BEUDAMED
    FDA UDI Not in Commercial Distribution 🇺🇸 United States

    JointVue 3D Echo

    DI: 00850014885007 · Model: 1.0 · JOINTVUE, LLC
    View on AccessGUDID
    Product Codes
    2
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    JointVue 3D Echo
    Primary DI
    00850014885007
    Version / Model
    1.0
    Company Name
    JOINTVUE, LLC
    Labeler DUNS
    117090348
    Distribution Status
    Not in Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2020-01-31
    Public Version
    3
    Public Version Date
    2021-08-24
    Public Version Status
    Update
    Public Device Record Key
    ae11222c-fe88-4e8c-8625-a85aac9ca7b5
    Distribution End Date
    2021-07-31

    Device Description

    3D Echo Software

    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
    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
    LLZ System, Image Processing, Radiological
    IYO System, Imaging, Pulsed Echo, Ultrasonic

    GMDN Terms

    Code Name
    40829 Ultrasound imaging system operation software

    Identifiers

    Type ID
    Primary 00850014885007

    Customer Contacts

    Phone
    8652351241
    Email
    [email protected]

    Premarket Submissions

    Submission Number Supplement Number
    K172513 000