FDA Registration
Active
🇺🇸 United States
Arterial Cannulae (EndoReturn)
Reg #: 3008998256
·
FEI: 3008998256
·
Expires 2025
Products
1
Proprietary Names
1
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- BIOMERICS
- Registration Number
- 3008998256
- FEI Number
- 3008998256
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 6030 W Harold Gatty Drive
- City
- Salt Lake City
- State
- UT
- ZIP
- 84116
- Country
- US
Regulatory Submissions
- 510(k) Number
- K971291
Owner / Operator
- Firm Name
- Biomerics
- Operator Number
- 10042380
- Address
- 6030 W Harold Gatty Drive
- City
- Salt Lake City
- State
- UT
- Postal Code
- 84116
- Country
- US
- Correspondent
- Jacob J Wakley
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass | DWF | Class 2 | Cardiovascular | No | 2020-11-20 |
Proprietary Names
Arterial Cannulae (EndoReturn)
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)