BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    4D View

    DI: 00840682122788 · Model: 17 · GE Healthcare Austria GmbH & Co OG
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    4D View
    Primary DI
    00840682122788
    Version / Model
    17
    Company Name
    GE Healthcare Austria GmbH & Co OG
    Labeler DUNS
    300599979
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2017-02-08
    Public Version
    3
    Public Version Date
    2018-07-06
    Public Version Status
    Update
    Public Device Record Key
    52dafedd-0ce3-4253-8f66-1474d5ef4da5

    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
    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
    LLZ System, image processing, radiological

    GMDN Terms

    Code Name
    40829 Ultrasound imaging system operation software

    Identifiers

    Type ID
    Primary 00840682122788

    Premarket Submissions

    Submission Number Supplement Number
    K131118 000