BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    EBit Series Diagnostic Ultrasound System

    DI: 06945121410861 · Model: EBit 50 · CHISON Medical Technologies Co., Ltd.
    View on AccessGUDID
    Product Codes
    2
    GMDN Terms
    1
    Identifiers
    31
    Pkg Device Count
    1

    Basic Information

    Brand Name
    EBit Series Diagnostic Ultrasound System
    Primary DI
    06945121410861
    Version / Model
    EBit 50
    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
    2017-04-20
    Public Version
    5
    Public Version Date
    2022-09-05
    Public Version Status
    Update
    Public Device Record Key
    f7f2c995-c34b-4291-ac98-266ed436628b

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

    GMDN Terms

    Code Name
    40761 General-purpose ultrasound imaging system

    Identifiers

    Type ID
    Primary 06945121410861
    Package 06945121410878
    Package 06945121410885
    Package 06945121410892
    Package 06945121410908
    Package 06945121410915
    Package 06945121410922
    Package 06945121411059
    Package 06945121411066
    Package 06945121411073
    Package 06945121411080
    Package 06945121411097
    Package 06945121411103
    Package 06945121411110
    Package 06945121411127
    Package 06945121411134
    Package 06945121411141
    Package 06945121411158
    Package 06945121411165
    Package 06945121411042
    Package 06945121411035
    Package 06945121411028
    Package 06945121411011
    Package 06945121411004
    Package 06945121410991
    Package 06945121410984
    Package 06945121410977
    Package 06945121410960
    Package 06945121410953
    Package 06945121410946
    Package 06945121410939

    Premarket Submissions

    Submission Number Supplement Number
    K162172 000