Ventlab, LLC BreathTech manual resuscitators with integrated manometer, multiple accessory configurations to include: 1. BreathTech Adult Resuscitator REF #s: BT5107F & BT5104P; 2. BreathTech Child Resuscitator REF #s: BT3030, BT3034, & BT3025; 3. BreathTech Infant Resuscitator REF #s: BT2415K, BT2416, BT2032, BT2016, BT2035, BT2216, BT2036, BT2023, BT2026, BT2220-2, BT2020, BT2220, BT2220F, BT2215, BT2415, BT2014, BT2027, BT2015, BT2029, BT2037, BT2048, BT2034, BT2034W, BT2234, BT2234FK; 4. BreathTech Pediatric Resuscitator REF #s: BT4016, BT4019, BT4013, BT4018, BT4013F, BT4015, BT4006-N, BT4040, BT4022, BT4045, BT4024.
A backwards leak present in the integrated manometer of the patient valve allows for CO2 rebreathing.
US Nationwide distribution including in the states of AR, AZ, CA¿CO, CT, FL, GA, IA, IL, IN, KS, KY, LA, MA, MD, ME, MN, NC, ND, NH, NJ, NM, NV, NY, OH, SC, TN, TX, UT, VA, & WV.
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0362-2024