Description

Silicone balloon gastrostomy catheter for long‑term enteral feeding and/or gastric decompression via a previously established stoma. This device is intended as a replacement tube and is not for initial gastrostomy placement. Use only under the direction of a healthcare professional.

Compatibility

• ENFit patient‑end connection compliant with ISO 80369‑3 for enteral use.

Materials and Design Features

• Transparent, medical‑grade silicone; latex‑free and DEHP‑free.
• Internal silicone retention balloon for secure placement.
• 90° silicone external retention disc to aid fixation, support kink‑resistant bending, and help protect peri‑stomal skin.
• Quick‑release clamp to control flow during bolus feeding and help reduce backflow.
• Radio‑opaque along the entire length with 1 cm graduation markings for position verification.
• Color‑coded balloon inflation port indicates tube size.

Sizes and Balloon Fill Volumes

• CH14 (green): 5 mL sterile water
• CH18 (red): 10 mL sterile water
• CH20 (yellow): 15 mL sterile water

Balloon Inflation and Maintenance

• Inflate the balloon with water via the dedicated inflation port using a 10 mL Luer eccentric syringe.
• Maintain the manufacturer‑recommended balloon volume; check volume periodically as advised by a healthcare professional.
• The balloon fill volume is printed on the tube and/or inflation port for reference.

Handling and Care

• Maintain strict hygiene when handling feeds, tubes, and feeding sets.
• Flush the tube before and after feeds and medication administration, and at least three times daily.
• Verify that the external centimeter mark at the skin has not changed to monitor for migration.
• Position the external fixation disc approximately 2–5 mm from the skin; advance and rotate the tube periodically if advised by the care team.

Contraindications

• Do not place if the stoma site is infected, or in the presence of ascites or peritoneal carcinoma.

Storage

• Store in a clean, dry environment. Protect from dust, rain, and direct sunlight.