Description

The Avanos MIC ENFit Balloon Gastrostomy Tube – Bolus style is a single‑lumen, balloon‑retained G‑tube for pediatric and adult patients who cannot tolerate oral intake and are at low aspiration risk. It is intended for bolus enteral feeding, gastric decompression/venting, and direct medication delivery to the stomach.

Key features

• High‑clarity, medical‑grade silicone tube with internal silicone retention balloon
• Recessed distal tip when balloon is filled; 12 Fr features a tapered tip
• Radiopaque stripe for X‑ray visualization and centimeter markings on the shaft
• Adjustable SECUR‑LOK external stabilization ring/disc
• Standard tube length approximately 20 cm

Connectors and ports

• One ENFit gastric feeding port (single‑lumen bolus configuration)
• Separate balloon inflation/deflation port labeled “BAL”
• No separate medication port; no jejunal port

Sizes and balloon fill guidance

• 12 Fr: fill 2–3 mL (LV nominal ~5 mL)
• 14 Fr: fill 3–5 mL (LV nominal ~7 mL)
• 16 Fr: fill 3–5 mL (LV nominal ~7 mL)
• 18 Fr: fill 7–10 mL (standard nominal ~15 mL)
• 20 Fr: fill 7–10 mL (standard nominal ~15 mL)
• 22 Fr: fill 7–10 mL (standard nominal ~15 mL)
• 24 Fr: fill 7–10 mL (standard nominal ~15 mL)

Balloon inflation medium: sterile or distilled water only. Do not use air, saline, or contrast. For LV balloons, do not exceed 7 mL total; for standard balloons, do not exceed 15 mL total. Always follow the IFU and the volume printed on the device label.

Placement and use

• May be placed surgically or percutaneously under fluoroscopic or endoscopic guidance
• Suitable as a replacement tube through an established tract
• Position the SECUR‑LOK ring approximately 1–3 mm above the skin; verify position daily

Safety and composition

• MR Safe
• Not made with natural rubber latex, DEHP, DBP, or BBP
• For enteral feeding/medication delivery only

Sterility and regulatory

• Supplied gamma‑sterile; single‑use only. Do not reuse, reprocess, or resterilize. Do not use if the package is damaged. Prescription use only.
• Manufacturer: Avanos Medical; manufactured in Mexico; quality system compliant with ISO 13485
• CE marked medical device under 93/42/EEC, Class IIb (Notified Body BSI 2797)

Storage and shelf life

• Store in a cool, dry place away from heat and radiation sources
• Shelf life: 3 years from date of manufacture (per labeling)

Contraindications for gastrostomy tube placement (general)

• Ascites
• Colonic interposition
• Portal hypertension
• Peritonitis
• Morbid obesity

Packaging and labeling

• Each tube is supplied gamma‑sterile in an individual Tyvek pouch
• One sterile pouch per carton; five cartons per shipping case
• Unit and carton include linear barcodes
• Labeling indicates French size and recommended balloon volume on the balloon port