FDA device listing
HC482 Opus Nasal Pillows,Opus Nasal Pillows Mask
FDA device listing 1696576548 · FISHER & PAYKEL HEALTHCARE NZ LTD
Key facts
| Proprietary names | HC482 Opus Nasal Pillows,Opus Nasal Pillows Mask |
|---|---|
| Owner/operator | FISHER & PAYKEL HEALTHCARE NZ LTD |
| Owner/operator number | 8040217 |
| Premarket submissions | K063036 |
| Product codes | BZD |
| Device names | BZD - Ventilator, Non-Continuous (Respirator) |
| Device class | Class II |
| Classification regulations (21 CFR) | 868.5905 |
| Review panels | Anesthesiology |
| Registered establishments | FISHER & PAYKEL HEALTHCARE, INC., FISHER & PAYKEL HEALTHCARE, LTD., FISHER & PAYKEL HEALTHCARE S.A.DE C.V. |
| Establishment registrations | 2085602, 9611451, 3015928685 |
| FEI numbers | 3000210616, 3002806988, 3015928685 |
| Establishment operations | Complaint File Establishment, Manufacturer, Foreign Exporter |
| Registration valid through | 2026 |
At a glance
- 1–9 Registered establishments listing this device
- 1–9 UDI devices (GUDID) under the same submission
- 1–9 Device listings citing the same submission
- Yes 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