Endotracheal Tube labeled as the following: a. Endotracheal Tube oral/nasal Magill, High Volume, Low Pressure Cuff; b. Endotracheal Tube oral/nasal Murphy Eye, High Volume, Low Pressure Cuff; c. Flexiset Super Safety Clear Tracheal Tube, oral/nasal with Cuff and Insertion Aid; d. RUSCHELIT Safety Clear Tracheal Tube, oral/nasal, Magill; e. RUSCHELIT Safety Clear Tracheal Tube, oral/nasal, Murphy. Intended for patients requiring endotracheal intubation
Potential for pilot balloon non-inflation or cuff non-deflation.
Worldwide - US Nationwide distribution including in the states of AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, IL, IN, KS, LA, MA, MD, MI, MN, MO, MS, NC, ND, NJ, NV, NY, OH, OK, PA, SC, SD, TX, UT, VA, WA, WI, WV and PR. The countries of Albania, Armenia, Austria, Azerbaijan, Bahamas, Barbados, Belgium, Brazil, Bulgaria, Burkina Faso, Canada, Chile, China, Croatia, Cyprus, Czech, Denmark, El Salvador, Estonia, Finland, France, French Guiana, French Polynesia, Germany, Great Britain, Greece, Hong Kong, Hungary, Iceland, Ireland, Italy Israel, Jordan, Kuwait, Lebanon, Liechtenstein, Malaysia, Mayotte, Mexico, Moldova, Morocco, Nepal, Netherlands, Norway, Panama, Philippines, Poland, Portugal, R¿union, Russia, San Marino, Saudi Arabia, Serbia, Singapore, Slovakia, Slovenia, Spain, South Africa, South Korea, Sweden, Switzerland, Taiwan Thailand, Turkey, Ukraine, United Arab Emirates.
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1012-2023