Description

Overview

The Avanos MIC-KEY Low-Profile Balloon Gastrostomy (G) Button is a skin-level feeding tube designed for long-term enteral nutrition, medication administration, and gastric decompression in pediatric and adult patients. It is suitable for initial placement under endoscopic, laparoscopic, or fluoroscopic guidance and for replacement through an established stoma tract. This product is a gastric (G) button only and does not include a jejunal lumen.

Construction and sterility

• Tube: High-clarity, medical-grade silicone; natural rubber latex-free
• Internal retention: Inflatable balloon (fill with sterile/distilled water only)
• Feeding port: Anti-reflux valve; separate balloon inflation port
• Sterility: EO sterilized (device); extension sets are non-sterile, single-patient reusable

Connections and compatibility

• Patient-end interface: MIC-KEY SECUR-LOK right-angle connection between the button and extension set (align-and-twist lock)
• Distal interface (extension sets): ENFit (ISO 80369-3) connectors for ENFit syringes and administration sets
• Use only MIC-KEY extension sets with the MIC-KEY feeding port; ENFit syringes connect directly to the ENFit end of the extension set

Sizes and balloon guidance

• French sizes: 12, 14, 16, 18, 20, 24 Fr
• Stoma (stem) lengths: 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
• Example variant: 20 Fr, 1.2 cm length
• Balloon inflation (sterile/distilled water only): 12 Fr—recommended 3 mL (max 5 mL); 14–24 Fr—recommended 5 mL (max 10 mL)

Kit contents (ENFit configuration)

• MIC-KEY Low-Profile G Button (sterile)
• ENFit extension sets: 12 in Continuous Feed and 12 in Bolus Feed (both with SECUR-LOK right-angle patient end)
• 35 mL ENFit enteral syringe; 6 mL Luer slip syringe (for balloon)
• Gauze pad; insertion stylet (US only); water-soluble lubricant (US only)

MIC-KEY ENFit extension sets

• Intended use: Attach to MIC-KEY low-profile G, J, or GJ tubes for delivery of nutrition/medications; disconnect between feeds for comfort
• Connector configuration: SECUR-LOK right-angle patient end; ENFit distal end; Y-connector versions include a dedicated medication port; tubing clamp included
• Length options: Commonly 30.5 cm (12 in) and 60.9 cm (24 in); kit includes 12 in continuous and 12 in bolus sets
• Materials: Tubing/connector PVC with adipate softener; patient connector ABS and polyurethane; clamp polypropylene
• Safety: Not formulated with natural rubber latex; DEHP-free (commonly DBP/BBP/BPA-free per product literature)
• Use/Replacement: Non-sterile, reusable for a single patient; change at least every 2 weeks
• Packaging/Regulatory: Individually pouched; typically cartons of 5; manufactured in Mexico at an ISO 13485–compliant site; CE marked medical device (Class IIa; NB 2797)
• Storage/Shelf life: Store cool, dry, away from heat/radiation; typical shelf life 5 years

Important notes

• Use only sterile/distilled water for balloon inflation; do not use saline
• Do not inject feeds or medications directly into the button’s valve—attach a MIC-KEY extension set and use ENFit connections
• Legacy syringes may require an adapter during ENFit transition

Manufacturer and origin

• Brand: MIC-KEY (Avanos Medical)
• Country of origin: Mexico