Description

The Avanos MIC-KEY Low-Profile Balloon Gastrostomy Button Kit (ENFit configuration) is a skin-level, low-profile G-tube designed for long-term enteral feeding, gastric decompression, and medication delivery in pediatric and adult patients. It may be placed percutaneously under fluoroscopic, laparoscopic, or endoscopic guidance and can serve as a replacement device through a mature stoma tract.

Key design features

• Low-profile, discreet button designed to minimize snagging and clothing interference
• Internal silicone balloon for retention; recessed/tapered distal tip at recommended fill volume
• Feeding port with anti-reflux valve that remains closed when no extension set is attached
• Radiopaque stripe (barium sulfate) for visualization
• High-clarity, medical-grade silicone construction; not formulated with natural rubber latex or DEHP

Connectivity and compatibility

• ENFit enteral connectivity
• Uses MIC-KEY extension sets only; SECUR-LOK patient-end connector helps reduce leaks and accidental disconnects and protects the valve
• Extension sets include a Y-connector medication port; Safety Ring design helps prevent misconnections

Kit contents (ENFit configuration)

• MIC-KEY Low-Profile Gastrostomy Feeding Tube
• Two ENFit extension sets (12 in/30 cm each):
• Continuous feed set: SECUR-LOK right-angle patient-end; 2-port Y with medication port; tubing clamp
• Bolus set: SECUR-LOK straight patient-end; ENFit feeding connector; tubing clamp
• 6 mL Luer Slip syringe (balloon inflation/deflation)
• 35 mL ENFit enteral syringe
• Gauze pads (4)
• Insertion stylet (US only)
• Water-soluble lubricant (US only)

Materials

• Tube: medical-grade silicone; polyether imide; polycarbonate; stainless steel spring; barium sulfate radiopaque stripe
• Extension sets: PVC (citrate plasticizer) and ABS; clamp polypropylene

Sterility and reuse

• Kit supplied sterile (ethylene oxide). G-tube is sterile, single-use; do not re-use, reprocess, or re-sterilize
• Extension sets are intended for repeated use by a single patient and are commonly supplied non-sterile when purchased separately; follow IFU for cleaning and replacement intervals

Sizing and balloon inflation

• 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
• Range notes: 12 Fr typically 0.8–4.0 cm; 14–24 Fr typically 0.8–5.0 cm; example variant: 20 Fr, 2.3 cm
• Balloon inflation with sterile or distilled water only:
• 12 Fr: recommended 3 mL; maximum 5 mL
• 14–24 Fr: recommended 5 mL; maximum 10 mL

Use and care highlights (see IFU)

• Attach a MIC-KEY extension set to open the anti-reflux valve for feeding/medication; cap when not in use
• Stabilize the tube and check balloon volume regularly to avoid dislodgement
• Use ENFit syringes for priming/flushing; prefer liquid medications; flush before and between medications
• Routine stoma and tube hygiene with mild soap and water; rotate the G-tube during care per IFU (do not rotate J/GJ devices)

Regulatory and compliance

• HCPCS: B4088; UNSPSC: 42231601
• CE marked (93/42/EEC), Class IIb; Notified Body: BSI (2797)
• TAA compliant: Yes; BAA compliant: No
• Manufacturer quality system: ISO 13485

Origin, storage, and shelf life

• Brand: MIC-KEY; Manufacturer: Avanos Medical (Avanos Medical Sales LLC); Country of origin: Mexico
• Store in a cool, dry place away from heat and radiation
• Shelf life: 2 years from date of manufacture