FDA device listing
NEBULIZER,,Nebulizer Mask Kit,Oxygen Mask
FDA device listing 1896949182 · Hangzhou Fushan Medical Appliance Co., Ltd.
Key facts
| Proprietary names | NEBULIZER,,Nebulizer Mask Kit,Oxygen Mask |
|---|---|
| Owner/operator | Hangzhou Fushan Medical Appliance Co., Ltd. |
| Owner/operator number | 10022911 |
| Product codes | BYG |
| Device names | BYG - Mask, Oxygen |
| Device class | Class I |
| Classification regulations (21 CFR) | 868.5580 |
| Review panels | Anesthesiology |
| Registered establishments | Hangzhou Fushan Medical Appliance Co., Ltd. |
| Establishment registrations | 3006787036 |
| FEI numbers | 3006787036 |
| Establishment operations | Contract Manufacturer, Contract Sterilizer, Manufacturer, Repackager/Relabeler |
| 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