Description

A skin-level, low-profile “button” gastrostomy feeding tube designed for long-term enteral nutrition, gastric decompression, and direct medication delivery in pediatric and adult patients. This ENFit configuration of the Avanos MIC-KEY G-tube incorporates a retention balloon, anti-reflux valve, and SECUR-LOK patient-end interface, and is supplied with ENFit-compatible extension sets.

Intended use

• For initial percutaneous placement under fluoroscopic, laparoscopic, or endoscopic guidance, or for replacement through a mature stoma tract.
• Prescription use (Rx) only.

Key design and features

• Low-profile, unobtrusive button helps minimize snagging and clothing interference.
• Inflatable internal retention balloon.
• Feeding-port anti-reflux valve remains closed when no extension set is attached.
• SECUR-LOK right‑angle patient-end interface to protect the valve and reduce accidental disconnects; use only MIC-KEY extension sets.
• Recessed/tapered distal tip for comfort; radiopaque stripe for visualization.
• High-clarity, medical‑grade silicone; natural rubber latex‑free and not formulated with DEHP.
• Jejunal port: none; medication access via Y-connector on the continuous-feed extension set.

Connectors and compatibility

• Extension sets provide ENFit (ISO 80369‑3) feeding-side connections.
• Included extension types: Continuous (right‑angle Y‑connector with medication port) and Bolus (straight); both include a tubing clamp. Closure cap is included on the right‑angle set.
• ENFit syringes connect directly to the extension sets.

Materials

• Tube: silicone; components may include polyether imide, polycarbonate, barium sulfate (radiopaque stripe), and a stainless steel spring (valve mechanism).
• Extension sets: PVC (citrate plasticizer) and ABS; clamp polypropylene. Latex‑free and DEHP‑free.

Sterility and reuse

• G‑tube: sterile, ethylene oxide (EO/EtO) sterilized; single-use only. Do not reuse, reprocess, or resterilize. Verify package integrity before opening.
• Extension sets: non‑sterile; reusable for a single patient only (not to be shared).

Sizes and options

• French sizes: 12, 14, 16, 18, 20, 24 Fr.
• Typical stoma lengths (availability varies by French size/region): 12 Fr 0.8–4.0 cm; 14 Fr 0.8–5.0 cm; 16 Fr 3.5–5.0 cm; 18 Fr 0.8–5.0 cm; 20 Fr 0.8–4.0 cm; 24 Fr 1.5–5.0 cm.
• Balloon inflation with sterile/distilled water: 12 Fr 3 mL (max 5 mL); 14–24 Fr 5 mL (max 10 mL).

Kit components (ENFit configuration)

• 1 MIC-KEY Low‑Profile G‑tube (ENFit configuration).
• 1 Continuous‑feed extension, 12 in/30 cm, right‑angle SECUR‑LOK with Y‑connector (medication port), ENFit feeding connector, clamp, and closure cap.
• 1 Bolus‑feed extension, 12 in/30 cm, straight SECUR‑LOK with ENFit feeding connector and clamp.
• 1 × 6 mL Luer Slip syringe (balloon inflation/deflation).
• 1 × 35 mL ENFit enteral feeding syringe.
• Gauze pads (pack of four).
• Insertion stylet and water‑soluble lubricant: included in some regions; availability varies.

Contraindications (include but not limited to)

• Ascites, colonic interposition, portal hypertension, peritonitis, morbid obesity.

Storage and shelf life

• Store in a cool, dry place away from heat and radiation. Typical shelf life is 2 years from date of manufacture.

Manufacturing and regulatory

• Manufactured in Mexico under an ISO 13485‑compliant quality system; CE‑marked where applicable.

Notes

• This listing is for the ENFit configuration of the MIC-KEY G‑tube; information for gastro‑jejunal devices does not apply.
• Regional kit contents and available stoma lengths may vary; verify local listing before selection.