Description

Avanos MIC-KEY Low-Profile Balloon Gastrostomy (G) Button with ENFit Extension Sets is a skin-level, balloon-retained device that provides access to the stomach for long-term enteral feeding, medication delivery, or gastric decompression. It is intended for patients who cannot tolerate oral intake and are at low aspiration risk. The feeding port requires a MIC-KEY extension set. A low-profile external base sits about 2–3 mm above the skin to reduce snagging and improve discretion.

Key Features

• Low-profile, skin-level button for comfort and reduced visibility.
• Internal inflatable retention balloon; fill with sterile/distilled water only (no air, saline, or contrast).
• Anti-reflux valve stays closed without an extension set; flush only through an attached extension set—do not insert directly into the valve.
• Radiopaque stripe aids in confirming placement.

Connectivity and Compatibility

• Uses MIC-KEY extension sets only via SECUR-LOK patient-end connector (black alignment marks; ~¼‑turn lock).
• ENFit (ISO 80369‑3) connectors on extension sets; Y‑port for medications; enteral use only to prevent misconnections.

Materials and Sterility

• Medical-grade silicone; ethylene oxide sterilized; not made with natural rubber latex or DEHP.
• Single-use device; do not reuse, reprocess, or resterilize; do not use if package is damaged.
• Rx only (U.S.).

Kit Contents (ENFit configuration)

• MIC-KEY low-profile gastrostomy button with balloon valve, extension port/cap, and external base; two 12 in MIC-KEY extension sets: Continuous Feed (SECUR-LOK right-angle; ENFit; caps) and Bolus Feed (SECUR-LOK straight; ENFit; feeding/medication port).
• ENFit enteral syringe; 6 mL Luer slip syringe for balloon inflation/deflation; gauze pad(s); insertion stylet; water‑soluble lubricant (stylet/lubricant included in some regions, e.g., U.S.); Patient Use & Care Guide. Not included: stoma measuring device.

Sizes and Balloon Volumes

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

Placement and Use

• May be placed percutaneously under fluoroscopic, laparoscopic, or endoscopic guidance, or used as a replacement through an established stoma tract.
• To connect: align black marks, press down, and turn clockwise ~¼ turn to lock; counter‑clockwise to disconnect. Supports bolus (syringe) or continuous (pump) feeding.

Care and Maintenance

• Perform hand hygiene; cleanse peristomal skin daily with mild soap and water; keep port and cap clean.
• Rotate the G‑tube 360° plus ¼ turn during cleaning to help prevent sticking (not for jejunal/GJ tubes).
• Flush before and after every use; use only water‑soluble lubricant on the tube as needed; check balloon water volume periodically with sterile/distilled water per IFU/clinician guidance.

MRI Safety (MR Conditional)

• Safe at 1.5 T or 3 T; max spatial field gradient ≤ 1,960 G/cm (19.6 T/m); whole‑body SAR < 2 W/kg (Normal Mode).

Replacement and Resizing

• Replacement timing is clinician‑directed; re‑measure the stoma if weight changes, the tube feels tight/loose, there is stoma discomfort/irritation, or the tube does not rotate during maintenance.