FDA device listing
400470A Forma Full Face Mask,400470SL Forma Full Face Mask,400471A Forma Full Face Mask,400471SL Forma Full Face…
FDA device listing 2036346774 · FISHER & PAYKEL HEALTHCARE NZ LTD
Key facts
| Proprietary names | 400470A Forma Full Face Mask,400470SL Forma Full Face Mask,400471A Forma Full Face Mask,400471SL Forma Full Face Mask,400473A Forma Full Face Mask,400473SL Forma Full Face Mask,HC432 Flexifit Full Face Mask |
|---|---|
| Owner/operator | FISHER & PAYKEL HEALTHCARE NZ LTD |
| Owner/operator number | 8040217 |
| Premarket submissions | K061236 |
| 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, 3008264065 |
| FEI numbers | 3000210616, 3002806988, 3008264065 |
| Establishment operations | Complaint File Establishment, Manufacturer, Contract Manufacturer |
| 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