Description
A balloon‑retained, single‑lumen jejunal feeding tube designed to deliver enteral nutrition and medications to the distal duodenum/proximal jejunum when gastric feeding is unsuitable. Intended for placement through an established gastric stoma and compatible with ENFit connections.
Intended use and clinical examples
- Inadequate gastric absorption
- Intestinal motility disorders
- Gastric outlet obstruction
- Severe gastroesophageal reflux disease (GERD)
- Aspiration risk
- Post upper‑GI surgery (e.g., esophagectomy, gastrectomy)
Design and key features
- Medical‑grade silicone tube with internal silicone retention balloon
- Jejunal feeding port with ENFit connector labeled “JEJUNAL”
- Separate white “BAL” port for balloon inflation/deflation
- SECUR‑LOK adjustable external retention ring for skin‑level stabilization
- Radiopaque stripe and centimeter markings to assist with placement verification and monitoring external length
- Trimmable tube length; tapered distal tip (where applicable)
- Not made with natural rubber latex; not formulated with DEHP, DBP, or BBP
- MRI‑safe
- Sterile, single‑use; prescription only
Specifications
- Jejunal length: 51 cm (measured from the distal aspect of the retention balloon to the tip)
- Available sizes: 12, 14, 16, 18, 20, 22, 24 Fr
- Balloon fill volumes: 12 Fr: 2–3 mL; 14–24 Fr: 7–10 mL
- Ports: Jejunal feeding port only (no dedicated medication port; medications may be administered via the jejunal port)
- Connector: ENFit
- External retention: SECUR‑LOK ring
Placement
- Through an established gastric stoma using endoscopic, radiologic (fluoroscopic), or surgical techniques
- May be used as a replacement tube through an existing mature tract
Regulatory and manufacturing
- Manufacturer/brand: Avanos Medical, Inc. (MIC)
- Manufactured in Mexico at an ISO 13485‑compliant facility
- CE marked under Directive 93/42/EEC; Class IIb; Notified Body: BSI (0086)
- Rx only
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 when practicable
Contraindications and precautions
- Contraindications include, but are not limited to: ascites, colonic interposition, portal hypertension, peritonitis, morbid obesity
- Single‑use device; do not reuse, reprocess, or resterilize