Description

Overview

A skin-level, balloon-retained gastrostomy feeding tube, the Avanos MIC-KEY low-profile “button” provides long-term enteral access for pediatric and adult patients. It supports gastric feeding, decompression, and direct medication delivery. Placement may be performed percutaneously under fluoroscopic, laparoscopic, or endoscopic guidance, and the device is also suitable as a replacement tube in a mature stoma tract.

Indications and contraindications

• Indications: long-term enteral feeding, gastric decompression, and medication delivery to the stomach.
• Contraindications (not exhaustive): ascites, colonic interposition, portal hypertension, peritonitis, morbid obesity. Single use only; do not re-use, re-process, or re-sterilize.

Key features and connectivity

• Low-profile button with proximal anti-reflux valve (closed when no extension set is attached).
• SECUR-LOK patient-end connector; design elements help reduce misconnections.
• Internal inflatable silicone retention balloon; tapered, recessed distal tip at recommended fill volume.
• Radiopaque barium sulfate stripe for imaging visibility.
• Not made with natural rubber latex or DEHP.
• Connectivity: designed for MIC-KEY extension sets only. ENFit feeding-side connections; the right-angle Y-extension includes a medication port. Gastric-only configuration (no jejunal port). ENFit configuration includes a medication port; non-ENFit versions exist without this port.

Sizes and balloon parameters

• 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.
• Typical availability: 12 Fr (0.8–4.0 cm); 14–20 Fr (0.8–5.0 cm); 24 Fr (1.5–5.0 cm).
• Balloon inflation (sterile/distilled water only): 12 Fr—3 mL recommended (max 5 mL); 14–24 Fr—5 mL recommended (max 10 mL). Do not use saline, tap water, or air.

Materials, sterility, and kit contents

• Materials (tube/valve): medical-grade silicone; polyetherimide; polycarbonate; stainless steel spring; barium sulfate stripe. Extension sets: PVC (citrate-softened) and ABS; clamp is polypropylene.
• Sterility: tube is sterile (EtO sterilized). Extension sets are non-sterile and reusable for a single patient.
• Kit typically includes: MIC-KEY low-profile G-tube; two ENFit extension sets—one continuous-feed right-angle Y with medication port and one straight bolus (each ~12 in/30 cm) with clamp and closure cap; 6 mL luer-slip syringe (balloon); 35 mL ENFit enteral syringe; gauze pads. In some markets, an insertion stylet and water‑soluble lubricant are included.

Handling, storage, and shelf life

• Use only MIC-KEY extension sets with the SECUR-LOK connector.
• Inflate/deflate balloon with sterile or distilled water only.
• Store in a cool, dry place away from heat and radiation. Shelf life: 2 years from date of manufacture.

Regulatory and manufacturing

Manufactured in Mexico under an ISO 13485-compliant quality system. CE marked under 93/42/EEC (MDD), Class IIb (Notified Body 2797).