FDA Registration
Inactive
🇺🇸 United States
HEMANEXT INC.
·
Expires 2026
Products
1
Proprietary Names
1
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- HEMANEXT INC.
- Status
- Inactive
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 99 Hayden Ave., Building B Suite 620
- City
- Lexington
- State
- MA
- ZIP
- 02421
- Country
- US
Regulatory Submissions
- 510(k) Number
- BK251294
Owner / Operator
- Firm Name
- Hemanext Inc.
- Operator Number
- 10049356
- Address
- 99 Hayden Ave., Building B Suite 620
- City
- Lexington
- State
- MA
- Postal Code
- 02421
- Country
- US
- Correspondent
- Timothy S Burton
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Container System For The Processing And Storage Of Red Blood Cell Components Under Reduced Oxygen Conditions | QYC | Class 2 | Hematology | No | 2024-04-12 |
Proprietary Names
Hemanext ONE
Establishment Types
Develop Specifications But Do Not Manufacture At This Facility