FDA device listing
Amvex gas hoses,Flowmeter,Gas accessory block,Gas low pressure module,Gas supply module,Neopuff Supply Line-Long,Neopuff…
FDA device listing 1492921947 · FISHER & PAYKEL HEALTHCARE NZ LTD
Key facts
| Proprietary names | Amvex gas hoses,Flowmeter,Gas accessory block,Gas low pressure module,Gas supply module,Neopuff Supply Line-Long,Neopuff Supply Line-Short,Suction accessory block |
|---|---|
| Owner/operator | FISHER & PAYKEL HEALTHCARE NZ LTD |
| Owner/operator number | 8040217 |
| Product codes | BYX |
| Device names | BYX - Tubing, Pressure And Accessories |
| Device class | Class I |
| Classification regulations (21 CFR) | 868.5860 |
| Review panels | Anesthesiology |
| Registered establishments | FISHER & PAYKEL HEALTHCARE, INC., FISHER & PAYKEL HEALTHCARE, LTD. |
| Establishment registrations | 2085602, 9611451 |
| FEI numbers | 3000210616, 3002806988 |
| Establishment operations | Complaint File Establishment, 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