FDA device listing
Amvex Vacuum Regulator Digi/Analg,Amvex Venturi backpack suction,Paediatric analog vacuum,Paediatric digital…
FDA device listing 1783023772 · FISHER & PAYKEL HEALTHCARE NZ LTD
Key facts
| Proprietary names | Amvex Vacuum Regulator Digi/Analg,Amvex Venturi backpack suction,Paediatric analog vacuum,Paediatric digital vacuum,Venturi Backpack Suction Assembly |
|---|---|
| Owner/operator | FISHER & PAYKEL HEALTHCARE NZ LTD |
| Owner/operator number | 8040217 |
| Product codes | KDP |
| Device names | KDP - Regulator, Vacuum |
| Device class | Class II |
| Classification regulations (21 CFR) | 880.6740 |
| Review panels | General Hospital |
| Registered establishments | FISHER & PAYKEL HEALTHCARE, INC., FISHER & PAYKEL HEALTHCARE, LTD. |
| Establishment registrations | 2085602, 9611451 |
| FEI numbers | 3000210616, 3002806988 |
| Establishment operations | Complaint File Establishment, 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