Description

A standard-length, balloon-retained gastrostomy tube intended to provide access to the stomach for delivery of enteral nutrition and medications, with optional use for gastric decompression/venting. Suitable for adult and pediatric patients requiring long-term enteral feeding who cannot tolerate oral intake and are at low aspiration risk. The tube is made of high-clarity, medical‑grade silicone and interfaces with ENFit enteral connectors.

Key features and materials

• Medical‑grade silicone shaft (approx. 20 cm typical) with radiopaque stripe and centimeter markings for position verification.
• Internal silicone retention balloon; external SECUR‑LOK stabilization ring to help maintain external position.
• Distal tip: recessed at recommended fill on most sizes; tapered tip on 12 Fr.
• Not formulated with natural rubber latex, DEHP, DBP, or BBP.
• MR Safe.

Ports and connectivity

• ENFit gastric feeding port (single gastric lumen) for enteral feeding and medication delivery.
• Versions available with or without a separate medication port.
• Dedicated balloon inflation/deflation port labeled BAL (balloon only).

Sizes and balloon fill guidance

• 12 Fr: recommended 2–3 mL
• 14–16 Fr: recommended 3–5 mL
• 18–24 Fr: recommended 7–10 mL
• Size availability: with medication port up to 12–30 Fr; without medication port commonly 12–24 Fr.
• Refer to the device IFU for exact fill volumes and maximums.

Placement options

• May be placed surgically or percutaneously under fluoroscopic or endoscopic guidance, or used as a replacement through an established stoma tract.

Contraindications (non‑exhaustive)

• Ascites, colonic interposition, portal hypertension, peritonitis, morbid obesity.

Care and safety highlights

• For enteral use only; verify package integrity before use.
• Inflate balloon with sterile or distilled water only; do not use air, saline, or contrast. Check balloon water volume per clinical protocol.
• Position the external stabilization ring approximately 2–3 mm above the skin.
• Flush to maintain patency (preferably water); avoid acidic flushes and do not use excessive force.
• Prefer liquid medications; if crushing is permitted, dissolve thoroughly. Do not crush enteric‑coated medications or place medications in the balloon.
• Verify placement per institutional protocol (e.g., aspirate gastric contents; obtain radiographic confirmation when indicated).
• For removal, fully deflate the balloon and avoid excessive force.

Sterility and regulatory

• Supplied sterile (gamma sterilized); single use only. Do not re‑use, re‑process, or re‑sterilize.
• Prescription device (Rx only).
• Manufacturer: Avanos Medical; quality system ISO 13485 compliant; CE marked under 93/42/EEC (Class IIb).

Storage and shelf life

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