FDA device listing
FLEXICARE MOUTHPIECE,ONE WAY VALVE EXP(200),ONE WAY VALVE:EXP (5X20),ONE WAY VALVE INSP (200),ONE WAY VALVE INSP…
FDA device listing 1947512782 · FLEXICARE MEDICAL LTD.
Key facts
| Proprietary names | FLEXICARE MOUTHPIECE,ONE WAY VALVE EXP(200),ONE WAY VALVE:EXP (5X20),ONE WAY VALVE INSP (200),ONE WAY VALVE INSP (500),ONE WAY VALVE:INSP (5X20) |
|---|---|
| Owner/operator | FLEXICARE MEDICAL LTD. |
| Owner/operator number | 8021995 |
| Product codes | BYP |
| Device names | BYP - Mouthpiece, Breathing |
| Device class | Class I |
| Classification regulations (21 CFR) | 868.5620 |
| Review panels | Anesthesiology |
| Registered establishments | CLEMENT CLARKE INTL., LTD., Flexicare Lanka (Pvt) Ltd, FLEXICARE MEDICAL (DONGGUAN) LTD., FLEXICARE MEDICAL LTD. |
| Establishment registrations | 8021995, 9610639, 3006061749, 3017202422 |
| FEI numbers | 3002806708, 3006061749, 3006363476, 3017202422 |
| Establishment operations | Contract Manufacturer, 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