FDA device listing
FLUIDSHIELD* 2 Fog-Free Procedure Mask with SO SOFT* Earloops, Blue, WrapAround Visor,FLUIDSHIELD* 2 Fog-Free Surgical…
FDA device listing 1795748406 · O&M Halyard, Inc.
Key facts
| Proprietary names | FLUIDSHIELD* 2 Fog-Free Procedure Mask with SO SOFT* Earloops, Blue, WrapAround Visor,FLUIDSHIELD* 2 Fog-Free Surgical Mask, Blue with Orange Print,FLUIDSHIELD* 2 Fog-Free Surgical Mask, Blue with Orange Print, WrapAround Visor,FLUIDSHIELD* 2 Procedure Mask with SO SOFT* Earloops,FLUIDSHIELD* 2 Procedure Mask with SO SOFT* Earloops, Blue,Fluidshield* 3 Fog-Free Procedure Mask with SO SOFT* Lining… |
|---|---|
| Owner/operator | O&M Halyard, Inc. |
| Owner/operator number | 10057479 |
| Premarket submissions | K111402 |
| Product codes | FXX |
| Device names | FXX - Mask, Surgical |
| Device class | Class II |
| Classification regulations (21 CFR) | 878.4040 |
| Review panels | General & Plastic Surgery |
| Registered establishments | La Ada de Acuna, O&M Halyard, Inc., O&M Halyard, Inc. (La Ada de Acuna) |
| Establishment registrations | 9616096, 3014421917, 3016849443 |
| FEI numbers | 3003807323, 3014421917, 3016849443 |
| Establishment operations | Complaint File Establishment, Manufacturer, Specification Developer |
| 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