BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    PG-01

    DI: 00894912002845 · Model: PG-01 · KOVEN TECHNOLOGY, INC.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    PG-01
    Primary DI
    00894912002845
    Version / Model
    PG-01
    Catalog Number
    PG-01
    Company Name
    KOVEN TECHNOLOGY, INC.
    Labeler DUNS
    069261402
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2016-02-25
    Public Version
    3
    Public Version Date
    2018-07-06
    Public Version Status
    Update
    Public Device Record Key
    320ca61e-4ca2-44e8-b1c9-1ee5e44b304b

    Device Description

    PPG Probe for the Smartdop XT Doppler.

    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
    No

    Product Codes

    Code Name
    JOP Transducer, Ultrasonic

    GMDN Terms

    Code Name
    61422 Noninvasive vascular ultrasound system, line-powered

    Identifiers

    Type ID
    Primary 00894912002845

    Customer Contacts

    Phone
    314-542-2101
    Email
    [email protected]

    Premarket Submissions

    Submission Number Supplement Number
    K131623 000