BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Stellant CT Injector System

    Reg #: 2520313 · FEI: 2520313 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    11
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    Bayer Medical Care Inc.
    Registration Number
    2520313
    FEI Number
    2520313
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    1 Bayer Drive
    City
    INDIANOLA
    State
    PA
    ZIP
    15051
    Country
    US

    Regulatory Submissions

    510(k) Number
    K082905

    Owner / Operator

    Firm Name
    Bayer Medical Care Inc.
    Operator Number
    2520313
    Address
    1 Bayer Drive
    City
    Indianola
    State
    PA
    Postal Code
    15051
    Country
    US
    Correspondent
    Troy A Jack

    Products

    Device Name Product Code
    Injector And Syringe, Angiographic DXT

    Proprietary Names

    Stellant CT Injector System Stellant Imaging System Interface for Siemens CT Scanners (ISI 900S) Stellant Imaging System Interface for Toshiba CT Scanners (ISI 800) P3T Cardiac Stellant CT Low Pressure Connector Tubing Stellant with Certegra Workstation Stellant Imaging System Interface for GE CT Scanners (ISI 900G) P3T PA Stellant CT Syringe Kits Stellant Imaging System Interface for Hitachi CT Scanners (ISI 900H) Stellant Imaging System Interface for Philips CT Scanners (ISI 700)

    Establishment Types

    Manufacture Medical Device