BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    EBit Series Diagnostic Ultrasound System

    DI: 06945121409704 · Model: EBit 60 · CHISON Medical Technologies Co., Ltd.
    View on AccessGUDID
    Product Codes
    2
    GMDN Terms
    1
    Identifiers
    33
    Pkg Device Count
    1

    Basic Information

    Brand Name
    EBit Series Diagnostic Ultrasound System
    Primary DI
    06945121409704
    Version / Model
    EBit 60
    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
    2022-12-06
    Public Version Status
    Update
    Public Device Record Key
    7c6d0db0-1100-4bd3-8abf-60de7eca6a91

    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
    Primary 06945121409704
    Package 06945121410663
    Package 06945121410656
    Package 06945121410649
    Package 06945121410632
    Package 06945121410625
    Package 06945121410618
    Package 06945121410601
    Package 06945121410595
    Package 06945121410465
    Package 06945121410458
    Package 06945121410441
    Package 06945121410434
    Package 06945121410427
    Package 06945121410410
    Package 06945121410403
    Package 06945121410397
    Package 06945121410380
    Package 06945121410373
    Package 06945121410366
    Package 06945121410359
    Package 06945121410472
    Package 06945121410489
    Package 06945121410496
    Package 06945121410502
    Package 06945121410519
    Package 06945121410526
    Package 06945121410533
    Package 06945121410540
    Package 06945121410557
    Package 06945121410564
    Package 06945121410571
    Package 06945121410588

    Premarket Submissions

    Submission Number Supplement Number
    K162172 000