Description
The Avanos MIC ENFit Balloon Gastrostomy Tube is a balloon‑retained, single‑lumen silicone G‑tube that provides gastric access for bolus, intermittent, or continuous enteral feeding, medication/fluids administration, venting/decompression, and free drainage/aspiration. Suitable for adult and pediatric patients, it traverses an established or newly created stoma into the stomach and is MR Safe.
Key design and materials
- Inflatable internal silicone retention balloon holds the tube within the stomach.
- External SECUR‑LOK stabilization ring/disc provides secure skin‑level support while permitting air circulation; typically positioned with ~2–3 mm clearance from skin.
- Long external tube (not low‑profile) with high‑clarity, medical‑grade silicone for visibility and drapability.
- Radiopaque barium‑sulfate stripe for imaging visibility; many sizes include centimeter shaft markings (see labeling).
- Distal tip: tapered in smaller sizes; recessed at recommended fill volume in larger sizes.
- Materials: silicone tube and balloon; connectors include Tritan. Not formulated with natural rubber latex, DEHP, DBP, or BBP.
Ports and connectivity
- ENFit gastric feeding port(s) for ENFit syringes and administration sets.
- Separate balloon inflation/deflation valve (Luer syringe interface; non‑ENFit). Do not administer feeds/medications via the balloon valve.
- Configurations:
- Bolus G‑tube: single ENFit feeding port.
- Y‑connector G‑tube: ENFit Y‑connector with separate feed and medication access into the same gastric lumen.
Sizes and configurations
- Typical French sizes: 12, 14, 16, 18, 20, 22, 24 Fr; some Y‑connector models up to ~26–30 Fr. Bolus models typically 12–24 Fr.
- Approximate tube length ~20 cm (varies by size/configuration).
- Presence of centimeter markings varies; check product labeling.
Balloon fill guidance
- Fill balloon with sterile or distilled water only (no air or saline).
- Typical volumes (refer to IFU for exact values): smaller sizes ~2–5 mL; mid sizes (e.g., 18–24 Fr) ~7–10 mL; larger Y‑connector models ~15 mL.
- Periodically verify balloon volume per IFU/care plan.
Placement and clinical use
- May be placed surgically or percutaneously under endoscopic/fluoroscopic guidance, and is suitable as a replacement tube through an established tract.
Use and care highlights
- Flush feeding lumen per care plan/IFU (after feeds and between/after medications) to maintain patency.
- Position external bolster flush but not tight; monitor external length and centimeter marks for migration.
- Avoid overtightening ENFit connections.
Contraindications (examples)
- Ascites, colonic interposition, portal hypertension, peritonitis. For replacement: uncertain or immature tract, lack of stomach adherence, peristomal infection, multiple fistulae, uncorrected coagulopathy.
Regulatory and manufacturing
- Single‑use, gamma‑sterile; do not reuse, reprocess, or resterilize. Prescription use only.
- MR Safe. Manufactured under an ISO 13485 quality system; CE marked (93/42/EEC, Class IIb). Manufactured in Mexico.
Storage and shelf life
- Store in a cool, dry place away from heat and radiation. Typical shelf life: 3 years from date of manufacture.
Safety notes
- Use only ENFit ports for feeding/medications; never use the balloon valve for administration.
- Dislodgement/displacement requires prompt clinical attention; early tracts may require position verification before reuse.