FDA Registration
Active
🇺🇸 United States
Z1
Reg #: 3010817335
·
FEI: 3010817335
·
Expires 2025
Products
1
Proprietary Names
1
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- BREAS MEDICAL, INC.
- Registration Number
- 3010817335
- FEI Number
- 3010817335
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- Yes
- Address
- 16 Esquire Road
- City
- N Billerica
- State
- MA
- ZIP
- 01862
- Country
- US
Regulatory Submissions
- 510(k) Number
- K121374
Owner / Operator
- Firm Name
- BREAS MEDICAL, INC.
- Operator Number
- 10046641
- Address
- 16 Esquire Road
- City
- N Billerica
- State
- MA
- Postal Code
- 01862
- Country
- US
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Ventilator, Non-Continuous (Respirator) | BZD | Class 2 | Anesthesiology | No | 2014-04-21 |
Proprietary Names
Z1
Establishment Types
Manufacture Medical Device