Description

Balloon‑retained, single‑lumen, medical‑grade silicone jejunal feeding 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 and for prescription use only.

Key Features

• ENFit male connector labeled “Jejunal” for feeding and medication delivery
• Separate white “BAL” port for balloon inflation/deflation; not for medication administration
• Internal silicone retention balloon with SECUR‑LOK adjustable external retention ring for stabilization
• Radiopaque stripe along the tube for imaging visualization
• Trimmable distal tip and centimeter markings to aid individualized placement
• Latex‑free and plasticizer‑free (no DEHP, DBP, BBP)
• MRI‑safe
• Sterile; gamma sterilized; single‑use

Intended Use and Placement

• Provides jejunal access for enteral nutrition and medications when gastric feeding is not appropriate
• Placement through an established gastric stoma via endoscopic, radiologic (fluoroscopic), or surgical techniques
• Suitable for replacement through a mature stoma tract

Specifications

• Jejunal length: 51 cm (measured from distal aspect of the retention balloon to the tip); distal end may be trimmed
• 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/connectors: Single jejunal feeding port; medications may be delivered via the jejunal port
• External retention: SECUR‑LOK external retention ring

Materials and Safety

• Tube and balloon: medical‑grade silicone with radiopaque stripe
• Not made with natural rubber latex; not made with DEHP/DBP/BBP
• MRI‑safe
• Sterile, single‑use device; do not reuse, reprocess, or resterilize

Packaging and Regulatory

• Individually pouched; manufacturer carton contains 2 units
• Manufacturer: Avanos Medical, Inc. (MIC brand); manufactured in Mexico; ISO 13485 compliant facility
• CE marked under Directive 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; single‑use device
• The BAL port is solely for balloon management; do not administer fluids or medications via the BAL port