FDA device listing
F2 Single-Patient Vented Full Face Mask (BMC-FM2) - (Device Modification) ((BMC-NM Nasal Mask, BMC-NM2 Nasal Mask,Numa…
FDA device listing 1247644754 · React Health
Key facts
| Proprietary names | F2 Single-Patient Vented Full Face Mask (BMC-FM2) - (Device Modification) ((BMC-NM Nasal Mask, BMC-NM2 Nasal Mask,Numa Full Face Mask (BMC-FM2) ((Viva Nasal Mask (Model: NM4), Numa Full Face Mask (Model: BMC-FM2)),Numa II Full Face Mask (F4) - (Device Modification) ((Viva Nasal Mask (Model: NM4), Numa Full Face Mask (Model: BMC-FM2),Viva Nasal Mask (Model: NM4) (Viva Nasal Mask (Model: NM4), Numa… |
|---|---|
| Owner/operator | React Health |
| Owner/operator number | 10040143 |
| Premarket submissions | K163464 |
| 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