Percutaneous Dilation - Tracheostomy Set and Tracheostomy Tube - India CDSCO Medical Device Registration

Product Information

Intended Use: From the TRACOE percutan product line: The TRACOE experc dilation set (TRACOE Vario) is intended for performing a percutaneous dilation tracheotomy, applying the Ciaglia technique with a Seldinger guide wire. The TRACOE Seldinger Guide Wire with Guiding Catheter (TRACOE Vario) facilitates the reinsertion when changing the TRACOE twist tracheostomy tubes with minimally traumatic inserter. The TRACOE Seldinger Guide Wire (TRACOE Vario) facilitates the reinsertion when changing TRACOE twist plus tracheostomy tubes with minimally traumatic insertion system, TRACOE vario tracheostomy tubes with minimally traumatic insertion system, and all TRACOE tracheostomy tubes with perforated obturator. For vario tracheostomy tubes included in the experc sets: TRACOE vario tracheostomy tubes are indicated for providing tracheal access for airway management especially to those patients with unusual anatomy or patients with thick necks It may be used for up to 29 days. Patient Population: Adults and adolescents (TRACOE Vario) For twist tracheostomy tubes included in the experc sets: The TRACOE twist and TRACOE twist plus tracheostomy tubes are used as ventilation and therapy tubes with inner cannulas in hospitals, rehabilitation, and community settings