Description

Overview and indications

A low-profile, skin-level gastrostomy “button” designed for long-term enteral nutrition, delivery of medications to the stomach, and gastric decompression. Suitable for pediatric and adult patients. May be placed initially (percutaneous under fluoroscopic, laparoscopic, or endoscopic guidance) or used as a replacement device through an established stoma tract.

Key design features

• Discreet, low-profile button to help minimize snagging and interference with clothing.
• Silicone inflatable internal retention balloon.
• Feeding port incorporates an anti-reflux valve that opens when a MIC-KEY extension set is attached and remains closed when not in use.
• Radiopaque stripe for visualization during placement assessment.
• ENFit connectivity compliant with ISO 80369-3; MIC-KEY extension sets attach via SECUR-LOK locking connectors.
• Medication port available through the ENFit Y-connector on the continuous feed extension set.
• G-tube configuration (no jejunal port).

Materials, sterility, and safety

• Tube made from high-clarity, medical-grade silicone; components may include polyetherimide, polycarbonate, barium sulfate for radiopacity, and a stainless steel spring.
• Not made with natural rubber latex; not made with DEHP.
• Sterile, ethylene oxide (ETO)–sterilized, single-use device (do not reuse/reprocess). Extension sets are non-sterile and reusable for a single patient.
• Prescription use (Rx) only. MR Conditional per IFU under specified MRI conditions.

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.
• Typical availability: 12 Fr (0.8–4.0 cm); 14/16/18/20 Fr (0.8–5.0 cm); 24 Fr (1.5–5.0 cm).

Balloon inflation volumes (use sterile/distilled water only)

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

Kit contents (ENFit configuration)

• Low-profile balloon-retained gastrostomy tube with ENFit extension port and cap.
• Continuous Feed Extension Set, 12 in/30 cm, ENFit, SECUR-LOK right-angle patient end, Y-connector with medication port, clamp.
• Bolus Feed Extension Set, 12 in/30 cm, ENFit, SECUR-LOK straight patient end, clamp.
• 6 mL Luer-slip syringe (balloon inflation/deflation).
• 35 mL ENFit enteral syringe.
• Gauze pads.
• Insertion stylet (US only).
• Water-soluble lubricant (US only).

Use and compatibility notes

• Use only MIC-KEY extension sets with the MIC-KEY feeding port; align and lock per SECUR-LOK design to help minimize leaks and accidental disconnects.
• Extension sets connect to ENFit syringes and ENFit administration sets.

Contraindications (examples; not exhaustive)

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