BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Q Series Diagnostic Ultrasound System

    DI: 06945121400039 · Model: Q5 · CHISON Medical Technologies Co., Ltd.
    View on AccessGUDID
    Product Codes
    2
    GMDN Terms
    1
    Identifiers
    29
    Pkg Device Count
    1

    Basic Information

    Brand Name
    Q Series Diagnostic Ultrasound System
    Primary DI
    06945121400039
    Version / Model
    Q5
    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
    2016-09-20
    Public Version
    5
    Public Version Date
    2022-09-05
    Public Version Status
    Update
    Public Device Record Key
    795d1d99-9533-4f7d-9cc6-513ac49f3343

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

    GMDN Terms

    Code Name
    40761 General-purpose ultrasound imaging system

    Identifiers

    Type ID
    Package 06945121401241
    Primary 06945121400039
    Package 06945121401494
    Package 06945121401487
    Package 06945121401470
    Package 06945121401463
    Package 06945121401333
    Package 06945121401326
    Package 06945121401319
    Package 06945121401302
    Package 06945121401296
    Package 06945121401289
    Package 06945121401272
    Package 06945121401265
    Package 06945121401258
    Package 06945121401234
    Package 06945121401227
    Package 06945121401340
    Package 06945121401357
    Package 06945121401364
    Package 06945121401371
    Package 06945121401388
    Package 06945121401395
    Package 06945121401401
    Package 06945121401418
    Package 06945121401425
    Package 06945121401432
    Package 06945121401449
    Package 06945121401456

    Premarket Submissions

    Submission Number Supplement Number
    K153085 000