Description

The Avanos MIC-KEY Low-Profile Balloon Gastrostomy Button is designed for long-term gastric access in patients who cannot tolerate oral intake. Its skin-level “button” profile reduces external protrusion while supporting enteral feeding, gastric decompression/venting, and direct medication delivery via compatible MIC-KEY extension sets equipped with ENFit (ISO 80369-3) connectors.

Intended use and placement

• Indicated for long-term enteral feeding in patients at low risk for aspiration
• Supports gastric decompression and medication administration
• May be placed percutaneously under fluoroscopic, laparoscopic, or endoscopic guidance
• Suitable as a replacement device through a mature stoma tract

Design and key features

• Low-profile, skin-level button with internal inflatable retention balloon
• Anti-reflux valve in the feeding port (remains closed when no extension set is attached)
• Recessed, tapered distal tip for comfort
• Radiopaque (barium sulfate) stripe for visualization on imaging
• High-clarity, medical-grade silicone construction
• Gastric-only configuration (no jejunal port)

Connectors and compatibility

• Patient end: MIC-KEY SECUR-LOK right-angle connector on the extension set mates to the button’s gastric port and protects the anti-reflux valve
• Feeding side: ENFit (ISO 80369-3) connectors for pump, syringe, or feeding set attachment
• Medication port: Located on the ENFit Y-connector of the continuous-feed extension set
• Use only MIC-KEY extension sets with the MIC-KEY G-tube

Extension sets (ENFit)

• Continuous-feed extension, 12 in: right-angle SECUR-LOK patient end, ENFit Y-connector with medication port, clamp; swivels for mobility
• Bolus extension, 12 in: straight ENFit connector with clamp
• Reusable for a single patient; supplied non-sterile; not made with natural rubber latex; DEHP-free

Sizes and selection

• French sizes: 12, 14, 16, 18, 20, 24 Fr
• Stoma (stem) lengths: 0.8–5.0 cm in common increments
• Suitable for pediatric through adult patients (select by French size and measured stoma length)

Balloon fill volumes (sterile/distilled water only)

• 12 Fr: recommended 3 mL; maximum 5 mL
• 14–24 Fr: recommended 5 mL; maximum 10 mL

Materials

• Tube: medical-grade silicone with barium sulfate radiopaque stripe; not made with natural rubber latex
• Extension sets: PVC with citrate softener; clamps polypropylene; not made with natural rubber latex; DEHP-free

Sterility and use

• G-tube: sterile, EtO sterilized; single-use (do not reuse, reprocess, or resterilize)
• Extension sets: non-sterile; reusable for a single patient
• Prescription use: Rx only

Kit contents (ENFit configuration)

• MIC-KEY Low-Profile G-tube (balloon-retained)
• 12 in Continuous Feed ENFit extension set with right-angle SECUR-LOK patient end (Y-connector with medication port) and clamp
• 12 in Bolus Feed ENFit extension set (straight) with clamp
• 6 mL Luer-slip syringe (for balloon inflation/deflation)
• 35 mL ENFit enteral syringe
• Gauze pad

Contraindications

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

Storage and shelf life

• Store in a cool, dry place away from heat and radiation
• Typical shelf life: 2 years from date of manufacture

Notes

• ENFit configuration is distinct from catheter-tip variants
• Supports feeding, medication delivery, and gastric decompression via compatible MIC-KEY extension sets