FDA device listing
VENTICAIRE,VENTICAIRE VENTURI MASK,VENTIMASK VENTURI MASKS
FDA device listing 1505252205 · FLEXICARE MEDICAL LTD.
Key facts
| Proprietary names | VENTICAIRE,VENTICAIRE VENTURI MASK,VENTIMASK VENTURI MASKS |
|---|---|
| Owner/operator | FLEXICARE MEDICAL LTD. |
| Owner/operator number | 8021995 |
| Product codes | BYF |
| Device names | BYF - Mask, Oxygen, Low Concentration, Venturi |
| Device class | Class I |
| Classification regulations (21 CFR) | 868.5600 |
| Review panels | Anesthesiology |
| Registered establishments | Flexicare Lanka (Pvt) Ltd, FLEXICARE MEDICAL (DONGGUAN) LTD., FLEXICARE MEDICAL LTD. |
| Establishment registrations | 8021995, 3006061749, 3017202422 |
| FEI numbers | 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