Description

Avanos MIC-KEY Low-Profile Balloon Gastrostomy Button is a skin-level, balloon-retained G-tube for long-term enteral feeding, medication delivery, and gastric decompression in pediatric and adult patients. It may be placed percutaneously under fluoroscopic, laparoscopic, or endoscopic guidance and can serve as a replacement device via a mature stoma tract. Gastric configuration only; no jejunal port.

Key features

• Low-profile “button” design helps reduce snagging and clothing interference for discreet wear.
• Internal inflatable retention balloon for secure placement.
• Proximal anti-reflux valve stays closed when no extension set is attached.
• ENFit connectivity via included extension sets; SECUR-LOK patient-end connectors minimize accidental disconnects and protect the valve.
• Medical-grade, high-clarity silicone with radiopaque (barium sulfate) stripe for imaging visibility.
• Tapered distal tip; recessed tip at recommended fill volume to help reduce gastric irritation.
• Natural rubber latex-free and DEHP-free.
• Supports bolus and continuous/pump feeding and venting.
• Sterile, single-use; EO sterilized. Prescription use (Rx only).

Sizes and balloon volumes

• French sizes: 12, 14, 16, 18, 20, 24 Fr.
• Stoma lengths (cm), availability by Fr size: 0.8–4.0 cm (12 Fr); 0.8–5.0 cm (14–20 Fr); 1.5–5.0 cm (24 Fr).
• Balloon inflation (sterile or distilled water only): 12 Fr 3 mL recommended (max 5 mL); 14–24 Fr 5 mL recommended (max 10 mL).
• Use only MIC-KEY G extension sets with the MIC-KEY feeding port; align marks and twist to lock during feeding.

Kit contents (ENFit configuration)

• MIC-KEY Low-Profile G-tube.
• Continuous Feed Extension Set, 12 in: right-angle SECUR-LOK patient-end; ENFit feeding side; Y-port with medication port; clamp.
• Bolus Feed Extension Set, 12 in: straight SECUR-LOK patient-end; ENFit feeding side; clamp.
• 35 mL ENFit enteral syringe; 6 mL luer slip syringe for balloon inflation/deflation; gauze pads.
• Insertion stylet and water‑soluble lubricant included in US kits only (not included in CE kits).
• Stoma measuring device not included.

Materials

• Tube: medical-grade silicone with radiopaque stripe; components may include polyether imide, polycarbonate, and a stainless steel spring in the valve assembly.
• Extension sets: PVC (citrate-softened) and ABS; polypropylene clamp.

Contraindications (non-exhaustive)

Ascites, colonic interposition, portal hypertension, peritonitis, and morbid obesity.

Regulatory and manufacturing

CE marked medical device (Class IIb) under an ISO 13485–compliant quality system; manufactured in Mexico.

Care and maintenance highlights (refer to IFU)

• Clean tube and stoma site with mild soap and water; rotate the tube 360° plus a ¼ turn during routine care.
• Flush extension sets with water before use; use only water‑soluble lubricant.
• Check balloon volume routinely per IFU; refill with sterile or distilled water as directed.