Description

The ENFit MIC Bolus Balloon Gastrostomy Tube by Avanos Medical Australia is a specialized medical device crafted from high-quality silicone, designed to support long-term enteral feeding, gastric decompression, and direct medication delivery. This device is intended for both pediatric and adult patients who cannot tolerate oral feeding and are at low risk for aspiration.

Key Features

• ENFit Connector: Equipped with a male feeding port, and in some models, a medication port, ensuring secure and efficient feeding connections.
• Internal Retention Balloon: An inflatable silicone balloon that provides secure placement within the stomach.
• SECUR-LOK External Retention Ring: Offers stability and minimizes tube movement.
• Distal Tip Design: Tapered and recessed, except in the 12 Fr size, enhancing comfort and functionality.
• Radiopaque Stripe: Includes a barium sulphate stripe for easy visibility under imaging.

Material and Safety

• Constructed from medical-grade silicone, Tritan, and barium sulphate.
• Free from natural rubber latex, DEHP, DBP, and BBP, ensuring compatibility with sensitive patients.
• MR safe and sterilized by gamma radiation.
• Designed for single-use to maintain hygiene and safety standards.

Available Sizes

The tube is available in a range of French sizes from 12 to 30, with balloon volumes tailored to specific sizes:

• 12 Fr: 2-3 ml
• 18-24 Fr: 7-10 ml (specifically for 18, 20, 22 Fr)

Packaging and Storage

Each tube is individually packaged in a Tyvek pouch, providing protection and sterility. It is recommended to store the device in a cool, dry place.

Regulatory Information

• CE marked as a Class IIb medical device.
• Manufactured in an ISO13485-compliant facility in Mexico.
• Offers a shelf life of 3 years.

Placement Methods

The tube can be placed surgically or percutaneously under fluoroscopic or endoscopic guidance, and can also be replaced via an established stoma tract.

Contraindications

Use of this device is contraindicated in patients with conditions such as ascites, colonic interposition, portal hypertension, peritonitis, and morbid obesity.

Continuous Improvement

Product characteristics and dimensions may vary within pre-established specifications as part of Avanos Medical's commitment to continuous improvement.