FDA device listing
Breathing circuit set, coaxial, single use, adult/pediatric PN 260094, PN 260127, PN 260128, PN 260184, PN…
FDA device listing 1594369810 · INT'AIR MEDICAL
Key facts
| Proprietary names | Breathing circuit set, coaxial, single use, adult/pediatric PN 260094, PN 260127, PN 260128, PN 260184, PN 260206,Breathing circuit set, coaxial, single use, adult/pediatric PN 260167, PN 260168, PN 260145, PN 260144, PN 260087,Breathing circuit set, coaxial, single use, adult/pediatric PN 260207, PN 260239, PN 260240, PN 260257,Breathing circuit sets, dual limb, single use, neonatal/pediatric PN… |
|---|---|
| Owner/operator | INT'AIR MEDICAL |
| Owner/operator number | 10091244 |
| Product codes | BZO |
| Device names | BZO - Set, Tubing And Support, Ventilator (W Harness) |
| Device class | Class I |
| Classification regulations (21 CFR) | 868.5975 |
| Review panels | Anesthesiology |
| Registered establishments | INT'AIR MEDICAL |
| Establishment registrations | 3030149975 |
| FEI numbers | 3030149975 |
| Establishment operations | Foreign Exporter |
| 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