FDA Registration
Active
🇺🇸 United States
Manifolds
Reg #: 3007138831
·
FEI: 3007138831
·
Expires 2025
Products
1
Proprietary Names
1
Establishment Types
2
Classifications
1
Registration Details
- Registration Name
- ALLWELL MEDICAL CORPORATION
- Registration Number
- 3007138831
- FEI Number
- 3007138831
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 7424 Chapel Hill Rd 204
- City
- Raleigh
- State
- NC
- ZIP
- 27607
- Country
- US
Regulatory Submissions
- 510(k) Number
- K915301
Owner / Operator
- Firm Name
- Allwell Medical Corporation
- Operator Number
- 10024817
- Address
- 7424 Chapel Hill Rd 204
- City
- Raleigh
- State
- NC
- Postal Code
- 27607
- Country
- US
- Correspondent
- Jeff Wang
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass | DTL | Class 2 | Cardiovascular | No | 2009-02-16 |
Proprietary Names
Manifolds
Establishment Types
Repack or Relabel Medical Device
Develop Specifications But Do Not Manufacture At This Facility