Description

Avanos MIC-KEY Low-Profile Balloon Gastrostomy Button is a skin-level, balloon-retained G-tube for long-term enteral nutrition, gastric decompression, and direct gastric medication delivery. The low-profile “button” sits close to the skin with an external base that rests slightly above the surface when correctly sized. Example configuration shown: 14 Fr outer diameter with 1.5 cm stoma length; a range of sizes is available.

Key design features

• Internal silicone retention balloon; tapered distal tip that is recessed at the recommended fill volume.
• Feeding port with anti-reflux valve; access only via a MIC-KEY extension set (do not inject directly into the valve).
• SECUR-LOK quarter-turn connector system with alignment marks for secure attachment of MIC-KEY extension sets.
• Radiopaque barium-sulfate stripe for fluoroscopic visualization.
• G-tube configuration only (no jejunal feeding port).

Connectivity and kit contents (ENFit configuration)

• Button interfaces exclusively with MIC-KEY extension sets featuring SECUR-LOK patient-end connectors.
• Extension sets present ENFit connectors for ENFit syringes/administration sets.
• Included: continuous feed extension set (right-angle, ENFit Y-connector with medication port, clamp), bolus extension set (straight, ENFit, clamp), 35 mL ENFit enteral syringe, 6 mL luer-slip syringe for balloon, gauze pads, insertion stylet and water-soluble lubricant (US only).

Materials and biocompatibility

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

Sizes and balloon fill guidance

• French sizes: 12, 14, 16, 18, 20, 24 Fr; stoma lengths from 0.8 to 5.0 cm (availability varies by size).
• Balloon fill with sterile/distilled water only: 12 Fr 3 mL (max 5 mL); 14–20 Fr 5 mL (max 10 mL); 24 Fr 5 mL (max 15 mL).

Sterility and handling

• G-tube is sterile, single-use, EtO sterilized; do not reuse or re-sterilize; do not use if packaging is damaged.
• Extension sets are non-sterile and reusable for a single patient; replace per Instructions for Use.

MRI safety

• MR Conditional at 1.5 T and 3 T; max whole-body SAR 2 W/kg (Normal Operating Mode).
• Expected temperature rise < 1.3 °C after 15 minutes; image artifact < 45 mm on 3 T gradient-echo sequences.

Regulatory

• Prescription device (Rx only, USA). CE marked (Class IIb) under an ISO 13485–compliant quality system (Notified Body: BSI 2797).

Storage and shelf life

• Store in a cool, dry place away from heat and radiation. Shelf life: 2 years from date of manufacture.

Important notes and contraindications

• Select size by measuring stoma length (measuring device not included). Follow IFU for care, flushing, and replacement intervals.
• Contraindications include, but are not limited to: ascites, colonic interposition, portal hypertension, peritonitis, and morbid obesity (refer to IFU for full list).