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 | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Injector And Syringe, Angiographic | DXT | Class 2 | Cardiovascular | No | 2016-12-09 |
| Set, Administration, Intravascular | FPA | Class 2 | General Hospital | No | 2013-07-30 |
| Cephalometer | EAG | Class 2 | Dental | No | 2008-12-16 |
| System, X-Ray, Tomography, Computed | JAK | Class 2 | Radiology | No | 2013-07-24 |
| Tubing, Fluid Delivery | FPK | Class 2 | General Hospital | No | 2014-01-21 |
| Radioimmunoassay, Digoxin (3-H), Goat Antibody, 2nd Antibody Sep. | DOY | Class 2 | Clinical Toxicology | No | 2014-08-13 |
| Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms) | MWI | Class 2 | Cardiovascular | No | 2009-12-15 |
| Iodinated Contrast Media Transfer Tubing Set | PQH | Class 2 | General Hospital | No | 2018-07-19 |
| Tubing, Pump, Cardiopulmonary Bypass | DWE | Class 2 | Cardiovascular | No | 2014-01-24 |
| Injector, Contrast Medium, Automatic | IZQ | Class 2 | Cardiovascular | No | 2007-12-06 |
| Medical Device Data System | OUG | Class 1 | General Hospital | No | 2011-04-18 |
| System, Nuclear Magnetic Resonance Imaging | LNH | Class 2 | Radiology | No | 2013-01-22 |
| Pump, Infusion | FRN | Class 2 | General Hospital | No | 2010-12-29 |
| Tape And Bandage, Adhesive | KGX | Class 1 | General Hospital | No | 2016-09-13 |
| Set, I.V. Fluid Transfer | LHI | Class 2 | General Hospital | No | 2003-08-19 |
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