BEUDAMED
    FDA UDI Not in Commercial Distribution 🇺🇸 United States

    2 MHz monitoring

    DI: 07290016880304 · Model: 2 MHz monitoring , 5 meter cable · VIASONIX LTD
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    2 MHz monitoring
    Primary DI
    07290016880304
    Version / Model
    2 MHz monitoring , 5 meter cable
    Company Name
    VIASONIX LTD
    Labeler DUNS
    533070236
    Distribution Status
    Not in Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2019-06-07
    Public Version
    1
    Public Version Date
    2019-06-17
    Public Version Status
    New
    Public Device Record Key
    15ac0db9-ef49-4e29-b094-1c9e3dab3330
    Distribution End Date
    2019-06-14

    Device Description

    2 MHz monitoring probe is an ultrasonic transducer which generate acoustic signals and also detect returned signals that intended to be used in combination with the Dolphin system for noninvasive measurements of blood flow velocities in arteries and veins

    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
    ITX Transducer, Ultrasonic, Diagnostic

    GMDN Terms

    Code Name
    40761 General-purpose ultrasound imaging system

    Identifiers

    Type ID
    Primary 07290016880304

    Premarket Submissions

    Submission Number Supplement Number
    K191023 000