BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Aroma Season

    DI: 06974736970033 · Model: HA-330 · Shanghai GK Industrial Co.,Ltd.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    Aroma Season
    Primary DI
    06974736970033
    Version / Model
    HA-330
    Catalog Number
    003
    Company Name
    Shanghai GK Industrial Co.,Ltd.
    Labeler DUNS
    547295180
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2024-08-20
    Public Version
    1
    Public Version Date
    2024-08-28
    Public Version Status
    New
    Public Device Record Key
    91023dc9-e81a-452b-a76b-28532766ca50

    Device Description

    An ankle brace with heaitng function powered by a 12V adapter.A controller can control the time and temperature.

    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
    Yes
    Has Manufacturing Date
    No
    Has Expiration Date
    Yes
    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
    Primary 06974736970033