version Date
    2018-07-06
    Public Version Status
    Update
    Public Device Record Key
    960ae9c9-a430-45b8-b4b8-20083d97dfe4

    Device Description

    Dual Scale Oral Digital Thermometer, 60 second read

    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
    Yes
    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
    14035 Intermittent electronic patient thermometer

    Identifiers

    Type ID
    Package 20612606001516
    Primary 00612606001512

    Premarket Submissions

    Submission Number Supplement Number
    K940686 000