BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    SoftHeat

    DI: 00328785000191 · Model: HP1000V1 · KAZ USA, INC.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    2
    Pkg Device Count
    1

    Basic Information

    Brand Name
    SoftHeat
    Primary DI
    00328785000191
    Version / Model
    HP1000V1
    Company Name
    KAZ USA, INC.
    Labeler DUNS
    122612547
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2016-07-29
    Public Version
    4
    Public Version Date
    2023-12-18
    Public Version Status
    Update
    Public Device Record Key
    cb05fc2f-1abb-43c7-b976-cfdf8195ae61

    Device Description

    Electric Heat Pad, MaxHeat by SoftHeat, 4 heat settings, 10" x 22", moist even heat, 60 minute auto-off, machine wash entire pad.

    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
    Yes
    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
    IRT Pad, Heating, Powered

    GMDN Terms

    Code Name
    11989 External electric-heating core temperature regulation system pad

    Identifiers

    Type ID
    Package 20328785000195
    Primary 00328785000191

    Customer Contacts

    Phone
    1-800-477-0457
    Email
    [email protected]