FDA device listing
FLEXICARE AEROSOL MASKS,FLEXICARE CPAP MASK HEAD STRAP,FLEXICARE FIRST AID MASK,VENTICAIRE MEDIUM CONCENTRATION MASKS
FDA device listing 1980468638 · FLEXICARE MEDICAL LTD.
Key facts
| Proprietary names | FLEXICARE AEROSOL MASKS,FLEXICARE CPAP MASK HEAD STRAP,FLEXICARE FIRST AID MASK,VENTICAIRE MEDIUM CONCENTRATION MASKS |
|---|---|
| Owner/operator | FLEXICARE MEDICAL LTD. |
| Owner/operator number | 8021995 |
| Product codes | BYG |
| Device names | BYG - Mask, Oxygen |
| Device class | Class I |
| Classification regulations (21 CFR) | 868.5580 |
| 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