BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Quality Care Suite

    DI: 00195278584441 · Model: 2.0 · GE MEDICAL SYSTEMS, INC.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    Quality Care Suite
    Primary DI
    00195278584441
    Version / Model
    2.0
    Catalog Number
    5833126
    Company Name
    GE MEDICAL SYSTEMS, INC.
    Labeler DUNS
    809785715
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2023-01-24
    Public Version
    2
    Public Version Date
    2023-09-22
    Public Version Status
    Update
    Public Device Record Key
    84b35f44-dffa-4992-9c34-e9f6704ba43f

    Device Description

    Quality Care Suite 2.0, Medical Device

    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
    Yes
    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
    LHO Instrument, quality-assurance, radiologic

    GMDN Terms

    Code Name
    58473 Diagnostic x-ray digital imaging system workstation application software

    Identifiers

    Type ID
    Primary 00195278584441