Description

Overview

Balloon-retained, single-lumen enterostomy tube designed to deliver enteral nutrition and medications into the distal duodenum or proximal jejunum when gastric feeding is unsuitable. Intended for placement through an established gastric stoma by endoscopic, radiologic (fluoroscopic), or surgical methods. Sterile, single-use, and prescription-only.

Intended use and patient selection

• For patients with poor gastric tolerance or where gastric delivery is contraindicated (e.g., intestinal dysmotility, gastric outlet obstruction, severe gastroesophageal reflux, high aspiration risk, post‑esophagectomy/gastrectomy).
• May be placed as an initial jejunal extension or used as a replacement tube through a mature stoma tract.

Design and key features

• Medical-grade silicone tube with internal silicone retention balloon.
• ENFit male connector labeled “Jejunal” feeding port; separate white “BAL” port for balloon inflation/deflation.
• Single-lumen configuration; medications may be administered via the jejunal port.
• SECUR‑LOK external retention ring allows adjustable external stabilization.
• Radiopaque stripe along tube length and centimeter markings for position reference.
• Trimmable distal tip to accommodate patient anatomy.
• Latex‑free; DEHP/DBP/BBP‑free; MRI‑safe.
• Sterile; gamma sterilized.

Specifications

• Standard jejunal length: 51 cm (measured from distal aspect of the retention balloon to tip).
• Available outer diameters: 12, 14, 16, 18, 20, 22, 24 Fr.
• Balloon fill volumes: 12 Fr = 2–3 mL; 14–24 Fr = 7–10 mL.
• Ports: ENFit jejunal feeding port plus separate balloon inflation port.
• External retention: SECUR‑LOK ring.

Materials and safety

• Tube and balloon: medical‑grade silicone; radiopaque stripe is barium sulfate‑impregnated.
• Does not contain natural rubber latex, DEHP, DBP, or BBP.
• MRI‑safe.
• Single‑use only; do not reuse, reprocess, or resterilize.

Packaging and regulatory

• Individually pouched.
• Manufacturer/brand: Avanos Medical, Inc. (MIC brand).
• Manufactured in Mexico; site quality system ISO 13485 compliant.
• CE marked under 93/42/EEC, Class IIb; Notified Body: BSI (0086).

Shelf life and storage

• Shelf life: 2 years from date of manufacture.
• Store in a cool, dry place away from heat and radiation; keep in original packaging when practicable.

Contraindications and precautions

• Contraindications include ascites, colonic interposition, portal hypertension, peritonitis, and morbid obesity.
• Prescription use only. Ensure placement and ongoing management by trained clinicians, with verification of position prior to use.