Description

Avanos MIC-KEY Low-Profile Balloon Gastrostomy Button is a skin-level enteral access device for long-term gastric feeding, decompression, or clinician-directed medication delivery. The low-profile “button” rests at the skin surface to reduce snagging and improve comfort. This kit includes ENFit-compatible extension sets for bolus and continuous feeding. Selected variant: 12 Fr diameter, 1.7 cm stoma length.

Intended use and placement

• For patients who cannot tolerate oral feeding and need long-term enteral nutrition or gastric decompression.
• Suitable for percutaneous placement under fluoroscopic, laparoscopic, or endoscopic guidance, and as a replacement device in a mature stoma tract per clinician judgment.

Key design features

• Low-profile skin-level design with internal silicone retention balloon.
• Proximal anti-reflux valve that remains closed without an attached extension set.
• SECUR-LOK interface on the feeding port for secure connection of MIC-KEY extension sets.
• Tapered distal tip; recessed at recommended balloon fill; radiopaque stripe (barium sulfate) for visualization.
• Constructed of medical-grade silicone; not made with natural rubber latex or DEHP.

Selected variant and balloon parameters

• Size: 12 Fr; stoma length: 1.7 cm.
• Recommended balloon fill: 3 mL sterile/distilled water (maximum 5 mL). Use water only.

Kit contents

• MIC-KEY Low-Profile G-tube (sterile, single-use).
• Continuous Feed Extension Set, approx. 30 cm, right-angle patient-end SECUR-LOK, ENFit connectors, Y-port with medication port, clamp (non-sterile, single-patient reusable).
• Bolus Feed Extension Set, approx. 30 cm, straight patient-end SECUR-LOK, ENFit connector, clamp (non-sterile, single-patient reusable).
• 6 mL luer-slip syringe (balloon) and 35 mL male ENFit enteral syringe.
• Gauze pads.

Materials

• Tube: medical-grade silicone with radiopaque stripe; components may include polyether imide, polycarbonate, stainless steel spring.
• Extension sets: PVC with citrate plasticizer and ABS; clamp polypropylene. Not made with natural rubber latex; DEHP-free.

Handling and cautions

• Verify sterile package integrity before use; tube is single-use only and must not be reprocessed or resterilized.
• Extension sets are non-sterile and reusable for a single patient per IFU.
• Use only MIC-KEY extension sets with the SECUR-LOK port; lock during use.
• Do not inject formula or medication directly into the feeding port valve. Use ENFit syringes via the extension set and follow flushing/replacement intervals per IFU.
• Follow contraindications (e.g., ascites, colonic interposition, portal hypertension, peritonitis, morbid obesity) and clinician judgment.

Compatibility and standards

• ENFit connectors (ISO 80369-3) help prevent misconnections; ENFit syringes are required through the extension sets.

Storage and shelf life

• Sterilized by ethylene oxide; store in a cool, dry place away from heat/radiation. Shelf life 2 years from manufacture (check labeling).

Manufacturing and regulatory

• Manufacturer: Avanos; country of origin: Mexico. Quality system ISO 13485 compliant; CE marked Class IIb device.

Sizing support

• Over-the-wire stoma measuring device available separately to determine stoma length.