Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3006791331

FEI Number

3006791331

Entity Name

Bayer Medical Care Inc.

City/State/Country

Saxonburg, PA, US

Establishment Address

150 Victory Road, Saxonburg, PA 16056, US

Establishment Type(s)

Manufacture Medical Device

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

K023183

PMA Number

N/A

All Registered 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 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 P3T Cardiac Stellant CT Syringe Kits Stellant with Certegra Workstation Stellant Imaging System Interface for Toshiba CT Scanners (ISI 800) P3T PA 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 Injector System Stellant CT Connector Tubing Stellant CT Syringe Kits

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
IZQ	Injector, Contrast Medium, Automatic	Cardiovascular	Class 2	870.1650	2018-08-22
DXT	Injector And Syringe, Angiographic	Cardiovascular	Class 2	870.1650	2018-08-22
DXT	Injector And Syringe, Angiographic	Cardiovascular	Class 2	870.1650	2022-04-12
DXT	Injector And Syringe, Angiographic	Cardiovascular	Class 2	870.1650	2011-11-10
DXT	Injector And Syringe, Angiographic	Cardiovascular	Class 2	870.1650	1992-08-20

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
3011334555	Bayer Medical SRL	Barreal de Heredia, CR
3004056159	Bayer Medical Care Inc.	Pittsburgh, PA, US
2520313	Bayer Medical Care Inc.	INDIANOLA, PA, US

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0039-05	Medrad Inc	2	Stellant Syringe Kit. Sterile Disposable Syringe Kits. CT Injector and Accessories. Catalog number SSS-CTP-QFT
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)

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3006791331. Last updated year: 2026. Please use registration number 3006791331 when referencing this establishment in official correspondence.