Description

The Avanos MIC-KEY Low-Profile Balloon Gastrostomy (G) Button, ENFit configuration, is a skin-level feeding tube for long-term enteral nutrition, medication delivery, and gastric decompression in pediatric and adult patients. It may be placed under fluoroscopic, laparoscopic, or endoscopic guidance and is also suitable as a replacement device via an established stoma tract.

Design and materials

• High-clarity, medical-grade silicone button with an internal inflatable retention balloon
• Low-profile design to minimize snagging and clothing interference; radiopaque stripe on select models
• Feeding port with anti-reflux valve that stays closed without an extension and opens when a MIC-KEY extension set is attached
• Sterile; single-patient use; not made with natural rubber latex

Connections and compatibility

• Use only MIC-KEY G Extension Sets with the MIC-KEY G feeding port
• Patient-end SECUR-LOK right-angle connector with alignment marks and safety ring to protect the valve and help prevent misconnections
• ENFit feeding-side connections, including ENFit Y-port with a dedicated medication port on applicable extension sets

Kit contents (ENFit configuration)

• MIC-KEY Low-Profile Gastrostomy Button
• Two 12-inch MIC-KEY G extension sets: Continuous Feed and Bolus Feed (both with SECUR-LOK right-angle connectors)
• 6 mL luer slip syringe for balloon inflation/deflation
• 35 mL ENFit enteral syringe for bolus feeding, venting, priming, and flushing
• MIC-KEY Patient Use & Care Guide; gauze pad
• Insertion stylet (US only) and water-soluble lubricant (US only)
• Note: Stoma measuring device is not included

Sizes and balloon inflation

• French sizes: 12, 14, 16, 18, 20, 24 Fr; stoma lengths (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
• Inflate the balloon with sterile or distilled water only (do not use saline; do not overinflate)
• 12 Fr: recommended 3 mL, maximum 5 mL; 14–24 Fr: recommended 5 mL, maximum 10 mL

Use and handling highlights

• To connect an extension: align black marks, press in the SECUR-LOK connector, and turn clockwise until resistance; keep locked during feeding
• To disconnect: turn counter-clockwise until marks align and remove; cap when not in use
• Feeding: bolus via ENFit syringe; continuous via pump and giving set
• Flush the tube and extension sets before and after each use; do not introduce medications or formula directly into the feeding port valve
• Use only water-soluble lubricant as needed

Care, extension sets, and replacement

• Clean skin around the tube daily with mild soap and water; wash hands before handling; rotate the tube 360° plus a quarter turn during care
• Keep valve and port clean; avoid puncturing or tearing the tube or extension sets
• Extension sets: intended for continuous/pump and bolus feeding, medication administration, and venting; non-sterile, reusable for a single patient; not made with natural rubber latex and not made with DEHP; include a swivel to support movement; clean with warm, soapy water and rinse; flush before and after each use; replace approximately every 14 days (per IFU)

Fit and evaluation

• External base should sit about 1–2 mm above the skin
• A clinician determines proper stoma length; recheck if weight changes, the tube feels tight/loose, irritation or discomfort occurs, rotation is restricted, or the tube appears to be burying

Regulatory

• Prescription device (USA)