Description

Overview

The Avanos MIC-KEY Low-Profile Balloon Gastrostomy Button is a skin-level, balloon-retained gastrostomy tube designed for long-term enteral nutrition, gastric decompression, and medication delivery in pediatric and adult patients. Its unobtrusive profile supports patient comfort and discretion. Suitable for initial placement by trained clinicians or as a replacement in a mature tract.

Key features

• Low-profile, skin-level design to minimize external profile
• Proximal anti-reflux valve remains closed when no extension set is attached
• Internal inflatable retention balloon; distal tip recessed at recommended fill volume; tapered tip to aid placement
• High-clarity, medical-grade silicone for visibility and drapability
• Radiopaque barium sulfate stripe for imaging verification
• SECUR-LOK lock-and-key patient-end connection helps reduce leaks and accidental disconnects
• Not made with natural rubber latex; not formulated with DEHP

Materials

• Tube: silicone, polyetherimide, polycarbonate, barium sulfate, stainless steel spring
• Extension sets: PVC (citrate plasticizer) and ABS; clamp: polypropylene

Connectors and compatibility

• Button interfaces only with MIC-KEY extension sets via SECUR-LOK
• Included extension sets use ENFit (ISO 80369-3); continuous set features a Y-connector with a dedicated medication port and integrated clamp

Kit contents (ENFit configuration)

• MIC-KEY Low-Profile Gastrostomy Button
• Continuous Feed Extension Set, 12 in (30 cm), right-angle patient-end, ENFit Y-connector with medication port and clamp
• Bolus Feed Extension Set, 12 in (30 cm), straight patient-end, ENFit connector with clamp
• 6 mL Luer-slip syringe (for balloon inflation/deflation)
• 35 mL ENFit enteral syringe
• 4 gauze pads
• Insertion stylet (US only)
• Water-soluble lubricant (US only)

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
• Length ranges: 12 Fr (0.8–4.0 cm); 14–20 Fr (0.8–5.0 cm); 24 Fr (1.5–5.0 cm)

Balloon inflation

• Use sterile/distilled water
• 12 Fr: 3 mL recommended (5 mL max); 14–24 Fr: 5 mL recommended (10 mL max)

Sterility and reuse

• Button/tube: sterile (ethylene oxide); single-use only—do not reuse, reprocess, or re-sterilize
• Extension sets: non-sterile; reusable for a single patient only

Packaging, storage, and shelf life

• Individually packaged in a sterile hard tray; one tray per carton
• Store in a clean, dry, cool place away from heat and radiation
• Shelf life: 2 years from date of manufacture

Indications and contraindications

• Indicated for long-term enteral access when oral feeding is not tolerated, for gastric decompression, or direct medication delivery in patients at low risk of aspiration
• Contraindications include ascites, colonic interposition, portal hypertension, peritonitis, and morbid obesity

Regulatory and manufacturing

• CE marked under 93/42/EEC, Class IIb; Notified Body BSI (2797)
• Manufactured in Mexico; manufacturing site quality system certified to ISO 13485

Notes

• Specification describes the ENFit configuration; legacy catheter-tip MIC-KEY versions exist but are not included here