Description

The 16Fr ENFit MIC Gastric-Jejunal Tube is a specialized medical device crafted from medical-grade silicone, designed to meet the complex nutritional needs of both pediatric and adult patients. This device serves a dual purpose: providing effective gastric decompression and facilitating enteral nutrition delivery directly into the distal duodenum or proximal jejunum.

Key Features

• ENFit® Connector: Ensures secure and standardized connections, enhancing patient safety.
• Multiple Length Options: Jejunal feeding port available in 15 cm, 22 cm, 30 cm, and 45 cm lengths to accommodate various clinical needs.
• Radiopaque Stripe: Allows for clear visualization under imaging, aiding in accurate placement.
• Tungsten-Weighted Jejunal Portion: Facilitates easy placement, reducing the need for additional interventions.

Design and Construction

The tube features a tapered distal tip for non-traumatic insertion and multiple exit ports to improve flow and minimize clogging. Its construction includes a SECUR-LOK™ external retention ring and an internal inflatable silicone retention balloon, ensuring secure fixation with adjustable fill volumes.

Indications for Use

This device is particularly beneficial for patients with conditions such as:

• Intestinal motility disorders
• Gastric outlet obstruction
• Severe gastroesophageal reflux
• Post-operative needs following esophagectomy or gastrectomy

Additional Specifications

• Outer Diameter: 16 French (Fr)
• Separate Jejunal and Gastric Ports: Allows for distinct management of feeding and drainage.
• Sterilization: Available through ethylene oxide or gamma methods, ensuring high standards of hygiene.

Placement and Compatibility

The tube can be placed surgically, endoscopically, radiologically, or as a replacement for an existing enteral feeding tube. It is compatible with the AVANOS Gastrointestinal Anchor Set with SAF-T-PEXY T-Fasteners for primary placement, offering flexibility in clinical settings.

Kit Contents

The kit includes essential components such as a silicone-coated guide wire, abdominal trocar, syringes, and povidone iodine USP. Note that international kits may vary in contents.

Packaging

Each unit is individually packaged with dimensions approximately 50.8 x 34.29 x 5.588 cm and a weight ranging from 0.474 to 0.737 kg. The product is manufactured in the USA by Kimberly-Clark / Avanos Medical, reflecting a commitment to quality and precision.

Regulatory Information

The 16Fr ENFit MIC Gastric-Jejunal Tube is FDA approved and intended for prescription use only, underscoring its role as a trusted solution in advanced patient care management.