FDA Registration Active 🇺🇸 United States

MEDRAD® Stellant FLEX Syringe Kits

Reg #: 3006791331 · FEI: 3006791331 · Expires 2025
Products
2
Proprietary Names
10
Establishment Types
1
Classifications
2

Registration Details

Registration Name
Bayer Medical Care Inc.
Registration Number
3006791331
FEI Number
3006791331
Status
Active
Expiry Year
2025
Initial Importer
No
Address
150 Victory Road
City
Saxonburg
State
PA
ZIP
16056
Country
US

Regulatory Submissions

510(k) Number
K173773

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, Contrast Medium, Automatic IZQ
Injector And Syringe, Angiographic DXT

Proprietary Names

MEDRAD® Stellant FLEX Syringe Kits MEDRAD® Stellant FLEX CT Injection System with Certegra Workstation P3T Cardiac MEDRAD® Stellant Syringe Kits MEDRAD® Stellant CT Injection System with Certegra Workstation P3T Abdomen P3T PA Connect.CT ISI MEDRAD® Stellant Connector Tubing

Establishment Types

Manufacture Medical Device