FDA device listing
iOTM Mini Nasal Mask (Ivolve Nasal Mask, Ivolve Full Face Mask, Ivolve N2),Siesta full face mask; Siesta nasal mask…
FDA device listing 1735588750 · React Health
Key facts
| Proprietary names | iOTM Mini Nasal Mask (Ivolve Nasal Mask, Ivolve Full Face Mask, Ivolve N2),Siesta full face mask; Siesta nasal mask (F5A; N5B) |
|---|---|
| Owner/operator | React Health |
| Owner/operator number | 10040143 |
| Premarket submissions | K131901 |
| 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 | 3B Medical Inc, 3B MEDICAL INC |
| Establishment registrations | 3009096682, 3042507287 |
| FEI numbers | 3009096682, 3042507287 |
| Establishment operations | Complaint File Establishment, Manufacturer |
| Registration valid through | 2026 |
At a glance
- 1–9 Registered establishments listing this device
- 1–9 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