Description

The Sheridan® Spiral-Flex® Endotracheal Tube by Teleflex is a specialized medical device engineered for reliable airway management. Its design incorporates a spiral-wound stainless steel reinforcing wire, embedded within the tube wall, to significantly reduce kinking and compression. This feature ensures consistent performance in situations where tube bending is likely, such as during head and neck surgeries or in patients with challenging airway anatomy.

Key Features

• Cuffed and Uncuffed Versions: Available for both oral and nasal intubation, suitable for adult and pediatric patients.
• High-Volume, Low-Pressure Cuff: Provides secure airway sealing in cuffed versions, with a blue cuff design.
• Smooth Beveled Tip and Murphy Eye: Facilitates atraumatic insertion and maintains airway patency.
• Integral Pilot Balloon and One-Way Valve: Allows precise control of cuff inflation and deflation in cuffed versions.
• Standard 15mm Connector: Bonded or supplied separately, depending on size.
• Reinforcing Sleeve and Bite Block: Included in the oral version, along with a pre-loaded stylet.
• X-ray Marker: Located at the distal tip for radiographic confirmation.

Material and Construction

The tube shaft is crafted from biocompatible polyvinyl chloride (PVC), with the cuff material designed to be thin-walled and low-pressure, not made with natural rubber latex. The device is supplied sterile and intended for single use, with sterilization achieved through ethylene oxide.

Intended Use

This endotracheal tube is designed to establish and maintain a patent airway for ventilation during anesthesia or emergency situations. Its robust construction makes it ideal for use with standard airway management equipment and compatible with both oral and nasal intubation techniques.

Regulatory Information

Classified as a Class II tracheal tube, it meets regulatory standards with FDA Regulation Number 868.5730 and Product Code BTR. The device is intended for prescription use only, ensuring it meets the stringent requirements for medical devices in its category.

Testing and Standards

The Sheridan® Spiral-Flex® Endotracheal Tube has undergone rigorous bench testing, including visual inspection, cuff performance, and biocompatibility assessments per ISO 10993-1:2009 and ASTM F623 standards. These tests confirm its reliability and safety for clinical use, providing healthcare professionals with a trustworthy tool for effective airway management.