Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3004056159

FEI Number

3004056159

Entity Name

Bayer Medical Care Inc.

City/State/Country

Pittsburgh, PA, US

Establishment Address

625 Alpha Dr, Pittsburgh, PA 15238, US

Establishment Type(s)

Manufacture Device in the United States for Export Only

Owner / Operator

Bayer Medical Care Inc. (Owner Number: 2520313)

Owner / Operator Contact Address

1 Bayer Drive, Indianola, PA 15051, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered 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 MRXperion MR Injection System MEDRAD MRXperion MR Injection System Sterile Disposable MRI Kit MEDRAD MRXperion MR Injection System Sterile Disposable MRI Kit MEDRAD MRXperion MR Injection System P3T Abdomen MEDRAD Intego Patient Administration Set MEDRAD Intego Source Administration Set MEDRAD Intego PET Infusion System Centargo CT Injection Systems

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
OUG	Medical Device Data System	General Hospital	Class 1	880.6310	2011-04-18
DXT	Injector And Syringe, Angiographic	Cardiovascular	Class 2	870.1650	2026-02-18
DXT	Injector And Syringe, Angiographic	Cardiovascular	Class 2	870.1650	2022-04-12
DXT	Injector And Syringe, Angiographic	Cardiovascular	Class 2	870.1650	2022-04-12
DXT	Injector And Syringe, Angiographic	Cardiovascular	Class 2	870.1650	2015-08-21
DXT	Injector And Syringe, Angiographic	Cardiovascular	Class 2	870.1650	2013-07-24
JAK	System, X-Ray, Tomography, Computed	Radiology	Class 2	892.1750	2013-07-24
FRN	Pump, Infusion	General Hospital	Class 2	880.5725	2008-06-20
IZQ	Injector, Contrast Medium, Automatic	Cardiovascular	Class 2	870.1650	2021-07-30

Official Correspondent

Troy Jack

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Bayer Medical Care Inc.

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
3006791331	Bayer Medical Care Inc.	Saxonburg, PA, US
3011334555	Bayer Medical SRL	Barreal de Heredia, CR
2520313	Bayer Medical Care Inc.	INDIANOLA, PA, US

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K243523	Siemens Medical Solutions USA, Inc.	NAEOTOM Alpha.Peak/ NAEOTOM Alpha; NAEOTOM Alpha.Pro; NAEOTOM Alpha.Prime	2025-02-12
K781431	General Electric Co.	ELECTRIC CT/T OPERATOR DISPLAY CONSOLE	1978-09-07
K231574	FUJIFILM Healthcare Americas Corporation	Scenaria View 4.2	2023-10-12
K233583	FUJIFILM Healthcare Americas Corporation	FCT iSTREAM Phase 1	2024-04-26
K151376	Covidien, LLC	superDimension Navigation System	2015-11-05

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0008-2008	Lemaitre Vascular, Inc.	2	CVI OZ Palm Injector, used to perfuse contrast media into vessels for angiographic procedures. Ref : OZ 1035 (Cardiovascular Innovations LLC)
Z-0039-05	Medrad Inc	2	Stellant Syringe Kit. Sterile Disposable Syringe Kits. CT Injector and Accessories. Catalog number SSS-CTP-QFT
Z-0007-2011	GE Medical Systems, LLC	2	HiSpeed X/i Computed Tomography operator consoles with the Model Number 2153675 and 2247802. The expected usage of this product is to generate head and whole body CT images of human subjects.
Z-0009-2017	Philips Medical Systems	2	Brilliance 64 CT Model Number 728231 Product Usage: Computed Tomography X-ray systems intended to product cross-sectional images of the body by computer reconstruction of X-ray transmission data taken at different angles and planes.
Z-0010-2017	Philips Medical Systems	2	Ingenuity Core Model Number 728321 Product Usage: Computed Tomography X-ray systems intended to product cross-sectional images of the body by computer reconstruction of X-ray transmission data taken at different angles and planes.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3004056159. Last updated year: 2026. Please use registration number 3004056159 when referencing this establishment in official correspondence.