BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    QBit Series Diagnostic Ultrasound System

    DI: 06945121403245 · Model: QBit 7 · 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
    06945121403245
    Version / Model
    QBit 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
    2016-09-24
    Public Version
    5
    Public Version Date
    2022-11-28
    Public Version Status
    Update
    Public Device Record Key
    242815a4-4386-4aea-90bd-898c94c00b17

    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 06945121403245
    Package 06945121405195
    Package 06945121405188
    Package 06945121405171
    Package 06945121405041
    Package 06945121405034
    Package 06945121405027
    Package 06945121405010
    Package 06945121405003
    Package 06945121404990
    Package 06945121404983
    Package 06945121404976
    Package 06945121404969
    Package 06945121404952
    Package 06945121404945
    Package 06945121404938
    Package 06945121405058
    Package 06945121405065
    Package 06945121405072
    Package 06945121405089
    Package 06945121405096
    Package 06945121405102
    Package 06945121405119
    Package 06945121405126
    Package 06945121405133
    Package 06945121405140
    Package 06945121405157
    Package 06945121405164

    Premarket Submissions

    Submission Number Supplement Number
    K150861 000