FDA Registration
Active
🇺🇸 United States
CO2 Insufflator
Reg #: 3003174284
·
FEI: 3003174284
·
Expires 2025
Products
1
Proprietary Names
1
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- NextPhase Medical Devices, LLC
- Registration Number
- 3003174284
- FEI Number
- 3003174284
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 110 FORBES BLVD.
- City
- MANSFIELD
- State
- MA
- ZIP
- 02048
- Country
- US
Regulatory Submissions
- 510(k) Number
- K162332
Owner / Operator
- Firm Name
- NextPhase Medical Devices, LLC
- Operator Number
- 9050650
- Address
- 110 FORBES BLVD., --
- City
- Mansfield
- State
- MA
- Postal Code
- 02048
- Country
- US
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Insufflator, Automatic Carbon-Dioxide For Endoscope | FCX | Class 2 | Gastroenterology, Urology | No | 2023-03-15 |
Proprietary Names
CO2 Insufflator
Establishment Types
Manufacture Medical Device