FDA device listing
BriteBlade Pro,BritePro Omni,BritePro Solo,ProVu Lite,ProVu Video Laryngoscope
FDA device listing 1184509634 · FLEXICARE MEDICAL LTD.
Key facts
| Proprietary names | BriteBlade Pro,BritePro Omni,BritePro Solo,ProVu Lite,ProVu Video Laryngoscope |
|---|---|
| Owner/operator | FLEXICARE MEDICAL LTD. |
| Owner/operator number | 8021995 |
| Product codes | CCW |
| Device names | CCW - Laryngoscope, Rigid |
| Device class | Class I |
| Classification regulations (21 CFR) | 868.5540 |
| 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