BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Clarius Ultrasound Scanner

    DI: 07540205001127 · Model: EC7 HD · Clarius Mobile Health Corp
    View on AccessGUDID
    Product Codes
    3
    GMDN Terms
    1
    Identifiers
    2
    Pkg Device Count
    1

    Basic Information

    Brand Name
    Clarius Ultrasound Scanner
    Primary DI
    07540205001127
    Version / Model
    EC7 HD
    Catalog Number
    99-02-00069, 99-13-00006
    Company Name
    Clarius Mobile Health Corp
    Labeler DUNS
    202522751
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2020-02-28
    Public Version
    1
    Public Version Date
    2020-03-09
    Public Version Status
    New
    Public Device Record Key
    3d1a8887-a558-4519-9dbe-454ebc7a12dc

    Device Description

    High-density transducer type – endocavity array (Clarius Scanner EC7 HD)

    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
    Yes
    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
    No
    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
    ITX Transducer, Ultrasonic, Diagnostic

    GMDN Terms

    Code Name
    60924 Hand-held ultrasound imaging system, body-surface

    Identifiers

    Type ID
    Direct Marking 07540205000946
    Primary 07540205001127