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Description
The Avanos MIC ENFit Balloon Gastrostomy Tube with Y-Connector is a balloon-retained silicone G-tube designed to provide long-term gastric access for enteral nutrition, medication delivery, and gastric decompression in pediatric and adult patients who cannot tolerate oral feeding and are at low risk for aspiration. It is not a gastro-jejunal tube and contains no jejunal lumen. The device is compatible with PEG-based placement techniques.
Ports and Connectivity
- ENFit Y-connector compliant with ISO 80369-3
- Two separate gastric access ports: one for feeding and one for medications/water flushes
- Dedicated balloon inflation port
- No jejunal port
Design and Key Features
- Medical-grade silicone tube with an internal inflatable silicone retention balloon
- SECUR-LOK external retention ring (external bolster) for secure fixation and bedside adjustment of external length per protocol
- Radiopaque stripe (barium sulfate) to aid X-ray visualization
- Distal tip varies by size: 12 Fr tapered; 14–30 Fr recessed
- Separate gastric ports help organize feeding versus medication/flush workflows
Sizes and Balloon Fill Volumes
- Sizes: 12, 14, 16, 18, 20, 22, 24, 26, 28, 30 Fr
- Typical balloon fill volumes (refer to device labeling):
- 12 Fr: 2–3 mL
- 14–16 Fr: 3–5 mL
- 18–30 Fr: 7–10 mL
Placement and Compatibility
- May be placed surgically or percutaneously under fluoroscopic or endoscopic guidance
- Suitable as a replacement through an established, mature stoma tract
- PEG-placement compatible
Materials and Safety
- Materials: medical-grade silicone, Tritan, and barium sulfate radiopaque stripe
- Not formulated with natural rubber latex or DEHP/DBP/BBP
- MR Safe
- Single-use only; do not re-use, reprocess, or re-sterilize
Sterility and Regulatory
- Supplied sterile; gamma radiation sterilized
- Prescription device (Rx only)
- CE marked (EU), Class IIb (per 93/42/EEC)
Contraindications (examples, not exhaustive)
- Ascites, colonic interposition, portal hypertension, peritonitis, morbid obesity
Storage and Shelf Life
- Store in a cool, dry place away from heat and radiation sources
- Shelf life: 3 years from date of manufacture
