Description

Intended use and placement

• Indicated for long-term enteral feeding, medication delivery to the stomach, and gastric decompression/venting in patients unable to tolerate oral intake and at low risk for aspiration.
• May be placed percutaneously under fluoroscopic, laparoscopic, or endoscopic guidance; also suitable as a replacement device via an established stoma tract.
• Prescription device (Rx only).

Design and key features

• Low-profile, skin-level gastrostomy “button” with an internal inflatable retention balloon.
• Proximal anti-reflux valve in the feeding port remains closed when no extension set is attached to help reduce backflow.
• Recessed distal tip (at recommended balloon fill) and radiopaque stripe to aid visualization during imaging.
• High-clarity, medical-grade silicone construction; not made with natural rubber latex.

Connectivity and ports

• Patient-end interface: MIC-KEY feeding port designed for MIC-KEY extension sets with SECUR-LOK right-angle connector and safety ring.
• External feeding interface: ENFit connectors on the compatible/included extension sets for standardized enteral connectivity.
• Medication port available via the ENFit Y-connector on the continuous-feed extension set.
• Jejunal port: none (gastrostomy device).

Sizes and specifications

• French sizes: 12, 14, 16, 18, 20, 24 Fr.
• Stoma length options (size-dependent): 0.8–5.0 cm; common discrete lengths include 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 cm (24 Fr typically 1.5–5.0 cm).
• Balloon fill with sterile/distilled water: 12 Fr recommended 3 mL (max 5 mL); 14–24 Fr recommended 5 mL (max 10 mL).

Materials and sterility

• Tube: medical-grade silicone with radiopaque (barium sulfate) stripe; components may include polyether imide/polycarbonate and a stainless steel spring.
• Device is sterile, sterilized by ethylene oxide (EtO). Single-use.
• ENFit extension sets: non-sterile, reusable for a single patient; materials include PVC (citrate plasticizer) and ABS; not made with natural rubber latex or DEHP.

Extension sets and typical kit contents

• Designed for the MIC-KEY feeding port; attach via SECUR-LOK right-angle connector that aligns and locks to protect the anti-reflux valve and reduce leakage.
• ENFit connectors on the feeding side; compatible with ENFit syringes and feeding sets.
• Typical kit includes two 12 in/30 cm extension sets: a right-angle continuous-feed set with ENFit Y-connector (dedicated medication port) and a straight bolus set.
• Supports continuous or bolus feeding, medication administration, and venting.

Handling and compatibility notes

• Use only MIC-KEY extension sets; do not insert syringes or formula directly into the button’s valve.
• To connect: align black lines, insert, and turn clockwise to lock; avoid overtightening ENFit connections.
• Flush the tube/extension before and after use. Extension sets are typically replaced about every two weeks for hygiene and function (per IFU/clinical guidance).