BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Premom Smart Basal Thermometer

    DI: 00810038636481 · Model: EBT-380 · EASY HEALTHCARE CORPORATION
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    3
    Pkg Device Count
    1

    Basic Information

    Brand Name
    Premom Smart Basal Thermometer
    Primary DI
    00810038636481
    Version / Model
    EBT-380
    Company Name
    EASY HEALTHCARE CORPORATION
    Labeler DUNS
    080278407
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2024-05-11
    Public Version
    3
    Public Version Date
    2025-07-21
    Public Version Status
    Update
    Public Device Record Key
    cb70c322-59c1-465a-80c5-843f77636a33

    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
    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
    14035 Intermittent electronic patient thermometer

    Identifiers

    Type ID
    Package 10810038636488
    Primary 00810038636481
    Package 20810038636485