Description

A skin-level, balloon-retained gastrostomy access device for long-term enteral feeding, medication delivery, and gastric decompression in pediatric and adult patients. The low-profile MIC-KEY button sits flush to reduce snagging and visibility and may be placed percutaneously under fluoroscopic, laparoscopic, or endoscopic guidance, or used as a replacement in an established stoma tract. Feeding is delivered via MIC-KEY extension sets with ENFit connections.

Design and materials

• Low-profile “button” at skin level
• High-clarity medical-grade silicone construction
• Internal inflatable retention balloon
• Feeding port with anti-reflux valve that remains closed when no extension set is attached
• Extension set port with protective cap; separate balloon inflation valve on the external base
• Radiopaque stripe for x-ray confirmation
• Not made with natural rubber latex; not made with DEHP as a plasticizer

Connectors and compatibility

• Interfaces exclusively with MIC-KEY extension sets featuring SECUR-LOK patient-end connectors
• ENFit feeding-side connections (ISO 80369-3) compatible with ENFit enteral syringes and administration sets
• SECUR-LOK design helps preserve valve integrity and minimize unintended disconnects

Sizes and balloon volumes

• French sizes: 12, 14, 16, 18, 20, 24 Fr
• Stoma 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
• Inflate balloon with sterile or distilled water only: 12 Fr recommended 3 mL (max 5 mL); 14–24 Fr recommended 5 mL (max 10 mL). Do not use air, saline, or contrast.

Kit contents (ENFit configuration)

• MIC-KEY Low-Profile G-Tube (button)
• Continuous Feed Extension Set, 12 in (30 cm), SECUR-LOK right-angle, Y-port with medication port and clamp
• Bolus Feed Extension Set, 12 in (30 cm), SECUR-LOK straight
• 35 mL ENFit enteral syringe; 6 mL Luer slip syringe (balloon)
• Gauze pads; insertion stylet (US only); water-soluble lubricant (US only)
• Note: Stoma measuring device not included

Sterility and re-use

• Button: sterile (EO), single use only. Do not reuse, reprocess, or resterilize. Do not use if packaging is damaged.
• Extension sets: non-sterile; reusable for a single patient only. Replace per clinician/IFU guidance.

Imaging and MRI

• Radiopaque stripe facilitates x-ray confirmation
• MR Conditional at 1.5 T or 3 T under labeling conditions (max spatial gradient ~19.6 T/m; whole-body SAR < 2 W/kg, Normal Operating Mode). Expected temperature rise ~1.3 °C after 15 minutes; image artifact may extend up to ~45 mm at 3 T (gradient echo).

Indications and contraindications (summary)

• Indicated for long-term gastric access in patients unable to maintain adequate oral intake and at low aspiration risk
• Contraindications include, but are not limited to: ascites, colonic interposition, portal hypertension, peritonitis, morbid obesity

Use and handling notes

• Always connect and flush through a MIC-KEY extension set; do not push fluids directly into the feeding port
• Engage SECUR-LOK per IFU and keep locked during use; unlock for disconnection
• Check balloon volume per clinician/IFU guidance using sterile/distilled water only

Regulatory

• Prescription use (Rx only). Information specific to gastro-jejunal devices does not apply to this G-tube configuration.