BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Easy@Home Heat TENS unit with Replacement Pads

    DI: 00855944007666 · Model: ETP018 · EASY HEALTHCARE CORPORATION
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    3
    Pkg Device Count
    2

    Basic Information

    Brand Name
    Easy@Home Heat TENS unit with Replacement Pads
    Primary DI
    00855944007666
    Version / Model
    ETP018
    Company Name
    EASY HEALTHCARE CORPORATION
    Labeler DUNS
    080278407
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    2
    Record Status
    Published
    Publish Date
    2019-08-01
    Public Version
    3
    Public Version Date
    2022-11-28
    Public Version Status
    Update
    Public Device Record Key
    9b4e69ac-b07c-4f04-bee3-54bafc457000

    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
    IRT Pad, Heating, Powered

    GMDN Terms

    Code Name
    62194 Electric pad localized-body heating system

    Identifiers

    Type ID
    Package 10855944007663
    Primary 00855944007666
    Unit of Use 90855944007669