FDA device listing
N95 respirator with antimicrobial/antiviral agent,SpectraShield
FDA device listing 1641228870 · Nexera Medical LLC
Key facts
| Proprietary names | N95 respirator with antimicrobial/antiviral agent,SpectraShield |
|---|---|
| Owner/operator | Nexera Medical LLC |
| Owner/operator number | 10093260 |
| Premarket submissions | K150729 |
| Product codes | ONT |
| Device names | ONT - N95 Respirator With Antimicrobial/Antiviral Agent |
| Device class | Class II |
| Classification regulations (21 CFR) | 878.4040 |
| Review panels | General & Plastic Surgery |
| Registered establishments | NEXERA MEDICAL LLC |
| Establishment registrations | 3037969189 |
| FEI numbers | 3037969189 |
| Establishment operations | Manufacturer |
| 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