FDA device listing
LungFit® PH,LungFit® PH Bagging Kit (90005),LungFit® PH NDM Assembly (90014),LungFit® PH NO2 Filter (90008),LungFit® PH…
FDA device listing 1578460149 · Spartronics Watertown LLC
Key facts
| Proprietary names | LungFit® PH,LungFit® PH Bagging Kit (90005),LungFit® PH NDM Assembly (90014),LungFit® PH NO2 Filter (90008),LungFit® PH Verification Kit (90015) |
|---|---|
| Owner/operator | Spartronics Watertown LLC |
| Owner/operator number | 10045726 |
| Product codes | QTB |
| Device names | QTB - Nitric Oxide Generator And Delivery System |
| Device class | Class III |
| Classification regulations (21 CFR) | ORCA1.QTB |
| Review panels | Anesthesiology |
| Registered establishments | Spartronics Watertown LLC |
| Establishment registrations | 2133772 |
| FEI numbers | 3000209794 |
| 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