FDA device listing
Airway Lifesaver Kit,Cath-Guide Guedel Airway,Dual Channel Airway,LMA Classic,LMA Classic Excel,LMA Cuff-Deflator,LMA…
FDA device listing 1007927144 · Teleflex
Key facts
| Proprietary names | Airway Lifesaver Kit,Cath-Guide Guedel Airway,Dual Channel Airway,LMA Classic,LMA Classic Excel,LMA Cuff-Deflator,LMA Fastrach,LMA Fastrach Stabiliser Rod,LMA Fastrach (SU),LMA Flexible,LMA Flexible PreCurved,LMA Flexible PreCurved Cuff Pilot,LMA Flexible (S),LMA Flexible (S) Cuff Pilot,LMA Flexible (SU),LMA Gastro Cuff Pilot,LMA NovaPlus,LMA ProSeal,LMA ProSeal Cuff Deflator,LMA ProSeal… |
|---|---|
| Owner/operator | Teleflex |
| Owner/operator number | 9062981 |
| Product codes | CAE |
| Device names | CAE - Airway, Oropharyngeal, Anesthesiology |
| Device class | Class I |
| Classification regulations (21 CFR) | 868.5110 |
| Review panels | Anesthesiology |
| Registered establishments | Teleflex Medical de Mexico, S. de R.L. de C.V., Teleflex Medical de Tecate, S. de R.L de C.V., Teleflex Medical LLC, The Laryngeal Mask Company (M) SDN. BHD. |
| Establishment registrations | 3003898360, 3004365956, 3009307931, 3011137372 |
| FEI numbers | 3003898360, 3004365956, 3005747797, 3009307931 |
| Establishment operations | Complaint File Establishment, Specification Developer, 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