Description

The Avanos MIC-KEY Low-Profile Balloon Gastrostomy Button is a skin-level feeding tube made of medical‑grade silicone for pediatric and adult patients. It includes an inflatable internal retention balloon and a proximal feeding port with an anti‑reflux valve that remains closed when no extension set is attached. The SECUR‑LOK connector enables secure attachment of MIC‑KEY extension sets. A tapered, recessed distal tip (at recommended balloon fill) supports comfortable insertion, while a radiopaque stripe containing barium sulfate aids visualization.

Connectors and compatibility

• ENFit (ISO 80369‑3) interface via MIC‑KEY extension sets
• Use only MIC‑KEY extension sets with the MIC‑KEY feeding port
• SECUR‑LOK right‑angle patient‑end helps reduce leaks and accidental disconnects; Y‑connector includes a dedicated medication port

Sizes and balloon inflation

• 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
• 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 with sterile or distilled water:
• 12 Fr: recommended 3 mL; maximum 5 mL
• 14–24 Fr: recommended 5 mL; maximum 10 mL

Kit contents (ENFit configuration)

• MIC‑KEY Low‑Profile G‑tube
• Continuous Feed Extension Set: SECUR‑LOK right‑angle patient‑end with 2‑port ENFit Y‑connector, closure cap and clamp; length ~12 in/30 cm
• Bolus Extension Set: ENFit connector with SECUR‑LOK straight connector and clamp; length ~12 in/30 cm
• 6 mL Luer‑Slip syringe (balloon inflation/deflation)
• 35 mL ENFit enteral syringe
• Gauze pads (4)
• Insertion stylet and water‑soluble lubricant may be included in some regions

Materials and sterility

• Tube: silicone, polyether imide, polycarbonate, barium sulfate, stainless steel spring
• Extension sets: PVC (citrate plasticizer) and ABS; clamp: polypropylene
• Not made with natural rubber latex or DEHP
• Kit is sterile (ethylene oxide); device is single‑use—do not re‑use, re‑process, or re‑sterilize
• Stand‑alone MIC‑KEY extension sets (sold separately): non‑sterile; reusable for a single patient only

Intended use, contraindications, and placement

• For long‑term enteral feeding in patients who cannot tolerate oral intake, are at low aspiration risk, and/or require gastric decompression or direct medication delivery
• May be placed initially or used as a replacement in a mature stoma tract
• Contraindications include ascites, colonic interposition, portal hypertension, peritonitis, morbid obesity
• Placement under fluoroscopic, laparoscopic, or endoscopic guidance, or via an established stoma tract

Packaging, manufacturing, and storage

• One complete kit per sterile hard tray; one tray per carton (approx. 25.9 × 18.7 × 5.1 cm; ~431 g)
• Manufactured in Mexico at an ISO 13485‑compliant site; CE‑marked under 93/42/EEC, Class IIb (CE 2797)
• Store in a cool, dry place away from heat/radiation; keep in dispenser box when possible; shelf life 2 years from date of manufacture