BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    CRP Probe

    DI: 00894912002500 · Model: CRP-10H · KOVEN TECHNOLOGY, INC.
    View on AccessGUDID
    Product Codes
    2
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    CRP Probe
    Primary DI
    00894912002500
    Version / Model
    CRP-10H
    Catalog Number
    CRP-10H
    Company Name
    KOVEN TECHNOLOGY, INC.
    Labeler DUNS
    069261402
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2016-06-22
    Public Version
    4
    Public Version Date
    2021-04-07
    Public Version Status
    Update
    Public Device Record Key
    c589d331-de35-48f3-a376-9b4c3ad639a9

    Device Description

    PW Cardiovascular Doppler probe, 10 MHz

    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
    No
    Has Expiration Date
    No
    Has Donation ID
    No

    Sterilization

    Is Sterile
    No
    Sterilization Prior Use
    Yes
    Sterilization Methods
    Hydrogen Peroxide

    Product Codes

    Code Name
    JAF Monitor, Ultrasonic, Nonfetal
    ITX Transducer, Ultrasonic, Diagnostic

    GMDN Terms

    Code Name
    61226 Invasive vascular ultrasound system probe

    Identifiers

    Type ID
    Primary 00894912002500

    Customer Contacts

    Phone
    314-542-2101
    Email
    [email protected]

    Premarket Submissions

    Submission Number Supplement Number
    K935994 000