Description

The Avanos MIC ENFit Balloon Gastrostomy Tube is a standard-length, balloon‑retained G‑tube designed to provide reliable access to the stomach for long‑term enteral feeding, gastric decompression/venting, and direct medication delivery in adult and pediatric patients at low aspiration risk. It is the standard‑length MIC tube and is not a low‑profile MIC‑KEY button.

Intended use and patient selection

• Indications: Long‑term enteral nutrition when oral intake is not possible or not tolerated; gastric decompression; direct gastric medication delivery.
• Contraindications for gastrostomy placement include ascites, colonic interposition, portal hypertension, peritonitis, and morbid obesity.

Design and materials

• Soft, medical‑grade silicone construction with a radiopaque (barium sulfate) stripe and centimeter markings for placement verification and monitoring external length.
• Internal silicone retention balloon with an adjustable SECUR‑LOK external stabilization ring/disc, typically positioned about 2–3 mm above the skin.
• Recessed distal tip at the recommended balloon fill (12 Fr sizes typically tapered). Approximate tube length ~20 cm, varying by size/configuration.
• MRI: MR Safe.
• Biocompatibility: Not made with natural rubber latex; not formulated with DEHP/DBP/BBP.

Ports and connectivity

• ENFit gastric port options:
• Single gastric lumen (bolus configuration; no separate medication port).
• Version with an additional ENFit medication port to help separate feeds, medications, and flushes.
• Balloon inflation port labeled BAL for inflation/deflation; accepts a Luer‑slip syringe.
• ENFit design provides enteral‑only connectivity; extension sets are not required for this standard‑length tube.

Sizes and balloon fill guidance

• Typical French sizes:
• Single‑lumen (bolus): 12, 14, 16, 18, 20, 22, 24 Fr.
• With medication port: commonly 12 up to 30 Fr (availability varies by size/model).
• Fill balloon with sterile or distilled water only; do not use air, saline, or contrast.
• Typical balloon fill ranges (refer to device/IFU for exact volume; do not exceed maximum):
• 12 Fr: 2–3 mL
• 14–16 Fr: 3–5 mL
• 18–26 Fr: 7–10 mL

Placement and environments of use

• Placement: Surgical; percutaneous under fluoroscopic or endoscopic guidance; or replacement through an established stoma tract.
• Settings: Hospital, long‑term care, and home care.

Important use notes

• Stabilize the tube during balloon inflation/deflation to prevent dislodgement.
• Verify and maintain balloon volume per IFU; refill as needed to the prescribed volume.
• Cap ports when not in use.

Sterility and regulatory

• Single‑use; gamma‑sterile. Do not reuse, reprocess, or resterilize. Do not use if packaging is damaged. Prescription use only (Rx).
• Manufacturer: Avanos Medical. Manufacturing site ISO 13485 compliant; made in Mexico.
• Regulatory: 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. Typical shelf life: 3 years from date of manufacture.

Potential complications

• Possible events include skin breakdown, hypergranulation tissue, gastric/duodenal ulceration, infection, and pressure necrosis.

Clarification

• This is the standard‑length MIC ENFit Balloon Gastrostomy Tube. It does not require MIC‑KEY extension sets and does not include the low‑profile anti‑reflux feed port found on MIC‑KEY button devices.