Description

Overview

The Avanos MIC-KEY Low-Profile Balloon Gastrostomy Button is a skin-level, balloon-retained G-tube designed to provide direct gastric access for enteral 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 device in a mature stoma tract.

Key features

• Low-profile “button” sits at skin level to reduce snagging and enhance discretion.
• Internal inflatable silicone retention balloon; fill only with sterile or distilled water.
• Feeding port with an anti-reflux valve that remains closed when no extension set is attached.
• SECUR-LOK patient-end connector for secure attachment of MIC-KEY extension sets without damaging the valve.
• Tapered distal tip; tip recesses at the recommended balloon fill volume.
• Radiopaque (barium sulfate stripe) for visualization.
• Not made with natural rubber latex or DEHP.

Sizes and stoma lengths

• 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 varies by size; 24 Fr typically 1.5–5.0 cm).

Balloon inflation (sterile/distilled water)

• 12 Fr: recommended 3 mL; maximum 5 mL.
• 14–24 Fr: recommended 5 mL; maximum 10 mL.

Connectors and compatibility (ENFit configuration)

• MIC-KEY extension sets attach via the SECUR-LOK patient-end connector and provide ENFit (ISO 80369-3) connections on the feeding side.
• Common extension sets: Continuous Feed (right‑angle Y-connector with medication port) and Bolus Feed (straight connector). Sets swivel and include an integral clamp; intended for single‑patient reuse and commonly replaced about every two weeks.
• Use only MIC-KEY extension sets with the MIC-KEY feeding port. Legacy catheter‑tip versions exist but are distinct from ENFit configurations.

Kit contents (typical ENFit configuration)

• MIC-KEY Low-Profile G-tube.
• Continuous Feed Extension Set with ENFit, approx. 12 in/30 cm.
• Bolus Feed Extension Set with ENFit, approx. 12 in/30 cm.
• 6 mL luer‑slip syringe (balloon inflation/deflation).
• 35 mL ENFit enteral syringe.
• Gauze pads; Instructions for Use and patient care guide. Regional variations may include an insertion stylet and water‑soluble lubricant.

Materials and sterility

• G-tube: medical-grade silicone; components may include polyether imide, polycarbonate, barium sulfate, and a stainless‑steel spring.
• Extension sets: PVC with citrate plasticizer, ABS fittings, polypropylene clamp. Free of natural rubber latex and DEHP.
• G-tube is sterile (EtO); single use only. Extension sets are non‑sterile; reusable for a single patient.

Storage and regulatory

• Store in a cool, dry place away from heat/radiation. Typical shelf life: 2 years from manufacture.
• Supplied as a sterile tray (kit); one tray per carton.
• Manufactured by Avanos in an ISO 13485–compliant facility; CE marked (Class IIb) and FDA 510(k)-cleared Class II.

Contraindications and precautions

Contraindications may include ascites, colonic interposition, portal hypertension, peritonitis, or morbid obesity. Follow the Instructions for Use for complete indications, contraindications, warnings, and precautions. Dimensions and availability may vary within specifications and are subject to change without notice.