Description

Overview

The Avanos MIC-KEY Low-Profile Balloon Gastrostomy Button (20 Fr) is a skin-level feeding tube retained by an internal inflatable balloon. It is intended for long-term enteral delivery of nutrition and medications and for gastric decompression/venting in pediatric and adult patients. The low-profile design sits discreetly at the stoma to minimize interference with clothing and daily activities.

Intended use and patient selection

• Indicated for patients requiring long-term enteral feeding and/or gastric decompression.
• Common contraindications include, but are not limited to: ascites, colonic interposition, portal hypertension, peritonitis, and morbid obesity.

Design and safety features

• Low-profile button with internal inflatable retention balloon.
• Feeding port includes an anti-reflux valve that remains closed when no extension is attached; administer and flush only through the extension set (do not insert a syringe directly into the valve).
• Radiopaque stripe for position verification.
• MR Conditional.

Connections and compatibility

• ENFit-based system: the MIC-KEY button connects to MIC-KEY extension sets; extension sets connect to ENFit syringes and ENFit feeding sets.
• SECUR-LOK patient-end locking mechanism helps reduce leaks and accidental disconnects; patented universal connector intended to help preserve tube/valve life.
• Use only MIC-KEY extension sets with the MIC-KEY feeding port.

Materials and sterility

• High-clarity, medical-grade silicone construction.
• Sterile device; sterilized with ethylene oxide (ETO).
• Not made with natural rubber latex; not made with DEHP.

Kit contents (ENFit configuration)

• MIC-KEY Low-Profile Gastrostomy Feeding Tube (20 Fr) with ENFit interface (used via extension sets).
• Continuous Feed Extension Set, 12 in (~30 cm), with SECUR-LOK right-angle connector, two-port Y with medication port, and integrated clamp (non-sterile; reusable for a single patient; latex-free; DEHP-free).
• Bolus Feed Extension Set, 12 in (~30 cm), with SECUR-LOK straight connector (non-sterile; reusable for a single patient; latex-free; DEHP-free).
• 6 mL Luer slip syringe (for balloon inflation/deflation).
• 35 mL ENFit enteral syringe.
• Gauze pad.
• Insertion stylet (US only).
• Water‑soluble lubricant (US only).
• Stoma measuring device not included.

Sizes and balloon fill (20 Fr)

• Available 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.
• Balloon fill: recommended 5 mL; maximum 10 mL. Use sterile/distilled water only. Do not use air, saline, or contrast.

Placement and replacement

• May be placed percutaneously under fluoroscopic, laparoscopic, or endoscopic guidance, or used as a bedside replacement into an established stoma tract.
• External base should rest slightly above the skin (~2–3 mm) to allow cleaning and reduce pressure.

MRI safety (MR Conditional)

• 1.5 T or 3 T; maximum spatial gradient 1,960 G/cm (19.6 T/m) or less; whole-body SAR < 2 W/kg (Normal Operating Mode).
• Expected heating < 1.3 °C after 15 minutes of continuous scanning.
• Image artifact extends < 45 mm at 3 T (gradient echo).

Labeling

Prescription use only. Single-use device. Do not resterilize. Do not use if package is damaged. Use only with MIC-KEY extension sets and ENFit connections as intended.