BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Human Touch

    DI: 00045915010089 · Model: NOVO XT2 CREAM SOFHYDE · Human Touch, LLC
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    Human Touch
    Primary DI
    00045915010089
    Version / Model
    NOVO XT2 CREAM SOFHYDE
    Catalog Number
    100-NOVOXT-014
    Company Name
    Human Touch, LLC
    Labeler DUNS
    019117691
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2023-08-23
    Public Version
    1
    Public Version Date
    2023-08-31
    Public Version Status
    New
    Public Device Record Key
    7443ced1-d6ae-497e-b09e-dc0673e6f237

    Device Description

    A mains electricity (AC-powered) device specifically designed to be used when placed in a bed or chair. It may be fixed into appropriate beds or chairs providing other functions. It will provide a massaging therapeutic effect to the person occupying the bed or chair typically to ease aches and pains in the body. It may be used in an institution, but is typically designed for home use.

    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
    Yes
    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
    ISA Massager, Therapeutic, Electric

    GMDN Terms

    Code Name
    34488 Bed/chair electric massager

    Identifiers

    Type ID
    Primary 00045915010089