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    FDA UDI In Commercial Distribution 🇺🇸 United States

    CBit Series Digital Color Doppler Ultrasound System

    DI: 06945121412308 · Model: CBit 8 · CHISON Medical Technologies Co., Ltd.
    View on AccessGUDID
    Product Codes
    2
    GMDN Terms
    1
    Identifiers
    30
    Pkg Device Count
    1

    Basic Information

    Brand Name
    CBit Series Digital Color Doppler Ultrasound System
    Primary DI
    06945121412308
    Version / Model
    CBit 8
    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
    2018-08-27
    Public Version
    2
    Public Version Date
    2022-09-05
    Public Version Status
    Update
    Public Device Record Key
    a21736d8-352c-4dd6-9942-883a12ba17a4

    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 06945121412407
    Primary 06945121412308
    Package 06945121412391
    Package 06945121412384
    Package 06945121412667
    Package 06945121412650
    Package 06945121412643
    Package 06945121412636
    Package 06945121412629
    Package 06945121412490
    Package 06945121412483
    Package 06945121412476
    Package 06945121412469
    Package 06945121412452
    Package 06945121412445
    Package 06945121412438
    Package 06945121412421
    Package 06945121412414
    Package 06945121412506
    Package 06945121412513
    Package 06945121412520
    Package 06945121412537
    Package 06945121412544
    Package 06945121412551
    Package 06945121412568
    Package 06945121412575
    Package 06945121412582
    Package 06945121412599
    Package 06945121412605
    Package 06945121412612

    Premarket Submissions

    Submission Number Supplement Number
    K180974 000