Description

Overview

A skin-level, balloon-retained gastrostomy button designed for long-term enteral feeding, medication delivery, and/or gastric decompression in pediatric and adult patients. Suitable for initial placement under fluoroscopic, laparoscopic, or endoscopic guidance, or for replacement through a mature stoma tract.

Design and features

• Low-profile, discreet button that sits at skin level.
• Internal inflatable retention balloon.
• Feeding port with proximal anti-reflux valve that remains closed when no extension set is attached.
• SECUR-LOK twist-to-lock interface (align marks, push down, turn to lock; counter-clockwise to disconnect).
• Tapered distal tip with radiopaque stripe for visualization.

Sizing 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 varies by size).
• Typical ranges: 12 Fr = 0.8–4.0 cm; 14–20 Fr = 0.8–5.0 cm; 24 Fr = 1.5–5.0 cm. Example: 18 Fr × 4.5 cm.
• Balloon inflation (sterile or distilled water): 12 Fr—recommended 3 mL (max 5 mL); 14–24 Fr—recommended 5 mL (max 10 mL).

Materials and safety

• Button tube: high-clarity, medical-grade silicone; radiopaque stripe contains barium sulfate. Components may include polyether imide and polycarbonate.
• Not made with natural rubber latex or DEHP.

Sterility and reuse

• Button: sterile (ethylene oxide); single-use only—do not reprocess or re-sterilize.
• Extension sets: non-sterile; reusable for a single patient only—do not share between patients.

Connectors and compatibility

• ENFit (ISO 80369-3) feeding-side connections to help minimize misconnections.
• Use only MIC-KEY extension sets with the MIC-KEY feeding port.

What’s in the ENFit kit

• MIC-KEY Low-Profile Gastrostomy Button.
• Two ENFit extension sets (approx. 12 in/30 cm each):
• Continuous Feed Extension: SECUR-LOK right-angle patient-end, two-port Y with medication port, integrated clamp.
• Bolus Feed Extension: ENFit feeding connector, SECUR-LOK straight connector with clamp.
• 6 mL Luer-slip syringe (balloon inflation/deflation).
• 35 mL ENFit enteral syringe.
• Gauze pad.
• Insertion stylet and water-soluble lubricant in some regional kits (e.g., US-only).

Extension set characteristics

• Materials: DEHP-free, not made with natural rubber latex; typical materials include PVC (citrate plasticizer) and ABS; clamp is polypropylene.
• Available separately in multiple lengths (commonly 30 cm and 60 cm) with SECUR-LOK right-angle connector, Y-connector with medication port, and integrated clamp.

Indications and contraindications (summary)

• Indicated for patients needing long-term gastric access for feeding, decompression, and/or medication delivery.
• Example contraindications (non-exhaustive): ascites, colonic interposition, portal hypertension, peritonitis, morbid obesity. Refer to the device IFU for full indications, precautions, and instructions for use.