FDA device listing
Hudson RCI High Concentration Oxygen Mask,Medline Hudson RCI Face Tent,Medline Hudson RCI High-Concentration Oxygen…
FDA device listing 1961087222 · Medline Industries, LP
Key facts
| Proprietary names | Hudson RCI High Concentration Oxygen Mask,Medline Hudson RCI Face Tent,Medline Hudson RCI High-Concentration Oxygen Masks,Medline Oxygen Mask,Medline Tracheostomy Mask |
|---|---|
| Owner/operator | Medline Industries, LP |
| Owner/operator number | 1417592 |
| Product codes | BYG |
| Device names | BYG - Mask, Oxygen |
| Device class | Class I |
| Classification regulations (21 CFR) | 868.5580 |
| Review panels | Anesthesiology |
| Registered establishments | MEDLINE INDUSTRIES, LP - Northfield, Medline International B.V., RCI HUDSON DE MEXICO S. DE RL. DE CV. |
| Establishment registrations | 1417592, 3014499739, 3029706818 |
| FEI numbers | 1417592, 3014499739, 3029706818 |
| Establishment operations | Foreign Exporter, Manufacturer, Specification Developer |
| Registration valid through | 2026 |
At a glance
- 1–9 Registered establishments listing this device
- None listed 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