Description

Intended use

• Low-profile, skin-level gastrostomy button with an internal inflatable balloon for delivery of enteral nutrition and medications to the stomach and/or gastric decompression.
• For patients needing long-term enteral access who cannot tolerate oral feeding and are at low risk for aspiration. Prescription use (where applicable).

Design and materials

• Low-profile “button” with external base and separate balloon inflation valve.
• Feeding port contains an anti-reflux valve that opens only when a MIC-KEY extension set is attached; do not inject directly into the valve.
• Radiopaque stripe for radiographic confirmation of placement.
• Medical-grade silicone construction; tube is sterile (ethylene oxide) and single-use.
• Not made with natural rubber latex; not made with DEHP.

Sizes and balloon guidance

• French sizes: 12, 14, 16, 18, 20, 24 Fr.
• Stoma (shaft) lengths generally ~0.8–5.0 cm, varying by French size.
• Balloon fill (sterile or distilled water only): 12 Fr 3 mL (max 5 mL); 14–24 Fr 5 mL (max 10 mL). Do not use air, saline, or contrast; do not overinflate.

Connectors and compatibility

• Patient-side port: MIC-KEY keyed SECUR-LOK twist-lock; use MIC-KEY extension sets only.
• Included extension sets are ENFit-compatible on the feeding/syringe side (connect to ENFit syringes and administration sets).
• Continuous Feed Extension Set: right-angle SECUR-LOK patient end; Y-connector with medication port and clamp.
• Bolus Feed Extension Set: straight SECUR-LOK patient end; ENFit feeding-side connector; typically no separate medication port.
• Extension sets are non-sterile, reusable for a single patient only, and not made with natural rubber latex or DEHP (do not reprocess/resterilize).

Kit contents (ENFit configuration)

• MIC-KEY Low-Profile G-Tube (button).
• Continuous Feed Extension Set, 12 in (right-angle, ENFit, Y-type with medication port and clamp).
• Bolus Feed Extension Set, 12 in (straight, ENFit).
• 35 mL ENFit enteral syringe; 6 mL luer-slip syringe for balloon inflation/deflation.
• Patient Use & Care Guide; gauze pads. Stoma measuring device not included. Some regions may include an insertion stylet and water-soluble lubricant.

MRI safety

• MR Conditional at 1.5 T and 3 T when used under specified conditions: maximum spatial field gradient ≤ 1,960 G/cm (≈19.6 T/m); whole-body SAR < 2 W/kg (Normal Operating Mode). Expected temperature rise < 1.3 °C after 15 minutes; imaging artifact may extend < 45 mm at 3 T (gradient-echo).

Placement and confirmation

• May be placed percutaneously under fluoroscopic, laparoscopic, or endoscopic guidance, or used as a replacement device via an established stoma tract. Radiopaque stripe aids confirmation.

Contraindications (examples)

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

Important cautions and precautions

• Tube is single-use sterile; do not reuse, reprocess, or resterilize. Do not use if packaging is damaged.
• Inflate the balloon with sterile or distilled water only and within stated volumes.
• For enteral use only. Use ENFit-compatible connections on the feeding side to help prevent misconnections.
• Always attach a MIC-KEY extension set to access the feeding port; do not inject into the anti-reflux valve directly.

Scope note

• Information applies to the MIC-KEY Low-Profile G-tube configuration; gastro-jejunal (GJ) device features do not apply.