Description

The Avanos MIC ENFit Balloon Bolus Gastrostomy Tube is a single‑lumen, balloon‑retained G‑tube designed for bolus enteral feeding via syringe, gastric decompression, and direct medication delivery into the stomach for adult and pediatric patients who cannot tolerate oral intake and are at low risk for aspiration. It features an internal silicone retention balloon and a male ENFit gastric feeding connector; there is no separate medication or jejunal port. The device can be placed surgically or percutaneously under fluoroscopic or endoscopic guidance and may also be used as a replacement through an established stoma tract.

Connectivity and ports

• Male ENFit gastric feeding port compliant with ISO 80369‑3
• Separate balloon inflation/deflation port labeled “BAL”
• No separate medication port; medications may be delivered via the gastric feeding port per IFU and clinical protocol

Retention and securement

• Internal silicone retention balloon
• SECUR‑LOK external retention ring to maintain external position

Materials and safety

• High‑clarity, medical‑grade silicone tube and balloon
• Radiopaque barium sulfate stripe for imaging
• Connector components made from Tritan
• Not made with natural rubber latex; not formulated with DEHP, DBP, or BBP
• MR Safe

Tip and shaft features

• Recessed distal tip at recommended balloon fill for most sizes
• 12 Fr includes a tapered distal tip
• Centimeter markings on the shaft for position checks
• Nominal overall length approximately 20 cm (varies by size)

Sizes and balloon fill guidance

• 12 Fr: 2–3 mL
• 14–16 Fr: 3–5 mL
• 18–24 Fr: 7–10 mL
• Refer to the Instructions for Use (IFU) for exact fill volumes by size

Placement options

• Surgical placement, percutaneous placement under fluoroscopic or endoscopic guidance, or replacement through an established stoma tract

Sterility and single‑use information

• Sterilized by gamma radiation
• Single use only; do not re‑use, re‑process, or re‑sterilize
• Consult the IFU for additional warnings and precautions

Contraindications (not exhaustive)

• Ascites; colonic interposition; portal hypertension; peritonitis; morbid obesity

Packaging

• Sterile, individual Tyvek pouch; one pouch per unit carton; five unit cartons per shipping case
• Linear barcodes on unit and carton packaging
• Approximate packaged unit weight: ~0.204 kg

Manufacturing and quality

• Manufactured in Mexico; manufacturing site’s quality system is ISO 13485 compliant

Regulatory

• CE marked under 93/42/EEC (MDD), Class IIb; Notified Body: BSI (2797)

Storage and shelf life

• Store in a cool, dry place away from heat and radiation; keep in its dispenser box when practicable
• Shelf life: 3 years from date of manufacture