Description

Overview

Balloon‑retained, single‑lumen jejunal feeding tube made of medical‑grade silicone, designed for jejunal‑only enteral access. An internal silicone retention balloon and SECUR‑LOK external retention ring provide stabilization. The ENFit male feeding connector is labeled “Jejunal,” and a separate white balloon inflation/deflation port is labeled “BAL,” with the French size printed on the BAL port. A radiopaque stripe and centimeter markings aid visualization and depth tracking, and the distal tip is trimmable to accommodate patient needs per clinical practice.

The device features a jejunal‑only feeding lumen (no dedicated medication port). Medications may be administered via the jejunal feeding port according to clinical protocols.

Intended Use

For delivery of enteral nutrition and medications into the distal duodenum or proximal jejunum when gastric feeding is unsuitable, including inadequate gastric absorption, intestinal motility disorders, gastric outlet obstruction, severe gastroesophageal reflux/aspiration risk, or following upper‑GI surgery (e.g., esophagectomy, gastrectomy).

Placement

Inserted through an established gastric stoma via endoscopic, radiologic (fluoroscopic), or surgical methods; can be replaced through an existing stoma tract.

Key Specifications

• Jejunal length: 51 cm (measured from distal aspect of retention balloon to tip)
• Sizes: 12, 14, 16, 18, 20, 22, 24 Fr
• Balloon fill volumes: 12 Fr = 2–3 mL; 14–24 Fr = 7–10 mL
• Ports/connectors: single jejunal feeding port (ENFit male) + separate balloon inflation port (BAL)
• External retention: SECUR‑LOK adjustable retention ring
• Markings: radiopaque stripe and centimeter graduations; trimmable distal tip

Materials and Safety

• Medical‑grade silicone tube and balloon; latex‑free; DEHP/DBP/BBP‑free
• Sterile; gamma sterilized; MRI‑safe
• Single‑use; prescription only (Rx); do not reuse, reprocess, or resterilize

Packaging and Regulatory

• Individually pouched sterile device
• Manufacturer: Avanos Medical, Inc. (MIC); manufactured in Mexico; site QMS compliant with ISO 13485
• 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/radiation; keep in original packaging until use

Contraindications

Typical for jejunal/gastrostomy tract access: ascites, colonic interposition, portal hypertension, peritonitis, and morbid obesity.