# Mfg One, LLC (contract manufacturer, Chantilly, VA): 6 new FDA device listings, incl. warmer, thermal, infusion fluid

**Score:** 80/100

| Field | Value |
|---|---|
| Establishment | Mfg One, LLC |
| Role | Contract manufacturer |
| Establishment types | Manufacture Medical Device for Another Party (Contract Manufacturer) |
| Location | Chantilly, VA, US |
| New listings | 6 |
| Devices | Warmer, Thermal, Infusion Fluid; Set, Administration, Intravascular; Pump, Infusion |
| Product codes | LGZ, FPA, FRN |
| Device classes | Class II |
| Medical specialties | General Hospital |
| Brand names | ThermaCor 1200; TIS 1200; ThermaCor |
| First new listing | 2026-07-09 |
| Latest new listing | 2026-07-09 |
| FDA registration number | 3004167615 |
| Registration expires | 2027-12-31 |

## Why this score
- Contract manufacturer or sterilizer adding work.
- Class II or III devices: QMS and regulatory demands.
- Several new listings at once.
- U.S. establishment.

Source: openFDA device registration and listing endpoint (U.S. Food and Drug Administration) (https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRL/rl.cfm). Last refreshed: 2026-11-04T21:52:36.524Z.
From the openFDA device registration and listing data, refreshed weekly. A listing shows a device an establishment says it makes or handles for the U.S. market; it is not FDA clearance or approval. Contact persons and street addresses are not stored. Verify in the FDA Establishment Registration and Device Listing database.