Description

The Avanos MIC-KEY Low-Profile Balloon Gastrostomy Button (G-tube) with ENFit Extension Sets is a skin-level, balloon-retained gastrostomy device designed for long-term enteral feeding, direct medication delivery to the stomach, and gastric decompression. It is intended for patients who cannot tolerate oral intake and are at low risk of aspiration. The device may be placed percutaneously under fluoroscopic, laparoscopic, or endoscopic guidance, or used as a replacement in an established stoma tract.

Design and materials

• Low-profile external base for skin-level discretion and comfort
• Internal silicone retention balloon with proximal anti-reflux valve (opens when an extension set is attached)
• Recessed/tapered distal tip at recommended balloon fill
• Medical-grade silicone tube body with radiopaque barium sulfate stripe for visualization
• Not made with natural rubber latex; not made with DEHP plasticizer

Ports, connectors, and compatibility

• Feeding port uses the MIC-KEY SECUR-LOK patient-end interface; use only MIC-KEY extension sets
• Included extension sets feature ENFit connectors on the tubing/syringe ends for enteral-only compatibility
• Safety features include the SECUR-LOK right-angle connector and Safety Ring to help reduce leaks and misconnections
• Medication port: present on the continuous-feed Y extension set
• Jejunal feeding port: none (gastric device)

Included extension sets

• Continuous-feed right-angle Y set: ENFit, with medication port and tubing clamp
• Bolus/straight set: ENFit, with clamp
• Common length 30 cm (12 in); some continuous-feed sets also available in 60 cm (24 in)
• Non-sterile; reusable, single-patient use; latex-free; DEHP-free

Sizes and selection

• Available French sizes: 12, 14, 16, 18, 20, 24 Fr
• Available 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)
• Validated configuration in scope: 16 Fr × 2.5 cm

Balloon filling guidelines

• Fill balloon with sterile or distilled water only; do not use air, saline, or contrast
• 12 Fr: recommended 3 mL (max 5 mL)
• 14–24 Fr: recommended 5 mL (max 10 mL)
• For 16 Fr, recommended 5 mL

Kit contents (ENFit configuration)

• MIC-KEY Low-Profile G-tube
• Two 12 in (30 cm) MIC-KEY extension sets: one Continuous-Feed right-angle Y set with medication port and clamp; one Bolus straight set with clamp
• 6 mL Luer-slip syringe (for balloon inflation/deflation) and 35 mL ENFit enteral syringe
• Gauze pads
• In some regions, an insertion stylet and water-soluble lubricant are included
• Stoma measuring device not included

Regulatory and handling

• Tube is Rx only and supplied sterile (Ethylene Oxide)
• Do not reuse, reprocess, or resterilize the tube