BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    QBit Series Diagnostic Ultrasound System

    DI: 06945121403269 · Model: QBit 9 · CHISON Medical Technologies Co., Ltd.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    28
    Pkg Device Count
    1

    Basic Information

    Brand Name
    QBit Series Diagnostic Ultrasound System
    Primary DI
    06945121403269
    Version / Model
    QBit 9
    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
    2016-09-24
    Public Version
    5
    Public Version Date
    2022-11-28
    Public Version Status
    Update
    Public Device Record Key
    49520855-f10a-4f0b-a423-ed9f1dd9feb5

    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

    GMDN Terms

    Code Name
    41917 Foetal Doppler system probe

    Identifiers

    Type ID
    Primary 06945121403269
    Package 06945121405737
    Package 06945121405720
    Package 06945121405713
    Package 06945121405584
    Package 06945121405577
    Package 06945121405560
    Package 06945121405553
    Package 06945121405546
    Package 06945121405539
    Package 06945121405522
    Package 06945121405515
    Package 06945121405508
    Package 06945121405492
    Package 06945121405485
    Package 06945121405478
    Package 06945121405591
    Package 06945121405607
    Package 06945121405614
    Package 06945121405621
    Package 06945121405638
    Package 06945121405645
    Package 06945121405652
    Package 06945121405669
    Package 06945121405676
    Package 06945121405683
    Package 06945121405690
    Package 06945121405706

    Premarket Submissions

    Submission Number Supplement Number
    K150861 000