FDA device listing

Sheridan Close Fitting Endotracheal Tube,SHERIDAN EZ-ENDO Endotracheal Tube,Sheridan HVT Endotracheal Tube,Sheridan LTS…

FDA device listing 1505250223 · Teleflex

Key facts

Proprietary names Sheridan Close Fitting Endotracheal Tube,SHERIDAN EZ-ENDO Endotracheal Tube,Sheridan HVT Endotracheal Tube,Sheridan LTS Endotracheal Tube,Sheridan Naz-al Endotracheal Tube,SHERIDAN PED-SOFT UNCUFFED Endotracheal Tubes,SHERIDAN PREFORMED Endotracheal Tube,Sheridan Uncuffed Endotracheal Tube
Owner/operator Teleflex
Owner/operator number 9062981
Premarket submissions K822082
Product codes BTR
Device names BTR - Tube, Tracheal (W/Wo Connector)
Device class Class II
Classification regulations (21 CFR) 868.5730
Review panels Anesthesiology
Registered establishments Teleflex Medical de Tecate, S. de R.L de C.V., Teleflex Medical LLC
Establishment registrations 3003898360, 3011137372
FEI numbers 3003898360, 3005747797
Establishment operations Complaint File Establishment, Specification Developer, Manufacturer
Registration valid through 2026

At a glance

  • 1–9 Registered establishments listing this device
  • 100–999 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

Browse all FDA device listings