FDA Registration
Active
🇺🇸 United States
Affinity Temperature Probe
Reg #: 2184009
·
FEI: 1000116158
·
Expires 2025
Products
6
Proprietary Names
5
Establishment Types
1
Classifications
6
Registration Details
- Registration Name
- MEDTRONIC PERFUSION SYSTEMS
- Registration Number
- 2184009
- FEI Number
- 1000116158
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 7611 Northland Dr
- City
- Minneapolis
- State
- MN
- ZIP
- 55428
- Country
- US
Regulatory Submissions
- 510(k) Number
- K100645
Owner / Operator
- Firm Name
- Medtronic, Inc.
- Operator Number
- 2112641
- Address
- 710 Medtronic Parkway
- City
- Minneapolis
- State
- MN
- Postal Code
- 55432
- Country
- US
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Oxygenator, Cardiopulmonary Bypass | DTZ | Class 2 | Cardiovascular | No | 2012-09-21 |
| Filter, Blood, Cardiotomy Suction Line, Cardiopulmonary Bypass | JOD | Class 2 | Cardiovascular | No | 2012-09-21 |
| Defoamer, Cardiopulmonary Bypass | DTP | Class 2 | Cardiovascular | No | 2012-09-21 |
| Reservoir, Blood, Cardiopulmonary Bypass | DTN | Class 2 | Cardiovascular | No | 2012-09-21 |
| Heat-Exchanger, Cardiopulmonary Bypass | DTR | Class 2 | Cardiovascular | No | 2012-09-21 |
| Continuous Measurement Thermometer | FLL | Class 2 | General Hospital | No | 2012-09-21 |
Proprietary Names
Affinity Temperature Probe
Pixie Oxygenator, Carmeda coated
Pixie Oxygenation and CVR Combo, Carmeda coated
Pixie Oxygenator, Balance coated
Pixie Oxygenation and CVR Combo, Balance coated
Establishment Types
Manufacture Medical Device