Description

The Avanos MIC-KEY Low-Profile Gastric-Jejunal (GJ) Feeding Tube Kit (ENFit) is a skin-level, double-lumen device for pediatric and adult patients who require simultaneous jejunal feeding and gastric decompression or venting. It may be placed initially (e.g., with an introducer) or used as a replacement tube in an established stoma tract.

Key Features and Design

• Low-profile button with internal inflatable silicone balloon and external bolster.
• Clearly labeled access points: JEJUNAL (feeding), GASTRIC (decompression/venting via low intermittent suction or gravity), and BAL (balloon inflation/deflation).
• One-way valves at the ports open when a MIC-KEY Extension Set is attached.
• Multiple exit ports on jejunal and gastric limbs promote flow and help minimize clogging.
• Tapered distal tip for placement.
• Radiopaque stripe and weighted, radiopaque jejunal limb to aid imaging and positioning.

Connectivity and Extensions

• ENFit connectivity for feeding and drainage interfaces.
• MIC-KEY Extension Sets attach to the button using the SECUR-LOK mechanism and feature ENFit patient-side connectors.
• No dedicated medication port; medications may be given via the jejunal or gastric lumen per clinical direction.

Validated Specifications (this kit)

• Tube outer diameter: 14 Fr
• Stoma length: 3.0 cm
• Jejunal length: 45 cm (measured from the distal aspect of the retention balloon to the catheter tip)
• Radiopaque stripe: Yes; weighted jejunal limb
• Jejunal feeding port: Yes; medication port: No
• Sterility: Sterile, gamma-irradiated; single-use; prescription device (Rx only)

Kit Contents (ENFit)

• 1 MIC-KEY low-profile GJ feeding tube
• 1 Right-Angle MIC-KEY Extension Set with double ENFit feeding connectors, closure cap, and clamp (approx. 30 cm)
• 1 MIC-KEY Bolus Extension Set with single ENFit feeding connector and straight SECUR-LOK connector (approx. 30 cm)
• 1 × 6 ml Luer-slip syringe (for balloon port)
• 1 × 35 ml female ENFit syringe
• 4 gauze pads
• 1 introducer cannula

Materials and Composition

• Tube: medical-grade silicone; polyether imide; polycarbonate; barium sulphate; stainless steel spring
• Weighted jejunal portion: tungsten
• Extension sets: PVC (citrate plasticizer) and ABS; clamp: polypropylene
• Not formulated with natural rubber latex; not formulated with DEHP/DBP/BBP

Use Notes and Cautions

• Inflate the retention balloon with sterile or distilled water only; do not use saline, tap water, or air.
• Do not rotate GJ tubes; rotation can torque the jejunal limb and cause retraction into the stomach.

Sizes and Options (Product Family)

• French sizes: 14, 16, 18, 22
• Jejunal lengths: 15, 22, 30, 45 cm (availability depends on French size/stoma length)
• Stoma lengths: approximately 1.0–7.0 cm (availability varies by size)
• Available in ENFit configuration; non-ENFit versions available separately

Packaging and Regulatory

• Selling unit: 1 kit per carton; supplied sterile in a hard-blister thermoformed tray inside a carton
• Carton dimensions (approx.): 29.8 × 23.5 × 6.7 cm; weight ~0.544 kg
• Shelf life: 2 years from date of manufacture
• Manufactured in Mexico at an ISO 13485-compliant site; CE marked (Class IIb; NB 0086)
• Storage: store in a cool, dry place away from heat and radiation