BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    SonoMax Series Digital Color Doppler Ultrasound System

    DI: 06945121415200 · Model: SonoMax 7 · CHISON Medical Technologies Co., Ltd.
    View on AccessGUDID
    Product Codes
    2
    GMDN Terms
    1
    Identifiers
    22
    Pkg Device Count
    1

    Let the assistant research this device

    The Research Assistant compiles product codes, classification, clearances and adverse events for this device — and cites every record.

    Free to try · every answer cites its records

    Ask the Research Assistant See examples

    Basic Information

    Brand Name
    SonoMax Series Digital Color Doppler Ultrasound System
    Primary DI
    06945121415200
    Version / Model
    SonoMax 7
    Company Name
    CHISON Medical Technologies Co., Ltd.
    Labeler DUNS
    544914187
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2024-08-15
    Public Version
    2
    Public Version Date
    2024-10-28
    Public Version Status
    Update
    Public Device Record Key
    4c4657c0-36bd-4c9d-af70-53b69c769e46

    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
    Yes
    Has Expiration Date
    No
    Has Donation ID
    No

    Sterilization

    Is Sterile
    No
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    IYO System, Imaging, Pulsed Echo, Ultrasonic
    IYN System, Imaging, Pulsed Doppler, Ultrasonic

    GMDN Terms

    Code Name
    40761 General-purpose ultrasound imaging system

    Identifiers

    Type ID
    Primary 06945121415200
    Package 06945121415378
    Package 06945121415453
    Package 06945121415361
    Package 06945121415460
    Package 06945121415316
    Package 06945121415354
    Package 06945121415477
    Package 06945121415484
    Package 06945121415491
    Package 06945121415231
    Package 06945121415323
    Package 06945121415330
    Package 06945121415347
    Package 06945121415309
    Package 06945121415507
    Package 06945121415514
    Package 06945121415293
    Package 06945121415248
    Package 06945121415521
    Package 06945121415217
    Package 06945121415224

    Premarket Submissions

    Submission Number Supplement Number
    K233697 000