Description

Intended use

• Low-profile, skin-level gastrostomy button for long-term gastric access for enteral nutrition, medication delivery, and/or gastric decompression.
• Suitable for pediatric and adult patients who cannot tolerate oral feeding and are at low risk for aspiration.
• Placement options: percutaneous under fluoroscopic, laparoscopic, or endoscopic guidance; also suitable as a replacement device through an established stoma tract.

Design and key features

• Internal inflatable retention balloon to help maintain position.
• Feeding port with an anti-reflux valve that remains closed when no extension set is connected; valve opens with the extension set during use.
• MIC-KEY SECUR-LOK patient-end connector interface to help reduce leaks and accidental disconnects.
• Low-profile external base with recessed distal tip for a skin-level profile.
• Radiopaque stripe for radiographic confirmation of position.
• Safety Ring on the extension set’s patient-end to discourage misconnections.

Connectors and compatibility

• Use only MIC-KEY extension sets.
• Extension sets feature ENFit connectors (ISO 80369-3) on the feeding/syringe side.
• Ports: gastric feeding port on the button; a dedicated medication port is located on the Y-connector of the continuous-feed extension set.
• No jejunal feeding port.

Specifications (validated variant)

• Size: 24 Fr outer diameter
• Shaft (stoma) length: 4.5 cm
• Tip: recessed distal tip
• Radiopaque stripe: yes

Materials and safety

• Tube: high-clarity, medical-grade silicone; not made with natural rubber latex.
• Extension sets: natural rubber latex-free and DEHP-free.

Balloon information

• Balloon material: silicone.
• Inflation medium: sterile or distilled water only (do not use air or saline).
• Recommended fill volume (24 Fr): 5 mL; maximum 10 mL.
• Perform periodic balloon volume checks per Instructions for Use.

Regulatory and reusability

• G-tube: sterile (ethylene oxide sterilized); Rx only; single-use (do not reuse, reprocess, or resterilize).
• Extension sets: non-sterile; reusable for a single patient only.

MRI conditions

• MR Conditional at 1.5 T and 3 T.
• Maximum spatial field gradient ≤ 19.6 mT/m.
• Whole-body SAR ≤ 4 W/kg (Normal Operating Mode).
• Expected maximum temperature rise < 1.3 °C after 15 minutes.
• MR artifact typically < 45 mm at 3 T (gradient echo).

Kit contents (typical; may vary by region)

• MIC-KEY Low-Profile G-tube (button).
• Two ENFit extension sets: 12 in continuous feed (right-angle, Y with medication port and clamp) and 12 in bolus (straight with clamp).
• 6 mL Luer slip syringe (for balloon inflation/deflation).
• 35 mL ENFit enteral syringe.
• Gauze pad.
• Insertion stylet and water-soluble lubricant (availability varies by region).

Available sizes (product family)

• French sizes: 12, 14, 16, 18, 20, 24 Fr.
• Shaft lengths (approx.): 0.8–5.0 cm, including 4.5 cm as validated here.