BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Bayer Medical Care Inc.

    Reg #: 3004056159 · FEI: 3004056159 · Expires 2026
    View on FDA
    Products
    5
    Proprietary Names
    69
    Establishment Types
    4
    Classifications
    5

    Registration Details

    Registration Name
    Bayer Medical Care Inc.
    Registration Number
    3004056159
    FEI Number
    3004056159
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    625 Alpha Dr
    City
    Pittsburgh
    State
    PA
    ZIP
    15238
    Country
    US

    Regulatory Submissions

    510(k) Number
    K252891

    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
    Medical Device Data System OUG
    Injector And Syringe, Angiographic DXT
    System, X-Ray, Tomography, Computed JAK
    Pump, Infusion FRN
    Injector, Contrast Medium, Automatic IZQ

    Proprietary Names

    MEDRAD Intego Radiation Dose Management Software MEDRAD MRXperion MR Injection System MEDRAD MRXperion MR Injection System Sterile Disposable MRI Kit MEDRAD ISI2 Module (ISI2) P3T Cardiac Connect.CT P3T Abdomen MEDRAD Stellant Connector Tubing P3T PA 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 MEDRAD Intego Patient Administration Set MEDRAD Intego Source Administration Set MEDRAD Intego PET Infusion System Centargo CT Injection Systems Stellant CT Injector System Stellant CT Connector Tubing Stellant CT Syringe Kits MEDRAD® Stellant FLEX Syringe Kits MEDRAD® Stellant FLEX CT Injection System with Certegra Workstation MEDRAD® Stellant Connector Tubing MEDRAD® Stellant CT Injection System with Certegra Workstation MEDRAD® Stellant Syringe Kits ISI Stellant CT Injector System with P3T Cardiac Stellant CT Injector Systtem MEDRAD Centargo CT Injection System MEDRAD Centargo Patient Line MEDRAD Centargo Day Set MEDRAD Centargo Replacement Spike 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 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) Mark 7 Arterion Injection System MEDRAD® Avanta Multi-Patient Sterile Disposable Set (Part 1 of 2) MEDRAD® Avanta Fluid Management Injection System MEDRAD® Avanta Single Patient Disposable Set - Angio MEDRAD® Avanta Hand Controller Sheath MEDRAD® Avanta Single Patient Disposable Set (Transducer Compatible) MEDRAD® Avanta Multi-Patient Disposable Hand Controller MEDRAD® AvantaDisplay Control Unit Sheath MEDRAD® Avanta Multi-Patient Sterile Disposable Set (Part 2 of 2) MEDRAD® Avanta Multi-Patient Disposable Set MEDRAD® Avanta Fluid Management Injection System Foot Controller MEDRAD INTEGO PET INFUSION SYSTEM MEDRAD® Twist & Go Syringe Kit MEDRAD® VFlow Sterile Hand Controller MEDRAD® Mark 7 Arterion Injection System VFlow Software MEDRAD® Spectris Solaris EP MR Injection System MEDRAD® Disposable MRI Kit for 65/115 MR Injector System MEDRAD® Saline Syringe & Tubing for MR Injector System MEDRAD® Spectris Solaris MRI Integral "T" with Check Valve MEDRAD Mark V Provis Injector System MEDRAD Mark V Provis 200mL FasTurn Sterile Disposable Syringe Kit MEDRAD Mark V Provis 150mL FasTurn Sterile Disposable Syringe Kit MEDRAD Mark V Provis 60mL FasTurn Sterile Disposable Syringe Kit

    Establishment Types

    Manufacture Medical Device Remanufacture Medical Device Manufacture Device in the United States for Export Only Manufacture Medical Device for Another Party (Contract Manufacturer)