BEUDAMED
    FDA UDI Not in Commercial Distribution 🇺🇸 United States

    Transonic

    DI: 08774660002279 · Model: HQE10FMV · TRANSONIC SYSTEMS INC.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    Transonic
    Primary DI
    08774660002279
    Version / Model
    HQE10FMV
    Company Name
    TRANSONIC SYSTEMS INC.
    Labeler DUNS
    101317451
    Distribution Status
    Not in Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2016-04-28
    Public Version
    4
    Public Version Date
    2021-01-25
    Public Version Status
    Update
    Public Device Record Key
    bc55419a-fc78-4041-9478-fba1feddb624
    Distribution End Date
    2021-01-24

    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
    Yes
    Sterilization Methods
    ["Moist Heat or Steam Sterilization", "Hydrogen Peroxide", "Ethylene Oxide"]

    Product Codes

    Code Name
    DPW Flowmeter, Blood, Cardiovascular

    GMDN Terms

    Code Name
    61227 Invasive vascular ultrasound system

    Identifiers

    Type ID
    Primary 08774660002279

    Premarket Submissions

    Submission Number Supplement Number
    K872048 000