BEUDAMED
    FDA Registration Active 🇺🇸 United States

    P3T Abdomen

    Reg #: 3004056159 · FEI: 3004056159 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    16
    Establishment Types
    2
    Classifications
    1

    Registration Details

    Registration Name
    Bayer Medical Care Inc.
    Registration Number
    3004056159
    FEI Number
    3004056159
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    625 Alpha Dr
    City
    Pittsburgh
    State
    PA
    ZIP
    15238
    Country
    US

    Regulatory Submissions

    510(k) Number
    K182273

    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

    P3T Abdomen MEDRAD® Stellant Imaging System Interface Module P3T PA Connect.CT MEDRAD Stellant FLEX CT Injection System with Certegra Workstation MEDRAD Stellant FLEX Syringe Kits P3T Cardiac MEDRAD Stellant Connector Tubing MEDRAD Stellant CT Injection System with Certegra Workstation MEDRAD Stellant Syringe Kits MEDRAD Stellant Single Syringe with QFT (SSS-QFT) MEDRAD Stellant Dual Syringe Quad-Pak with a Large Saline Spike and a Small Contrast Spike (SDS-CTP-SCS) Imaging System Interface - ISI2 Module MEDRAD Stellant FLEX 150 mL Sterile Disposable Syringe with Spike (FLEXS-150-SPK) MEDRAD Stellant Single Syringe Tri-Pak with Spike (SSS-CTP-SPK) MEDRAD Stellant Single Syringe Tri-Pak with QFT (SSS-CTP-QFT)

    Establishment Types

    Remanufacture Medical Device Manufacture Medical Device