FDA device listing
ThermaCor,ThermaCor 1200,TIS 1200
FDA device listing 1798958275 · MFG ONE, LLC
Key facts
| Proprietary names | ThermaCor,ThermaCor 1200,TIS 1200 |
|---|---|
| Owner/operator | MFG ONE, LLC |
| Owner/operator number | 9058759 |
| Product codes | FPA, FRN, LGZ |
| Device names | FPA - Set, Administration, Intravascular, FRN - Pump, Infusion, LGZ - Warmer, Thermal, Infusion Fluid |
| Device class | Class II |
| Classification regulations (21 CFR) | 880.5440, 880.5725 |
| Review panels | General Hospital |
| Registered establishments | MFG ONE, LLC |
| Establishment registrations | 3004167615 |
| FEI numbers | 3004167615 |
| Establishment operations | Contract Manufacturer |
| Registration valid through | 2026 |
At a glance
- 1–9 Registered establishments listing this device
- None listed Premarket submission listed
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA device listings
Establishments that make or process devices for the U.S. market must list each device with the FDA. A listing records the device's proprietary names, product codes and premarket submission, and every registered establishment that handles it.
Source: U.S. Food and Drug Administration (FDA), Establishment Registration and Device Listing database