Description

The Avanos MIC-KEY Low-Profile Balloon Gastrostomy Button with ENFit Extension Sets is a skin-level, balloon-retained G-tube designed for long-term enteral nutrition, gastric decompression, and medication delivery in pediatric and adult patients. Its discreet profile helps minimize snagging and interference with clothing while supporting everyday mobility and comfort.

Intended Use

• Suitable for initial placement under fluoroscopic, laparoscopic, or endoscopic guidance, and for replacement through a mature stoma tract.
• G-tube configuration only; no jejunal feeding port.

Contraindications (non-exhaustive)

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

Design and Key Features

• Low-profile, skin-level “button” with inflatable internal retention balloon.
• Proximal anti-reflux valve remains closed when no extension set is attached.
• SECUR-LOK patient-end connector system on extension sets designed to reduce leaks and accidental disconnects and protect the valve.
• ENFit feeding connections provided via the included extension sets; continuous (Y) set includes a medication port.
• Radiopaque barium sulfate stripe for X-ray visibility.
• Tapered distal tip; tip is recessed at recommended balloon fill volume.
• High-clarity, medical-grade silicone for flexibility and drapability.
• Sterile, ethylene oxide (ETO) sterilized; tube is single-use and must not be reprocessed or re-sterilized.
• Not made with natural rubber latex or DEHP.

Materials

• Tube: medical‑grade silicone; components may include polyether imide, polycarbonate, stainless steel spring; radiopaque barium sulfate.
• Extension sets: PVC (citrate plasticizer) and ABS; clamp polypropylene; not made with natural rubber latex or DEHP.

Sizes and Options

• French sizes: 12, 14, 16, 18, 20, 24 Fr.
• Stoma length options (cm): 0.8, 1.0, 1.2, 1.5, 1.7, 2.0, 2.3, 2.5, 2.7, 3.0, 3.5, 4.0, 4.5, 5.0.
• Length ranges: 12 Fr = 0.8–4.0 cm; 14–20 Fr = 0.8–5.0 cm; 24 Fr = 1.5–5.0 cm.

Included Components

• 1 MIC-KEY Low-Profile Gastrostomy Feeding Tube (balloon-retained).
• 1 Continuous Feed Extension Set, 12 in/30 cm, SECUR-LOK right-angle patient-end, two ENFit connectors, closure cap, clamp.
• 1 Bolus Feed Extension Set, 12 in/30 cm, ENFit connector, SECUR-LOK straight patient-end, clamp.
• 1 Luer-slip syringe (6 mL) for balloon inflation/deflation.
• 1 ENFit enteral syringe (35 mL).
• Gauze pads (pack of 4).
• Insertion stylet and water‑soluble lubricant (US only).

Balloon Fill Guidance (use sterile/distilled water)

• 12 Fr: recommended 3 mL (maximum 5 mL).
• 14–24 Fr: recommended 5 mL (maximum 10 mL).

Handling and Storage

• Tube: single-use; extension sets are reusable for a single patient.
• Prescription use where applicable; CE marked medical device (Class IIb).
• Store in a cool, dry place away from heat/radiation.
• Shelf life: 2 years from date of manufacture.