FDA Registration
Active
🇺🇸 United States
MFG ONE, LLC
Reg #: 3004167615
·
FEI: 3004167615
·
Expires 2026
Products
5
Proprietary Names
21
Establishment Types
1
Classifications
4
Registration Details
- Registration Name
- MFG ONE, LLC
- Registration Number
- 3004167615
- FEI Number
- 3004167615
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 14851 Stonecroft Center Ct
- City
- CHANTILLY
- State
- VA
- ZIP
- 20151
- Country
- US
Owner / Operator
- Firm Name
- MFG ONE, LLC
- Operator Number
- 9058759
- Address
- 3900 SKYHAWK DR., --
- City
- Chantilly
- State
- VA
- Postal Code
- 20151
- Country
- US
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Warmer, Thermal, Infusion Fluid | LGZ | Class 2 | General Hospital | No | 2007-12-14 |
| LDQ | No | 2005-12-01 | |||
| Pump, Air, Non-Manual, For Endoscope | FEQ | Class 2 | Gastroenterology, Urology | No | 2025-12-15 |
| Endoscopic Irrigation/Suction System | OCX | Class 2 | Gastroenterology, Urology | No | 2025-12-15 |
| Warmer, Irrigation Solution | LHC | Class 1 | Physical Medicine | No | 2020-09-17 |
Proprietary Names
Temp 2 - 5000 Series
Temp 2 - 6000 Series
Temp 2
8N1
16N1
HEAT STACK
T HOLD
OpClear System
IntraTemp Fluid Warming System
Hush - Slush
Irrigation Warmer - 2000 Series
IntraTemp Fluid Warming System - ITW6L
Smart Warmer
OpClear Platform (CU3 DI3)
Temp 3 - 5000
Temp 3 - 6000
Temp 3 - 7000
Temp 1 - 6000L
986S
986L
Temp 1 - 6000S
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)