FDA Registration
Active
🇺🇸 United States
MPS Backup System (MPBUS)
Reg #: 1649914
·
FEI: 3001665800
·
Expires 2025
Products
5
Proprietary Names
1
Establishment Types
1
Classifications
5
Registration Details
- Registration Name
- QUEST MEDICAL, INC.
- Registration Number
- 1649914
- FEI Number
- 3001665800
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 1 Allentown Pkwy
- City
- ALLEN
- State
- TX
- ZIP
- 75002
- Country
- US
Regulatory Submissions
- 510(k) Number
- K002366
Owner / Operator
- Firm Name
- ATRION CORP.
- Operator Number
- 9914015
- Address
- ONE ALLENTOWN PKWY., --
- City
- Allen
- State
- TX
- Postal Code
- 75002
- Country
- US
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Detector, Bubble, Cardiopulmonary Bypass | KRL | Class 2 | Cardiovascular | No | 2009-06-30 |
| Gauge, Pressure, Coronary, Cardiopulmonary Bypass | DXS | Class 2 | Cardiovascular | No | 2009-06-30 |
| Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass | DWF | Class 2 | Cardiovascular | No | 2009-06-30 |
| Heat-Exchanger, Cardiopulmonary Bypass | DTR | Class 2 | Cardiovascular | No | 2009-06-30 |
| Transducer, Blood-Pressure, Extravascular | DRS | Class 2 | Cardiovascular | No | 2009-06-30 |
Proprietary Names
MPS Backup System (MPBUS)
Establishment Types
Manufacture Medical Device