FDA Registration
Active
🇲🇽 Mexico
Affinity Temperature Probe
Reg #: 9617601
·
FEI: 3002534070
·
Expires 2025
Products
6
Proprietary Names
5
Establishment Types
1
Classifications
6
Registration Details
- Registration Name
- Medtronic Mexico S. de R.L. de CV
- Registration Number
- 9617601
- FEI Number
- 3002534070
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- Av. Paseo Cucapah 10510 El Lago
- City
- Tijuana Baja California
- Country
- MX
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
US Agent
- Business Name
- Medtronic
- Contact Name
- Celia Encinas
- Address
- 1610 Landmark Rd
- City
- San Diego
- State
- CA
- ZIP
- 92154
- Country
- US
- [email protected]
- Phone
- 949 7983913
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