FDA Registration
Active
🇺🇸 United States
COEUR, INC.(A WHOLLY OWNED SUBSIDIARY OF ILLINOIS TOOL WORKS INC.)
Reg #: 1038185
·
FEI: 1038185
·
Expires 2026
Products
5
Proprietary Names
4
Establishment Types
2
Classifications
5
Registration Details
- Registration Name
- COEUR, INC.(A WHOLLY OWNED SUBSIDIARY OF ILLINOIS TOOL WORKS INC.)
- Registration Number
- 1038185
- FEI Number
- 1038185
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 209 Creekside Dr
- City
- WASHINGTON
- State
- NC
- ZIP
- 27889
- Country
- US
Regulatory Submissions
- 510(k) Number
- K150902
Owner / Operator
- Firm Name
- Coeur, Inc. (a wholly owned subsidiary of Illinois Tool Work
- Operator Number
- 9038672
- Address
- 209 Creekside Drive
- City
- Washington
- State
- NC
- Postal Code
- 27889
- Country
- US
- Correspondent
- NEIL SPILLANE
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Iodinated Contrast Media Transfer Tubing Set | PQH | Class 2 | General Hospital | No | 2014-09-22 |
| Injector And Syringe, Angiographic | DXT | Class 2 | Cardiovascular | No | 2022-02-03 |
| Set, Administration, Intravascular | FPA | Class 2 | General Hospital | No | 2007-06-27 |
| Tubing, Fluid Delivery | FPK | Class 2 | General Hospital | No | 2007-06-27 |
| Injector, Contrast Medium, Automatic | IZQ | Class 2 | Cardiovascular | No | 2024-11-23 |
Proprietary Names
Disposable 330psi Extension line w/ dual check valve
Disposable 330psi Extension line
DISP. TRANSFER SETS W-WO SWAB
Low Pressure Injection Extension Tu
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)
Manufacture Medical Device