Description

The Avanos MIC-KEY Low-Profile Balloon Gastrostomy Button is a skin-level, balloon-retained G-tube designed for pediatric and adult patients who require long-term gastric access for enteral nutrition, medication delivery, or gastric decompression. This low-profile button is supplied with ENFit-compatible extension sets for both continuous pump feeding and bolus administration, supporting secure connections and routine care at home or in clinical settings.

Key features

• Medical-grade, high-clarity silicone tube with a radiopaque barium sulfate stripe for visualization.
• Internal silicone retention balloon; tapered distal tip recessed at recommended fill volume to help ease insertion and reduce mucosal contact.
• Feeding port with proximal anti-reflux valve that remains closed when no extension set is attached.
• SECUR-LOK patient-end connector interface for extension sets to help reduce leaks and accidental disconnects.
• Not made with natural rubber latex or DEHP.

Materials

• Tube/port components: silicone; polyether imide; polycarbonate; stainless steel spring (valve); barium sulfate stripe.
• Extension sets: PVC (citrate-softened) and ABS; clamp: polypropylene.

Sizes and balloon volumes

• French sizes: 12, 14, 16, 18, 20, 24 Fr.
• Stoma length ranges: 12 Fr 0.8–4.0 cm; 14–20 Fr 0.8–5.0 cm; 24 Fr 1.5–5.0 cm.
• Available 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.
• Balloon inflation (sterile/distilled water): 12 Fr 3 mL recommended (max 5 mL); 14–24 Fr 5 mL recommended (max 10 mL).

Connectors and kit contents

• Use only MIC-KEY extension sets with the MIC-KEY feeding port; ENFit connections on the feeding side accept ENFit syringes directly.
• Continuous (pump) extension: SECUR-LOK right-angle patient end; Y-connector with medication port; 30 cm (12 in).
• Bolus extension: SECUR-LOK straight patient end; ENFit feeding connector; 30 cm (12 in).
• Port cover provided when no extension set is attached.
• Kit includes: 1 MIC-KEY Low-Profile G-tube; 1 Continuous Feed Extension Set (ENFit, 30 cm) with Y-ports and clamp; 1 Bolus Extension Set (ENFit, 30 cm) with clamp; 1 6 mL luer slip syringe (balloon); 1 35 mL ENFit enteral syringe; gauze pads (typically 4). Some regions may also include an insertion stylet and water‑soluble lubricant. Stoma measuring device not included.

Sterility, indications, and contraindications

• G-tube: ETO sterilized; single-use only. Extension sets: non-sterile, single-patient reusable; replace per IFU.
• Indicated for patients needing long-term gastric access who cannot tolerate oral intake, are at low aspiration risk, and/or require decompression or medication delivery. May be placed percutaneously under fluoroscopic, endoscopic, or laparoscopic guidance; also suitable as a replacement in a mature tract.
• Example contraindications: ascites, colonic interposition, portal hypertension, peritonitis, morbid obesity.

Regulatory, MRI, packaging, and storage

• Manufactured in Mexico under an ISO 13485–compliant quality system; CE marked (93/42/EEC) Class IIb, BSI (2797). Prescription device where applicable (e.g., Rx only in the U.S.).
• MR Conditional; follow MRI safety information in the Instructions for Use.
• Packaged one kit per sterile hard tray; one tray per carton (approx. 25.9 × 18.7 × 5.1 cm; 431 g).
• Store in a cool, dry place away from heat and radiation; keep in dispenser box when possible. Shelf life: 2 years from date of manufacture.