FDA Registration
Active
🇺🇸 United States
NOVOSCI CORP.
Reg #: 1625519
·
FEI: 1625519
·
Expires 2026
Products
11
Proprietary Names
10
Establishment Types
3
Classifications
11
Registration Details
- Registration Name
- NOVOSCI CORP.
- Registration Number
- 1625519
- FEI Number
- 1625519
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- Yes
- Address
- 2021 Airport Road
- City
- Conroe
- State
- TX
- ZIP
- 77301
- Country
- US
Regulatory Submissions
- 510(k) Number
- K801400
Owner / Operator
- Firm Name
- NOVOSCI CORP.
- Operator Number
- 9057741
- Address
- 2021 Airport Road, --
- City
- Conroe
- State
- TX
- Postal Code
- 77301
- Country
- US
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Sucker, Cardiotomy Return, Cardiopulmonary Bypass | DTS | Class 2 | Cardiovascular | No | 2000-01-27 |
| Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass | DWF | Class 2 | Cardiovascular | No | 2011-12-02 |
| Filter, Blood, Cardiopulmonary Bypass, Arterial Line | DTM | Class 2 | Cardiovascular | No | 2000-01-27 |
| Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass | DTL | Class 2 | Cardiovascular | No | 2000-01-27 |
| Accessory Equipment, Cardiopulmonary Bypass | KRI | Class 1 | Cardiovascular | No | 2000-01-27 |
| Instruments, Surgical, Cardiovascular | DWS | Class 1 | Cardiovascular | No | 2000-01-27 |
| Accessories, Blood Circuit, Hemodialysis | KOC | Class 2 | Gastroenterology, Urology | No | 2011-11-29 |
| Defoamer, Cardiopulmonary Bypass | DTP | Class 2 | Cardiovascular | No | 2011-12-02 |
| Reservoir, Blood, Cardiopulmonary Bypass | DTN | Class 2 | Cardiovascular | No | 2011-12-02 |
| Clamp, Vascular | DXC | Class 2 | Cardiovascular | No | 2000-01-27 |
| Oxygenator, Cardiopulmonary Bypass | DTZ | Class 2 | Cardiovascular | No | 2011-12-02 |
Proprietary Names
CARDIOPULMONARY BYPASS CARDIOTOMY RETURN SUCKER
CARDIOPULMONARY BYPASS CATHETER, CANNULA AND VASCULAR TUBING
CARDIOPULMONARY BYPASS ARTERIAL LINE BLOOD FILTER
CARDIOPULMONARY BYPASS ADAPTOR, STOPCOCK AND MANIFOLD FITTING
CARDIOPULMONARY BYPASS ACCESSORY EQUIPMENT
CARDIOVASCULAR SURGICAL INSTRUMENTS
HEMODIALYSIS BLOOD CIRCUIT ACCESSORIES
CARDIOPULMONARY BYPASS BLOOD RESERVOIR
VASCULAR CLAMP
CARDIOPULMONARY BYPASS OXYGENATOR (stopcock accessory)
Establishment Types
Develop Specifications But Do Not Manufacture At This Facility
Manufacture Medical Device
Repack or Relabel Medical Device