Description

Avanos MIC-KEY Low-Profile Balloon Gastrostomy Button (G-tube) is a skin-level feeding device for long-term enteral nutrition, gastric decompression, and direct medication delivery to the stomach. The low-profile button design helps reduce snagging and is suitable for pediatric and adult patients who cannot tolerate oral feeding or are at low risk for aspiration. It may be placed percutaneously under fluoroscopic, laparoscopic, or endoscopic guidance, or used as a replacement in a mature stoma tract.

Connectivity and access

• ENFit configuration designed for MIC-KEY ENFit extension sets only
• Feeding port features an anti-reflux valve that opens when an extension set is attached; connect via SECUR-LOK right-angle or straight connectors
• Medication port is provided via the ENFit Y-connector on ENFit extension sets
• Do not insert syringes directly into the button feeding port

Key features

• Low-profile, skin-level “button” design
• Internal silicone retention balloon; tapered distal tip with recessed tip at recommended fill volume
• Radiopaque barium sulfate stripe for visualization
• SECUR-LOK connectors to help minimize accidental disconnects and protect the valve

Sizes and lengths

• 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
• Size-specific length ranges: 12 Fr = 0.8–4.0 cm; 14–20 Fr = 0.8–5.0 cm; 24 Fr = 1.5–5.0 cm

Balloon fill volumes (sterile or distilled water only)

• 12 Fr: recommended 3 mL; maximum 5 mL
• 14, 16, 18, 20, 24 Fr: recommended 5 mL; maximum 10 mL
• Do not use air, saline, or contrast media to inflate the balloon

Typical ENFit kit contents

• MIC-KEY Low-Profile G-tube (button)
• Continuous Feed Extension Set, right-angle SECUR-LOK, ~12 in/30 cm
• Bolus Extension Set, straight SECUR-LOK, ~12 in/30 cm
• 6 mL luer-slip syringe (balloon inflation/deflation)
• 35 mL ENFit enteral syringe
• Gauze pads
• Regional variations: some kits include an insertion stylet and water‑soluble lubricant; stoma measuring device not included

Materials and composition

• Tube: medical-grade silicone with radiopaque barium sulfate stripe; components include polyether imide, polycarbonate, stainless steel spring
• Extension sets: PVC (citrate plasticizer) and ABS; clamp is polypropylene
• Not made with natural rubber latex; not made with DEHP

Sterility and use

• G-tube: ETO-sterilized; single-use; do not reuse, reprocess, or resterilize
• Extension sets: non-sterile; reusable for a single patient

MRI and regulatory information

• MR Conditional at 1.5 T and 3.0 T under conditions in the IFU
• Manufacturer: Avanos; manufactured in Mexico at an ISO 13485–compliant site
• CE marked under 93/42/EEC, Class IIb (Notified Body BSI 2797); prescription use only in the USA

Storage and shelf life

• Store in a cool, dry place away from heat and radiation; keep in the dispenser box when possible
• Shelf life: typically 2 years from date of manufacture

Contraindications (not exhaustive)

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

Notes

• Dimensions and characteristics may vary within specifications and are subject to change without notice
• Use only MIC-KEY ENFit extension sets with the MIC-KEY feeding port and follow the IFU for attachment/detachment to preserve the anti-reflux valve and minimize leakage