FDA device listing
JEM 325 Endotracheal Tube Changer,JEM 330 Endotracheal Tube Changer,JEM 340 Endotracheal Tube Changer,JEM 350…
FDA device listing 1281556463 · INSTRUMENTATION INDUSTRIES, INCORPORATED
Key facts
| Proprietary names | JEM 325 Endotracheal Tube Changer,JEM 330 Endotracheal Tube Changer,JEM 340 Endotracheal Tube Changer,JEM 350 Endotracheal Tube Changer,JEM 355 Endotracheal Tube Changer,JEM 360 Endotracheal Tube Changer,JEM 365 Endotracheal Tube Changer,JEM 370 Endotracheal Tube Changer,JEM 400 Endotracheal Tube Changer,JEM 401 Set of 9 Endotracheal Tube Changers |
|---|---|
| Owner/operator | INSTRUMENTATION INDUSTRIES, INCORPORATED |
| Owner/operator number | 2518436 |
| Premarket submissions | P800068 |
| Product codes | LNZ |
| Device names | LNZ - Changer, Tube, Endotracheal |
| Device class | Class II |
| Classification regulations (21 CFR) | 868.5730 |
| Review panels | Anesthesiology |
| Registered establishments | INSTRUMENTATION INDUSTRIES, INCORPORATED |
| Establishment registrations | 2518436 |
| FEI numbers | 2518436 |
| Establishment operations | Manufacturer |
| Registration valid through | 2026 |
At a glance
- 1–9 Registered establishments listing this device
- None UDI devices (GUDID) under the same submission
- 1–9 Device listings citing the same submission
- Yes 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