BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    E-CUBE

    DI: 08800013520005 · Model: E-CUBE 5 · Alpinion Medical Systems Co., Ltd.
    View on AccessGUDID
    Product Codes
    3
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    E-CUBE
    Primary DI
    08800013520005
    Version / Model
    E-CUBE 5
    Company Name
    Alpinion Medical Systems Co., Ltd.
    Labeler DUNS
    557800655
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2016-09-23
    Public Version
    6
    Public Version Date
    2022-11-16
    Public Version Status
    Update
    Public Device Record Key
    51659ca7-03f5-4ecd-abc4-1d824d517ce8

    Device Characteristics

    Single Use
    No
    Prescription Use (Rx)
    No
    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
    ITX Transducer, Ultrasonic, Diagnostic
    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 08800013520005

    Premarket Submissions

    Submission Number Supplement Number
    K142733 000