Description

Intended Use

• Balloon-retained, single-lumen gastrostomy tube intended for bolus feeding in adult and pediatric patients requiring long-term enteral nutrition.
• Also suitable for gastric decompression and for direct medication delivery when oral intake is not possible and aspiration risk is low.

Design and Construction

• High-clarity, medical-grade silicone tube with an internal silicone retention balloon.
• External SECUR-LOK silicone stabilization ring/disc for external fixation and position control.
• Radiopaque stripe (barium sulfate) with centimeter markings for placement verification and ongoing monitoring.
• Distal tip is recessed at the recommended balloon fill; 12 Fr size features a tapered tip.
• Approximate overall tube length: 20 cm (standard long tube, non–low-profile).

Ports and Connectivity

• One ENFit gastric feeding port.
• Separate balloon inflation/deflation port labeled “BAL”.
• No separate medication port and no jejunal port.

Sizes and Balloon Fill Guidance

• 12 Fr: 2–3 mL
• 14 Fr: 3–5 mL
• 16 Fr: 3–5 mL
• 18–24 Fr: 7–10 mL
• Note: Some materials cite nominal balloon volumes of 5 mL (12 Fr) and 7–15 mL (14–24 Fr). Follow the device IFU for exact, size-specific balloon fill volume and fill only with sterile or distilled water.

Placement and Handling

• May be placed surgically, percutaneously under fluoroscopic or endoscopic guidance, or used as a replacement through an established stoma tract.
• Supplied gamma-sterile; single-use only. Do not re-use, re-process, or re-sterilize.
• Prescription use only (Rx only).

Materials and Safety

• MR Safe.
• Not formulated with natural rubber latex, DEHP, DBP, or BBP.

Regulatory and Manufacturing

• Manufacturer: Avanos Medical.
• Manufactured in Mexico; manufacturing site quality system compliant with ISO 13485.
• CE marked under 93/42/EEC, Class IIb; Notified Body: BSI (2797).

Storage and Shelf Life

• Store in a cool, dry place away from heat and radiation sources.
• Shelf life: 3 years from date of manufacture.

Contraindications (related to gastrostomy placement)

• Ascites
• Colonic interposition
• Portal hypertension
• Peritonitis
• Morbid obesity

Packaging

• Each tube is provided gamma-sterile in an individual Tyvek pouch.

Notes

• Applies to the MIC ENFit Balloon Gastrostomy Tube (Bolus) configuration; details for MIC/MIC-KEY jejunal or gastric-jejunal tubes are excluded.