FDA Registration Active 🇺🇸 United States

Bayer Medical Care Inc.

Reg #: 2520313 · FEI: 2520313 · Expires 2026
Products
15
Proprietary Names
115
Establishment Types
4
Classifications
15

Registration Details

Registration Name
Bayer Medical Care Inc.
Registration Number
2520313
FEI Number
2520313
Status
Active
Expiry Year
2026
Initial Importer
No
Address
1 Bayer Drive
City
INDIANOLA
State
PA
ZIP
15051
Country
US

Regulatory Submissions

510(k) Number
K935668

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
Set, Administration, Intravascular FPA
Cephalometer EAG
System, X-Ray, Tomography, Computed JAK
Tubing, Fluid Delivery FPK
Radioimmunoassay, Digoxin (3-H), Goat Antibody, 2nd Antibody Sep. DOY
Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms) MWI
Iodinated Contrast Media Transfer Tubing Set PQH
Tubing, Pump, Cardiopulmonary Bypass DWE
Injector, Contrast Medium, Automatic IZQ
Medical Device Data System OUG
System, Nuclear Magnetic Resonance Imaging LNH
Pump, Infusion FRN
Tape And Bandage, Adhesive KGX
Set, I.V. Fluid Transfer LHI

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) P3T Cardiac Connect.CT 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 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 for CT (CVTS) MEDRAD Centargo Patient Line MEDRAD Centargo CT Injection System 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 MEDRAD Intego Patient Administration Set MEDRAD Intego Source Administration Set MEDRAD Intego PET Infusion System 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) MEDRAD Imaging System Interface (ISI 700) Female Luer Transfer Set Stellant CT Injector System with P3T Cardiac Stellant CT Injector Systtem Swabbable Valve Transfer Set MEDRAD Imaging Bulk Package Transfer Spike 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 MRI Disposable Syringe Kit MRI Connector Tubing Medrad® PRES™ Pressure-Rated Extension Set Qwik-Fit Syringe 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 MEDRAD® Twist & Go Syringe Kit MEDRAD® VFlow Sterile Hand Controller MEDRAD® Mark 7 Arterion Injection System VFlow Software

Establishment Types

Manufacture Medical Device Complaint File Establishment per 21 CFR 820.198 Develop Specifications But Do Not Manufacture At This Facility Manufacture Device in the United States for Export Only