BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Game Ready

    DI: 00812120001511 · Model: 620200-03 · Avanos Medical, Inc.
    View on AccessGUDID
    Product Codes
    2
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    Game Ready
    Primary DI
    00812120001511
    Version / Model
    620200-03
    Company Name
    Avanos Medical, Inc.
    Labeler DUNS
    079375431
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2018-01-24
    Public Version
    6
    Public Version Date
    2023-12-18
    Public Version Status
    Update
    Public Device Record Key
    4bfaf97d-a9e5-4807-bbfc-0d3442f64c6d

    Device Description

    ATX, Heat Exchanger, Cooling Vest

    Device Characteristics

    Single Use
    No
    Prescription Use (Rx)
    Yes
    Over the Counter (OTC)
    No
    Kit
    No
    Combination Product
    No
    HCT/P
    No
    Contains NRL
    Yes
    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
    No
    Has Expiration Date
    No
    Has Donation ID
    No

    Sterilization

    Is Sterile
    No
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    IRP Massager, Powered Inflatable Tube
    ILO Pack, Hot Or Cold, Water Circulating

    GMDN Terms

    Code Name
    60708 Circulating-fluid localized thermal/compression therapy system wrap

    Identifiers

    Type ID
    Primary 00812120001511