BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    HAYSWELL

    DI: 00860036001101 · Model: HP-3000 · Hayswell
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    HAYSWELL
    Primary DI
    00860036001101
    Version / Model
    HP-3000
    Company Name
    Hayswell
    Labeler DUNS
    017094867
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2018-02-02
    Public Version
    3
    Public Version Date
    2020-07-07
    Public Version Status
    Update
    Public Device Record Key
    30ab56b0-46be-4367-b7d1-de961c32c42d

    Device Description

    Powered heating pad. An assembly of mains electricity (AC-powered) devices designed for the transcutaneous application of heat to a localized body site (e.g., joint, limb) to relieve musculoskeletal pain. It consists of an electric heating pad typically made of synthetic fabric materials, and a hand-held control unit used to regulate and monitor the heat. It is normally available [non-prescription] over-the-counter (OTC) for use in the home.

    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
    Yes
    Has Serial Number
    No
    Has Lot/Batch Number
    Yes
    Has Manufacturing Date
    No
    Has Expiration Date
    No
    Has Donation ID
    No

    Sterilization

    Is Sterile
    Yes
    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
    Primary 00860036001101