FDA device listing
Vitera Mask Dbl Seal Lrg/Lrg A Model,Vitera Mask Dbl Seal Med/Med A Model,Vitera Mask Dbl Seal Sml/Sml A Model,Vitera…
FDA device listing 1291518033 · FISHER & PAYKEL HEALTHCARE NZ LTD
Key facts
| Proprietary names | Vitera Mask Dbl Seal Lrg/Lrg A Model,Vitera Mask Dbl Seal Med/Med A Model,Vitera Mask Dbl Seal Sml/Sml A Model,Vitera Mask Fitpack Sml/Med/Lrg A Model,Vitera Mask Full Face Large A Model,Vitera Mask Full Face Large Sleep Lab,Vitera Mask Full Face Medium A Model,Vitera Mask Full Face Medium Sleep Lab,Vitera Mask Full Face Med/Lrg Sleep Lab,Vitera Mask Full Face Small A Model,Vitera Mask Full Face… |
|---|---|
| Owner/operator | FISHER & PAYKEL HEALTHCARE NZ LTD |
| Owner/operator number | 8040217 |
| Premarket submissions | K190713 |
| 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
- 10–99 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