FDA device listing
68-PCHAT, Fast Respond Kit,989803150111, Fast Response Kit, FR3
FDA device listing 1103469003 · Philips Medical Systems International BV
Key facts
| Proprietary names | 68-PCHAT, Fast Respond Kit,989803150111, Fast Response Kit, FR3 |
|---|---|
| Owner/operator | Philips Medical Systems International BV |
| Owner/operator number | 1217116 |
| Product codes | KGB |
| Device names | KGB - Mask, Oxygen, Non-Rebreathing |
| Device class | Class I |
| Classification regulations (21 CFR) | 868.5570 |
| Review panels | Anesthesiology |
| Registered establishments | Philips Electronics Ltd, Philips North America LLC |
| Establishment registrations | 3030677, 3000126629, 3012607778 |
| FEI numbers | 1000524572, 3000126629, 3012607778 |
| Establishment operations | Foreign Exporter, Specification Developer |
| 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