Description

A low-profile, balloon-retained gastrostomy button designed for long-term enteral nutrition, medication delivery, and gastric decompression in pediatric and adult patients who cannot tolerate oral intake and are at low aspiration risk. The device may be placed percutaneously under fluoroscopic, laparoscopic, or endoscopic guidance, or used as a replacement through a mature stoma tract. Supplied sterile (ETO) as a prescription device where applicable.

Design and features

• Skin-level “button” form factor to help minimize snagging; high-clarity medical-grade silicone body
• Internal inflatable retention balloon (fill with sterile or distilled water only)
• Proximal anti‑reflux valve closes when no extension set is attached
• Tapered, recessed distal tip at recommended balloon volume; radiopaque barium stripe for visualization
• Not made with natural rubber latex or DEHP
• Single gastric feeding port (no jejunal port)

Connectivity and compatibility

• Patient-end: MIC-KEY-specific SECUR‑LOK interface with alignment marks; turn to lock (up to ~3/4 turn)
• Use only MIC‑KEY G extension sets with the MIC‑KEY G feeding port
• Feeding-side on extension sets: ENFit (ISO 80369‑3); Safety Ring aids anti‑misconnection
• ENFit syringes mate to ENFit ports; medication port present on the ENFit Y of the continuous-feed extension (bolus set has no Y medication port)
• Extension sets: non‑sterile, reusable for a single patient

Sizes and balloon volumes

• French sizes: 12, 14, 16, 18, 20, 24 Fr
• Stoma lengths (size-dependent): 0.8–5.0 cm (24 Fr typically ≥1.5 cm)
• Balloon inflation: 12 Fr 3 mL recommended (max 5 mL); 14–24 Fr 5 mL recommended (max 10 mL)

Kit contents (ENFit configuration)

• Low-profile G‑tube
• Two 12 in (≈30 cm) extension sets: 1 Continuous Feed (ENFit Y with medication port; SECUR‑LOK right‑angle) and 1 Bolus Feed (ENFit; SECUR‑LOK)
• 6 mL luer slip syringe (balloon) and 35 mL ENFit enteral syringe (priming/flushing)
• Gauze pad; insertion stylet and water‑soluble lubricant included in some regions; Stoma Measuring Device not included

Materials and regulatory

• Tube: medical‑grade silicone with barium sulfate stripe; components may include polyether imide, polycarbonate, and stainless‑steel spring
• Extension sets: PVC with citrate plasticizer; connectors include ABS and polypropylene clamp
• G‑tube: single use; extension sets: reusable for single patient
• Sterilized by ETO (tube/kit); CE marked; Class IIb under MDD 93/42/EEC; manufacturer QMS to ISO 13485

Handling and care

• Connect/disconnect using alignment marks; do not overtighten; keep locked during feeding
• Flush tube and extension sets before and after use; do not inject directly into the on‑device valve
• Fill balloon with sterile/distilled water only; check volume per clinical guidance
• For MIC‑KEY G (not J or GJ), gentle 360° rotation plus 1/4 turn in the stoma may be performed per care guidance

Packaging and storage

• Typical kit carton: ~25.9 × 18.7 × 5.1 cm; ~431 g; one sterile kit per carton
• Store in a cool, dry place away from heat/radiation; keep packaged until use
• Shelf life: 2 years from date of manufacture (see labeling)

Contraindications (examples)

• Ascites, colonic interposition, portal hypertension, peritonitis, morbid obesity. Follow clinical judgment and local IFU.