FDA device listing
Platinum 5NXG Oxygen Concentrator
FDA device listing 1013550935 · KIMBALL SOLUTIONS GROUP, LLC
Key facts
| Proprietary names | Platinum 5NXG Oxygen Concentrator |
|---|---|
| Owner/operator | KIMBALL SOLUTIONS GROUP, LLC |
| Owner/operator number | 9071700 |
| Product codes | CAW |
| Device names | CAW - Generator, Oxygen, Portable |
| Device class | Class II |
| Classification regulations (21 CFR) | 868.5440 |
| Review panels | Anesthesiology |
| Registered establishments | Kimball Electronics - Mexico SA de CV |
| Establishment registrations | 3027241818 |
| FEI numbers | 3027241818 |
| 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