FDA device listing
Bulb Irrigation Syringe 60cc; Ear Bulb Syringe; Enteral Irrigation Syringe 60cc; Flat Top Piston Irrigation Syringe…
FDA device listing 1939257239 · BOEN HEALTHCARE CO., LTD.
Key facts
| Proprietary names | Bulb Irrigation Syringe 60cc; Ear Bulb Syringe; Enteral Irrigation Syringe 60cc; Flat Top Piston Irrigation Syringe 60cc,Bulb Irrigation Syringe; Ear/Ulcer Syringe; Enteral Feeding Syringe; Enteral Irrigation Kit; Irrigation Kit,Irrigation Tray; Piston Enteral Irrigation Syringe 60cc; Thumb Control Piston Irrigation Syringe 60cc,Irrigation Tray; Piston Irrigation Tray; Pole Syringe; Vaginal… |
|---|---|
| Owner/operator | BOEN HEALTHCARE CO., LTD. |
| Owner/operator number | 10095691 |
| Product codes | KYZ |
| Device names | KYZ - Syringe, Irrigating (Non Dental) |
| Device class | Class I |
| Classification regulations (21 CFR) | 880.6960 |
| Review panels | General Hospital |
| Registered establishments | BOEN HEALTHCARE CO., LTD. |
| Establishment registrations | 3045058049 |
| FEI numbers | 3045058049 |
| Establishment operations | Foreign Exporter |
| 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