FDA device listing
Healthy Hose,Healthy Hose Pro,Series A CPAP Tubing, BreatheLight CPAP Tubing,,Series Ultra Blue CPAP Tubing,Series X…
FDA device listing 1616415353 · Romax Hose, Inc.
Key facts
| Proprietary names | Healthy Hose,Healthy Hose Pro,Series A CPAP Tubing, BreatheLight CPAP Tubing,,Series Ultra Blue CPAP Tubing,Series X CPAP Tubing, Series M CPAP Tubing, |
|---|---|
| Owner/operator | Romax Hose, Inc. |
| Owner/operator number | 10038330 |
| Product codes | BYX |
| Device names | BYX - Tubing, Pressure And Accessories |
| Device class | Class I |
| Classification regulations (21 CFR) | 868.5860 |
| Review panels | Anesthesiology |
| Registered establishments | ROMAX HOSE, INC. |
| Establishment registrations | 3009350878 |
| FEI numbers | 3009350878 |
| Establishment operations | Manufacturer |
| 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