FDA Registration
Active
🇺🇸 United States
Temp 1 - 6000L
Reg #: 3004167615
·
FEI: 3004167615
·
Expires 2025
Products
2
Proprietary Names
4
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- MFG ONE, LLC
- Registration Number
- 3004167615
- FEI Number
- 3004167615
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 14851 Stonecroft Center Ct
- City
- CHANTILLY
- State
- VA
- ZIP
- 20151
- Country
- US
Regulatory Submissions
- 510(k) Number
- K981509
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 | 2007-12-14 |
Proprietary Names
Temp 1 - 6000L
986S
986L
Temp 1 - 6000S
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)