MIC ENFit Balloon Gastrostomy Tube

Description

The Avanos MIC Bolus Balloon Gastrostomy Feeding Tube is a balloon‑retained G‑tube designed for bolus feeding regimens in adult and pediatric patients who require long‑term enteral nutrition, gastric decompression, or direct medication delivery when oral intake is not possible and aspiration risk is low. Constructed from medical‑grade, high‑clarity silicone, it features an internal inflation balloon for internal retention and an external SECUR‑LOK stabilization ring to help maintain proper external position. A radiopaque stripe and centimeter markings support visualization and position checks. The device provides a single ENFit gastric feeding port and a separate balloon inflation port labeled "BAL." The distal tip is designed to be recessed at the recommended balloon fill volume; the 12 Fr size includes a tapered tip. Approximate tube length is 20 cm. The device is MR Safe and not formulated with natural rubber latex, DEHP, DBP, or BBP.

Key Features and Materials

• Balloon‑retained gastrostomy tube for bolus feeding (single gastric lumen)
• High‑clarity, medical‑grade silicone construction
• Internal silicone retention balloon
• SECUR‑LOK external retention ring/disc for external stabilization
• Radiopaque stripe (barium sulfate) for imaging visibility
• Centimeter markings along the tube
• Distal tip recessed at recommended fill; 12 Fr tapered tip
• Approximate length: ~20 cm
• MR Safe; not formulated with natural rubber latex, DEHP, DBP, or BBP

Ports and Connectivity

• One ENFit gastric feeding port (no separate medication or jejunal port)
• Dedicated balloon inflation/deflation port labeled "BAL" (balloon only)

Sizes and Balloon Fill Guidance

• 12 Fr: recommended fill 2–3 mL
• 14 Fr: recommended fill 3–5 mL
• 16 Fr: recommended fill 3–5 mL
• 18 Fr: recommended fill 7–10 mL
• 20 Fr: recommended fill 7–10 mL
• 22 Fr: recommended fill 7–10 mL
• 24 Fr: recommended fill 7–10 mL Some product materials list nominal balloon volumes of 5 mL (12 Fr) and 7–15 mL (14–24 Fr). Refer to the Instructions for Use for exact balloon fill volume for the specific size.

Placement and Use

May be placed surgically; percutaneously under fluoroscopic or endoscopic guidance; or used as a replacement through an established stoma tract. Supplied gamma‑sterile for single use only; do not re‑use, re‑process, or re‑sterilize. Prescription use only.

Regulatory and Manufacturing

• Manufacturer: Avanos Medical; manufactured in Mexico
• Manufacturing site quality system: ISO 13485 compliant
• CE marked under 93/42/EEC, Class IIb; Notified Body: BSI (2797)

Storage and Shelf Life

Store in a cool, dry place away from heat and radiation. Shelf life: 3 years from date of manufacture.

Contraindications (for gastrostomy tube placement)

• Ascites
• Colonic interposition
• Portal hypertension
• Peritonitis
• Morbid obesity

Packaging

Each tube is packaged gamma‑sterile in an individual Tyvek pouch; one pouch per carton; five cartons per shipping case. Unit and carton include linear barcodes.