BEUDAMED
    FDA UDI Not in Commercial Distribution 🇺🇸 United States

    Game Ready

    DI: 00812120001085 · Model: 550500-53-RF · 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
    00812120001085
    Version / Model
    550500-53-RF
    Company Name
    Avanos Medical, Inc.
    Labeler DUNS
    079375431
    Distribution Status
    Not in Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2018-01-24
    Public Version
    7
    Public Version Date
    2022-08-03
    Public Version Status
    Update
    Public Device Record Key
    375574d1-5ad4-4222-95a8-ee79460ad8b0
    Distribution End Date
    2022-08-01

    Device Description

    GRPro 2.1 System, OUS, Reconditioned

    Device Characteristics

    Single Use
    No
    Prescription Use (Rx)
    Yes
    Over the Counter (OTC)
    No
    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
    No
    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
    IRP Massager, Powered Inflatable Tube
    ILO Pack, Hot Or Cold, Water Circulating

    GMDN Terms

    Code Name
    60607 Blood refrigerator/freezer

    Identifiers

    Type ID
    Primary 00812120001085