Description

The Avanos MIC-KEY Low-Profile Balloon Gastrostomy Button is a skin-level G‑tube designed for long-term enteral feeding, medication delivery, and gastric decompression in pediatric and adult patients who cannot tolerate oral intake and are at low risk for aspiration. It may be placed percutaneously under fluoroscopic, laparoscopic, or endoscopic guidance, or used as a replacement device via a mature stoma tract.

Key features

• Low-profile, button-style design in medical-grade silicone for a discreet profile
• Proximal anti‑reflux valve that closes when the extension set is disconnected
• SECUR‑LOK patient-end connectors; ventilated SECUR‑LOK external retention ring to promote air circulation and reduce pressure at the stoma
• Silicone internal retention balloon; distal tip is tapered and recessed at recommended fill volume
• Radiopaque barium sulfate stripe for visibility under imaging
• Not made with natural rubber latex; not formulated with DEHP

Materials

• Tube: silicone; polyether imide; polycarbonate; barium sulfate; stainless steel spring (valve)
• Extension sets: PVC with citrate softener; ABS components; polypropylene clamp

Sizes and stoma lengths

• French sizes: 12, 14, 16, 18, 20, 24 Fr
• Stoma lengths offered (availability varies by size): 0.8–5.0 cm overall • 12 Fr: 0.8–4.0 cm; 14/16/18/20 Fr: 0.8–5.0 cm; 24 Fr: 1.5–5.0 cm
• Available length increments (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

Balloon inflation (water only)

• Use sterile or distilled water only (do not use saline, tap water, or air)
• Recommended volumes: 12 Fr = 3 mL (max 5 mL); 14–24 Fr = 5 mL (max 10 mL)
• Stabilize the tube during inflation/deflation and verify balloon fill volume per size recommendations

Connectors and extension sets (ENFit)

• Use only MIC‑KEY extension sets with the MIC‑KEY feeding port
• Continuous feed set: SECUR‑LOK right‑angle patient‑end, ENFit Y‑connector with medication port, integrated clamp, ~30 cm (12 in)
• Bolus set: SECUR‑LOK straight patient‑end, ENFit connector, integrated clamp, ~30 cm (12 in)
• Extension sets are non‑sterile and reusable for a single patient; latex‑free and DEHP‑free

Kit contents (ENFit kit)

• 1 MIC‑KEY Low‑Profile Gastrostomy Button
• 1 Continuous Feed Extension Set and 1 Bolus Extension Set (as above)
• 1 × 6 mL Luer‑slip syringe (balloon) and 1 × 35 mL ENFit enteral syringe
• 4 gauze pads; some markets include an insertion stylet and water‑soluble lubricant

Sterility, packaging, and quality

• Tube/kit sterilized by ethylene oxide (ETO); extension sets supplied non‑sterile
• One complete kit in an individual sterile hard tray within a carton (~25.9 × 18.7 × 5.1 cm; ~431 g)
• Made in Mexico; manufacturing site certified to ISO 13485; CE marked under 93/42/EEC (MDD), Class IIb (BSI 2797)

Storage, handling, and cautions

• Store in a cool, dry place away from heat/radiation; shelf life 2 years from manufacture
• Device is single‑use; do not re‑use, re‑process, or re‑sterilize (extension sets are single‑patient reusable)
• Keep feeding port capped when not in use; replace extension sets regularly (e.g., weekly) per protocol/IFU
• Contraindications include ascites, colonic interposition, portal hypertension, peritonitis, and morbid obesity; see IFU for full list