FDA device listing
Anesthesia breathing circuit kit (adult & pediatric),Circuits Anesthesia,Circuits Heated Wire,Humidifiers…
FDA device listing 1983107897 · SunMed Group Holdings, LLC dba AirLife
Key facts
| Proprietary names | Anesthesia breathing circuit kit (adult & pediatric),Circuits Anesthesia,Circuits Heated Wire,Humidifiers Heated,Nebulizers Large Volume Prefilled And Dry,O2 Delivery Adapters And Connectors,Resuscitation Bags Flow-Inflating,Westmed Breathing Circuits |
|---|---|
| Owner/operator | SunMed Group Holdings, LLC dba AirLife |
| Owner/operator number | 10044795 |
| Product codes | OFP |
| Device names | OFP - Anesthesia Breathing Circuit Kit (Adult & Pediatric) |
| Device class | Class I |
| Classification regulations (21 CFR) | 868.5240 |
| Review panels | Anesthesiology |
| Registered establishments | AirLife Finland Oy, PRODUCTOS UROLOGOS DE MEXICO S.A. DE C.V., SunMed Group Holdings, LLC |
| Establishment registrations | 1314417, 8030673, 3010838917 |
| FEI numbers | 1314417, 3004213967, 3010838917 |
| Establishment operations | Contract Manufacturer, 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