BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Bayer Medical Care Inc.

    Reg #: 3006791331 · FEI: 3006791331 · Expires 2026
    View on FDA
    Products
    2
    Proprietary Names
    32
    Establishment Types
    1
    Classifications
    2

    Registration Details

    Registration Name
    Bayer Medical Care Inc.
    Registration Number
    3006791331
    FEI Number
    3006791331
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    150 Victory Road
    City
    Saxonburg
    State
    PA
    ZIP
    16056
    Country
    US

    Regulatory Submissions

    510(k) Number
    K173773

    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, Contrast Medium, Automatic IZQ
    Injector And Syringe, Angiographic DXT

    Proprietary Names

    P3T Abdomen MEDRAD® Stellant FLEX Syringe Kits MEDRAD® Stellant FLEX CT Injection System with Certegra Workstation P3T PA MEDRAD® Stellant Connector Tubing MEDRAD® Stellant CT Injection System with Certegra Workstation P3T Cardiac Connect.CT MEDRAD® Stellant Syringe Kits ISI MEDRAD Stellant Connector Tubing MEDRAD Stellant Syringe Kits MEDRAD Stellant FLEX Syringe Kits MEDRAD Stellant CT Injection System with Certegra Workstation MEDRAD® Stellant Imaging System Interface Module MEDRAD Stellant FLEX CT Injection System with Certegra Workstation MEDRAD Stellant Dual Syringe Quad-Pak with a Large Saline Spike and a Small Contrast Spike (SDS-CTP-SCS) MEDRAD Stellant Single Syringe Tri-Pak with QFT (SSS-CTP-QFT) MEDRAD Stellant Single Syringe Tri-Pak with Spike (SSS-CTP-SPK) MEDRAD Stellant Single Syringe with QFT (SSS-QFT) MEDRAD Stellant FLEX 150 mL Sterile Disposable Syringe with Spike (FLEXS-150-SPK) Imaging System Interface - ISI2 Module Stellant CT Syringe Kits Stellant with Certegra Workstation Stellant Imaging System Interface for Toshiba CT Scanners (ISI 800) Stellant CT Low Pressure Connector Tubing Stellant Imaging System Interface for GE CT Scanners (ISI 900G) Stellant CT Injector System Stellant Imaging System Interface for Siemens CT Scanners (ISI 900S) Stellant Imaging System Interface for Hitachi CT Scanners (ISI 900H) Stellant Imaging System Interface for Philips CT Scanners (ISI 700) Stellant CT Connector Tubing

    Establishment Types

    Manufacture Medical Device