BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    QBit Series Diagnostic Ultrasound System

    DI: 06945121403221 · Model: QBit 5 · 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
    06945121403221
    Version / Model
    QBit 5
    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
    6
    Public Version Date
    2023-04-12
    Public Version Status
    Update
    Public Device Record Key
    f44c5754-5843-43d7-9b39-acc77e8c1edf

    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
    40761 General-purpose ultrasound imaging system

    Identifiers

    Type ID
    Primary 06945121403221
    Package 06945121404655
    Package 06945121404648
    Package 06945121404631
    Package 06945121404501
    Package 06945121404495
    Package 06945121404488
    Package 06945121404471
    Package 06945121404464
    Package 06945121404457
    Package 06945121404440
    Package 06945121404433
    Package 06945121404426
    Package 06945121404419
    Package 06945121404402
    Package 06945121404396
    Package 06945121404518
    Package 06945121404525
    Package 06945121404532
    Package 06945121404549
    Package 06945121404556
    Package 06945121404563
    Package 06945121404570
    Package 06945121404587
    Package 06945121404594
    Package 06945121404600
    Package 06945121404617
    Package 06945121404624

    Premarket Submissions

    Submission Number Supplement Number
    K150861 000