Description

The Avanos MIC-KEY Low-Profile Balloon Gastrostomy Button is a skin-level, balloon-retained enteral feeding tube for long-term nutrition, medication delivery, and gastric decompression in pediatric and adult patients. It may be used for initial placement under fluoroscopic, laparoscopic, or endoscopic guidance, or as a replacement through a mature stoma tract. Prescription device (Rx only).

Key features

• Low-profile external base sits flush to the skin to minimize snagging and clothing interference.
• High-clarity, medical-grade silicone tube with radiopaque stripe (barium sulfate) for visualization; recessed, tapered distal tip at recommended fill volume.
• Inflatable internal silicone retention balloon.
• Valved (anti-reflux) feeding port that remains closed when no extension set is attached.
• SECUR-LOK patient-end interface provides a keyed, secure connection to MIC-KEY extension sets to help reduce leaks and accidental disconnects.
• Natural rubber latex-free construction.

Connectors and compatibility

• Included extension sets feature ENFit connectors (ISO 80369-3) for enteral-only compatibility.
• Use only MIC-KEY extension sets with the MIC-KEY feeding port.

Kit contents (ENFit configuration)

• MIC-KEY Low-Profile Gastrostomy Feeding Tube (sterile).
• Continuous Feed Extension Set, 12 in/30 cm; SECUR-LOK right-angle patient end; ENFit 2-port Y with medication port; integrated clamp/caps.
• Bolus Feed Extension Set, 12 in/30 cm; SECUR-LOK straight patient end; ENFit; with clamp.
• 6 mL Luer-slip syringe for balloon inflation/deflation via balloon port.
• 35 mL ENFit enteral syringe.
• Gauze pad.
• Insertion stylet (US only).
• Water-soluble lubricant (US only).
• Note: Stoma measuring device is not included.

Sizes and options

• 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 (24 Fr typically 1.5–5.0 cm).
• Listing variant: 18 Fr with stoma length options 0.8–5.0 cm.

Balloon fill specifications

• Fill balloon only with sterile or distilled water (do not use air, saline, or contrast).
• Recommended volumes: 12 Fr = 3 mL (max 5 mL); 14–24 Fr = 5 mL (max 10 mL).

Sterility and reuse

• G-tube: sterile (ethylene oxide); single-use only—do not reuse, reprocess, or resterilize.
• Extension sets: non-sterile; reusable for a single patient; DEHP-free; natural rubber latex-free.

MRI safety

• MR Conditional at 1.5 T and 3 T under specified conditions (e.g., whole-body SAR ≤ 2 W/kg; maximum spatial gradient ≤ ~19.6 T/m). Expected maximum temperature rise < ~1.3 °C; image artifact typically < ~45 mm at 3 T (gradient echo).

Placement and replacement

• Can be placed percutaneously under fluoroscopic, laparoscopic, or endoscopic guidance; appropriate as a replacement device for a mature stoma tract.

Regulatory and origin

• Manufactured in Mexico under an ISO 13485-compliant quality system; CE marked medical device (Class IIb, NB 2797).

Safety notes

• Enteral-only device; ENFit connectors help prevent misconnections.
• Use MIC-KEY extension sets with SECUR-LOK patient-end connectors for compatible, secure attachment.