Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

2520313

FEI Number

2520313

Entity Name

Bayer Medical Care Inc.

City/State/Country

INDIANOLA, PA, US

Establishment Address

1 Bayer Drive, INDIANOLA, PA 15051, US

Establishment Type(s)

Complaint File Establishment per 21 CFR 820.198

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

K022431

PMA Number

N/A

All Registered Proprietary Names

MEDRAD Spectris MR Injector System MEDRAD Spectris MRI Disposable Kits Vistron CT Injector System 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 Continuum Microbore Administration Sets Burnett TMJ Appliance Mark 7 Arterion Injection System CT TRI-PAK Sterile Disposable Syringe Kit Low Pressure Connector Tubing Mark V ProVis Angiographic Injection System Mark V Plus Injector Mark V ProVis Syringe Kits P3T Abdomen MEDRAD Twist & Go High Pressure Connector Tubing MEDRAD MRXperion MR Injection System Sterile Disposable MRI Kit MEDRAD MRXperion MR Injection System MEDRAD Stellant 250cm Single Patient Disposable (SSS-SPD-250) MEDRAD MRXperion MR Injection System Sterile Disposable MRI Kit (XP 115 VS) MEDRAD Avanta Multi-Patient Disposable Syringe (AVA 500 SYR PART 1 OF 2) MEDRAD Stellant Multi-Patient Kit (SDS MP1) MEDRAD Stellant Multi-Patient Kit (SDS MP2) MEDRAD Stellant Dual Syringe Kit with Dual Check Valve Transfer Set (SDS-TRF-CV) MEDRAD MRXperion Multi-Patient Kit (XP MP) MEDRAD MRXperion 250cm Single Patient Disposable (XP SP) Low Pressure Connector Tubing 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 50 cm Low Pressure Connector Tube Veris® MR Vital Signs Monitor Quick Fill Tube (QFT) MEDRAD MRXperion MR Injection System MEDRAD MRXperion MR Injection System Sterile Disposable MRI Kit MEDRAD ISI2 Module (ISI2) 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® Imaging Bulk Package Transfer Set MEDRAD Dual Check Valve Transfer Set MEDRAD MR Transfer Set Stellant CT Injector System Stellant CT Connector Tubing Stellant CT Syringe Kits High Pressure Connector Tube Extravasation Detection System (XDS) MEDRAD Intego Radiation Dose Management Software Universal Adjustable T-Rail Table Bracket MEDRAD Cascade Transfer Set with Dual Check Valve (JTS-DCV) MEDRAD Stopcock Transfer Set MEDRAD Dual Check Valve Transfer Set for MR (MRTS) MEDRAD Dual Check Valve Transfer Set MEDRAD MR Transfer Set MEDRAD Dual Check Valve Transfer Set for CT (CVTS) MEDRAD Centargo Patient Line MEDRAD Centargo CT Injection System MEDRAD ISI2 Module (ISI2) MEDRAD Centargo Day Set MEDRAD Centargo Replacement Spike Overhead Counterpoise System (OCS) Disposable MRI Kit with Check Valve MEDRAD INTEGO PET INFUSION SYSTEM MEDRAD® XDS Patient Interface Disposable Continuum Secondary MR Administration Kit Continuum Primary MR Administration Kit Continuum MR Infusion System with Wireless Remote Manual Syringe Loader Low Pressure Connector Tubing MEDRAD Intego Patient Administration Set MEDRAD Intego Source Administration Set MEDRAD Intego PET Infusion System 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) MEDRAD Imaging System Interface (ISI 700) Female Luer Transfer Set

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
DXT	Injector And Syringe, Angiographic	Cardiovascular	Class 2	870.1650	2016-12-09
DXT	Injector And Syringe, Angiographic	Cardiovascular	Class 2	870.1650	2011-05-19
DXT	Injector And Syringe, Angiographic	Cardiovascular	Class 2	870.1650	2007-12-06
FPA	Set, Administration, Intravascular	General Hospital	Class 2	880.5440	2013-07-30
EAG	Cephalometer	Dental	Class 2	872.1830	2008-12-16
DXT	Injector And Syringe, Angiographic	Cardiovascular	Class 2	870.1650	2014-08-13
DXT	Injector And Syringe, Angiographic	Cardiovascular	Class 2	870.1650	1992-08-20
DXT	Injector And Syringe, Angiographic	Cardiovascular	Class 2	870.1650	2007-12-06
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
FPK	Tubing, Fluid Delivery	General Hospital	Class 2	880.5440	2014-01-21
DXT	Injector And Syringe, Angiographic	Cardiovascular	Class 2	870.1650	2015-08-21
DXT	Injector And Syringe, Angiographic	Cardiovascular	Class 2	870.1650	2022-04-05
DOY	Radioimmunoassay, Digoxin (3-H), Goat Antibody, 2nd Antibody Sep.	Clinical Toxicology	Class 2	862.3320	2014-08-13
DXT	Injector And Syringe, Angiographic	Cardiovascular	Class 2	870.1650	2022-04-12
FPK	Tubing, Fluid Delivery	General Hospital	Class 2	880.5440	2022-04-04
MWI	Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)	Cardiovascular	Class 2	870.2300	2009-12-15
DXT	Injector And Syringe, Angiographic	Cardiovascular	Class 2	870.1650	2009-01-14
DXT	Injector And Syringe, Angiographic	Cardiovascular	Class 2	870.1650	2026-02-18
DXT	Injector And Syringe, Angiographic	Cardiovascular	Class 2	870.1650	2007-12-06
PQH	Iodinated Contrast Media Transfer Tubing Set	General Hospital	Class 2	880.5440	2018-07-19
PQH	Iodinated Contrast Media Transfer Tubing Set	General Hospital	Class 2	880.5440	2022-05-27
DXT	Injector And Syringe, Angiographic	Cardiovascular	Class 2	870.1650	1992-08-20
DWE	Tubing, Pump, Cardiopulmonary Bypass	Cardiovascular	Class 2	870.4390	2014-01-24
IZQ	Injector, Contrast Medium, Automatic	Cardiovascular	Class 2	870.1650	2007-12-06
OUG	Medical Device Data System	General Hospital	Class 1	880.6310	2011-04-18
DXT	Injector And Syringe, Angiographic	Cardiovascular	Class 2	870.1650	2014-08-13
PQH	Iodinated Contrast Media Transfer Tubing Set	General Hospital	Class 2	880.5440	2019-04-10
IZQ	Injector, Contrast Medium, Automatic	Cardiovascular	Class 2	870.1650	2024-12-09
DXT	Injector And Syringe, Angiographic	Cardiovascular	Class 2	870.1650	2024-12-09
JAK	System, X-Ray, Tomography, Computed	Radiology	Class 2	892.1750	2007-12-06
LNH	System, Nuclear Magnetic Resonance Imaging	Radiology	Class 2	892.1000	2013-01-22
FRN	Pump, Infusion	General Hospital	Class 2	880.5725	2010-12-29
KGX	Tape And Bandage, Adhesive	General Hospital	Class 1	880.5240	2016-09-13
FRN	Pump, Infusion	General Hospital	Class 2	880.5725	2008-06-20
DXT	Injector And Syringe, Angiographic	Cardiovascular	Class 2	870.1650	2007-12-06
DXT	Injector And Syringe, Angiographic	Cardiovascular	Class 2	870.1650	1992-08-20
FRN	Pump, Infusion	General Hospital	Class 2	880.5725	2008-06-20
DXT	Injector And Syringe, Angiographic	Cardiovascular	Class 2	870.1650	2011-11-10
DXT	Injector And Syringe, Angiographic	Cardiovascular	Class 2	870.1650	2011-05-19
LHI	Set, I.V. Fluid Transfer	General Hospital	Class 2	880.5440	2003-08-19
FPK	Tubing, Fluid Delivery	General Hospital	Class 2	880.5440	2003-08-19

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
3004056159	Bayer Medical Care Inc.	Pittsburgh, PA, US

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K221518	Np Medical	NP Medical nCompass Extension Set with Stabilizing Base	2022-11-03
K953474	Medikmark, Inc.	IV START KIT	1995-10-02
K972493	Nipro Medical Corp.	NIPRO DISPOSABLE SOLUTION INFUSION SET	1997-09-18
K982672	Baxter Healthcare Corp	COLLEAGUE PUMP SYRINGE ADAPTER SET	1998-09-04
K143446	Roche Diagnostics GmbH	Accu-Chek FlexLink Plus infusion set	2015-08-13

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)
Z-0010-2025	Smiths Medical ASD Inc.	2	CADD Medication Cassette Reservoir, 100mL, Product Code 21-7002-24
Z-0011-2025	Smiths Medical ASD Inc.	2	CADD Medication Cassette Reservoir, 100mL, FS, Product Code 21-7302-24
Z-0012-2013	Baxter Healthcare Corp. Rt.	2	Baxter Interlink System Buretrol Solution Set with 150 mL Burette (Ball-Valve Drip Chamber); a sterile Rx IV fluid pathway device. Product Usage: The device is used for the administration of fluids from a container into the patient's vascular system through a vascular access device.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 2520313. Last updated year: 2026. Please use registration number 2520313 when referencing this establishment in official correspondence.