Description

The Avanos MIC-KEY Low-Profile Balloon Gastrostomy (G) Feeding Tube is a skin-level button designed for long-term enteral nutrition (bolus or continuous), medication delivery, and gastric decompression/venting in pediatric and adult patients. It is an enteral-only, Rx device supplied sterile (ethylene oxide) and constructed for comfort, discretion, and reliable access to the stomach.

Indications and contraindications

• Indications: long-term enteral feeding in patients unable to tolerate oral intake; appropriate for patients at low risk of aspiration; supports gastric decompression and direct gastric medication delivery.
• Contraindications (non-exhaustive): ascites, colonic interposition, portal hypertension, peritonitis, morbid obesity.

Placement and compatibility

• Placement: percutaneous under fluoroscopic, laparoscopic, or endoscopic guidance; also suitable as a replacement device via an established stoma tract.
• Connector system: the button mates only with MIC-KEY Extension Sets featuring the SECUR-LOK patient-end interface (with safety ring) that opens the anti-reflux valve and helps reduce leakage/misconnections. Included/compatible extension sets use ENFit connectors on the feeding side; syringes and administration sets should be ENFit.
• Medication access: via the ENFit Y-connector on the continuous feed set; the bolus set’s ENFit port may also be used for medication. No jejunal port (G-tube only).

Key device features

• Low-profile, skin-level button with external base and port cover.
• Internal silicone retention balloon; inflate with sterile or distilled water only.
• Feeding port with anti-reflux valve that remains closed without an extension set attached.
• Recessed/tapered distal tip at recommended fill volume; radiopaque stripe for visualization.
• High-clarity, medical-grade silicone; not formulated with natural rubber latex or DEHP.
• MR Conditional at 1.5 T and 3 T under IFU-specified conditions.

Sizes and selection

• French sizes: 12, 14, 16, 18, 20, 24 Fr.
• Shaft (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 (24 Fr typically 1.5–5.0 cm).
• Sizing note: measure stoma length and select shaft height accordingly; clinicians may add ~4–5 mm per IFU/clinical guidance.

Balloon inflation volumes (sterile/distilled water)

• 12 Fr: recommended 3 mL; maximum 5 mL.
• 14–24 Fr: recommended 5 mL; maximum 10 mL.

Extension sets included (ENFit)

• Continuous Feed Extension Set, 12 in (30 cm): SECUR-LOK right-angle patient-end; ENFit Y-connector with caps; clamp.
• Bolus Feed Extension Set, 12 in (30 cm): SECUR-LOK straight patient-end; single ENFit connector with cap; clamp.
• Extension sets are non-sterile and reusable for a single patient per IFU.

Materials, sterility, and packaging

• Tube: silicone with radiopaque barium sulfate; components may include polyetherimide, polycarbonate, and a stainless-steel spring (valve mechanism).
• Extension sets: PVC (citrate plasticizer) and ABS; polypropylene clamp. Not formulated with natural rubber latex or DEHP.
• Sterile, single-use tube; do not reuse, reprocess, or resterilize. Packaged as one sterile kit (hard tray). Manufactured under ISO 13485; CE marked (MDD) where applicable. Typical shelf life 2 years; store cool and dry away from heat/radiation.

Kit contents (typical)

• MIC-KEY Low-Profile G-tube (button)
• Two ENFit extension sets (continuous Y/right-angle and bolus/straight), each 12 in, with clamps
• 6 mL luer slip syringe (balloon inflation/deflation)
• 35 mL ENFit enteral syringe (priming/flushing/bolus feeding)
• Gauze pads; MIC-KEY insertion stylet; water-soluble lubricant (availability may vary). Stoma measuring device not included.

Use and handling notes

• Use ENFit-to-ENFit connections to avoid misconnections. Flush per IFU and check balloon volume periodically. Verify package integrity before use and follow clinician/IFU instructions for placement, care, and replacement.

Example configuration

• 18 Fr, 3.5 cm shaft length; recessed distal tip; radiopaque stripe; includes both ENFit extension sets; recommended balloon fill 5 mL (max 10 mL); no jejunal port.