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Description
A skin-level, low-profile balloon gastrostomy button designed for long-term enteral feeding, gastric decompression, and medication delivery into the stomach. The device sits flush to the skin to reduce profile and snag risk, and incorporates an internal silicone retention balloon and a proximal anti-reflux valve that closes when the extension set is removed. The SECUR-LOK patient-end interface provides a secure connection to dedicated extension sets, while ENFit connectivity (ISO 80369-3) on the feeding side standardizes enteral-only connections.
Key Features
- Low-profile “button” made of high-clarity, medical-grade silicone
- Proximal anti-reflux valve to help minimize backflow when disconnected
- SECUR-LOK patient-end connector with alignment marks; three-quarters turn to lock
- Tapered distal tip; recessed tip at recommended fill volume for comfort
- Radiopaque stripe for visualization
- Not made with natural rubber latex; not formulated with DEHP
Sizes and Balloon Fill
- French sizes: 12, 14, 16, 18, 20, 24 Fr
- Stoma lengths (cm): 0.8–5.0 depending on size; 12 Fr (0.8–4.0), 14–20 Fr (0.8–5.0), 24 Fr (1.5–5.0)
- Balloon fill (sterile or distilled water only): 12 Fr 3 mL (max 5 mL); 14–24 Fr 5 mL (max 10 mL)
Connectivity and Extension Sets
- Compatible with MIC-KEY extension sets featuring SECUR-LOK patient-end connectors
- ENFit ports (ISO 80369-3) on feeding side; ENFit syringes interface with ENFit ports
- Balloon port accepts a Luer-slip syringe
- Common sets: right-angle continuous-feed Y-port and bolus sets (straight or right-angle); typical lengths 2 in (5 cm), 12 in (30 cm), 24 in (60 cm)
- Extension sets: non-sterile, reusable for a single patient; not made with natural rubber latex; DEHP-free
Kit Contents (typical ENFit configuration)
- Low-profile G-tube
- 12 in (30 cm) continuous-feed ENFit right-angle Y-port extension
- 12 in (30 cm) ENFit bolus extension (straight or right-angle)
- 6 mL Luer-slip syringe (balloon)
- 35 mL ENFit enteral syringe
- Gauze pads (4)
- In some regions: insertion stylet and water-soluble lubricant
- Not included: stoma measuring device
Materials
- Tube: silicone; polyether imide; polycarbonate; barium sulfate; stainless steel spring
- Extension sets: PVC (citrate plasticizer) and ABS; clamp polypropylene
Indications and Contraindications
- Indications: long-term enteral feeding, gastric decompression, direct gastric medication delivery; initial placement under fluoroscopic, laparoscopic, or endoscopic guidance, or replacement in a mature tract
- Contraindications (for placement): ascites, colonic interposition, portal hypertension, peritonitis, morbid obesity
Sterility and Regulatory
- G-tube sterilized by ethylene oxide; single-use
- CE marked; manufacturer quality system ISO 13485 compliant
- Manufactured in Mexico
Packaging, Storage, and Shelf Life
- Individual sterile hard tray; one tray per carton
- Store in a cool, dry place away from heat and radiation
- Shelf life: 2 years from date of manufacture
