FDA Registration
Active
🇺🇸 United States
OXY-1 System
Reg #: 3014990448
·
FEI: 3014990448
·
Expires 2025
Products
4
Proprietary Names
1
Establishment Types
1
Classifications
4
Registration Details
- Registration Name
- Breethe, Inc.
- Registration Number
- 3014990448
- FEI Number
- 3014990448
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 1500 Joh Ave, #190
- City
- Halethorpe
- State
- MD
- ZIP
- 21227
- Country
- US
Regulatory Submissions
- 510(k) Number
- K223161
Owner / Operator
- Firm Name
- ABIOMED, INC.
- Operator Number
- 1220648
- Address
- 22 CHERRY HILL DR., --
- City
- Danvers
- State
- MA
- Postal Code
- 01923
- Country
- US
- Correspondent
- Anshul Shah
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Control, Pump Speed, Cardiopulmonary Bypass | DWA | Class 2 | Cardiovascular | No | 2023-04-20 |
| Oxygenator, Cardiopulmonary Bypass | DTZ | Class 2 | Cardiovascular | No | 2023-04-20 |
| Pump, Blood, Cardiopulmonary Bypass, Non-Roller Type | KFM | Class 2 | Cardiovascular | No | 2023-04-20 |
| Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass | DWF | Class 2 | Cardiovascular | No | 2023-04-20 |
Proprietary Names
OXY-1 System
Establishment Types
Manufacture Medical Device