FDA Registration
Active
🇺🇸 United States
Elite Multiport Venous Femoral Catheter, 28 Fr.
Reg #: 2011171
·
FEI: 2011171
·
Expires 2025
Products
1
Proprietary Names
5
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- Sterigenics US LLC
- Registration Number
- 2011171
- FEI Number
- 2011171
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 4900 Gifford Ave
- City
- Los Angeles
- State
- CA
- ZIP
- 90058
- Country
- US
Regulatory Submissions
- 510(k) Number
- K081933
Owner / Operator
- Firm Name
- Sotera Health LLC
- Operator Number
- 10029425
- Address
- 2015 Spring Road, Suite 650
- City
- Oak Brook
- State
- IL
- Postal Code
- 60523
- Country
- US
- Correspondent
- Karen Whaley-Krumins
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass | DWF | Class 2 | Cardiovascular | No | 2012-12-04 |
Proprietary Names
Elite Multiport Venous Femoral Catheter, 28 Fr.
Elite Multiport Venous Femoral Catheter, 24 Fr.
Elite Multiport Venous Femoral Catheter, 22 Fr.
Elite Multiport Venous Femoral Catheter, 20 Fr.
Elite Multiport Venous Femoral Catheter, 26 Fr.
Establishment Types
Sterilize Medical Device for Another Party (Contract Sterilizer)