FDA device listing
Performax, FitLife EE Total Face Mask
FDA device listing 1910378542 · Philips Medical Systems International BV
Key facts
| Proprietary names | Performax, FitLife EE Total Face Mask |
|---|---|
| Owner/operator | Philips Medical Systems International BV |
| Owner/operator number | 2518422 |
| Premarket submissions | K091271 |
| 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 | Respironics Deutschland GmbH & Co.KG, RESPIRONICS INC. |
| Establishment registrations | 2518422, 3001400310 |
| FEI numbers | 2518422, 3001400310 |
| Establishment operations | Complaint File Establishment, Specification Developer, Foreign Exporter |
| Registration valid through | 2026 |
At a glance
- 1–9 Registered establishments listing this device
- None 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