Description

A low-profile, button-style gastrostomy feeding tube, this device provides enteral delivery of nutrition and medications directly to the stomach and may be used for gastric decompression/venting. It features an internal inflatable retention balloon and a radiopaque stripe to aid radiographic confirmation of placement. Prescription use (Rx only).

Indications and Contraindications

• Indications: long-term enteral feeding when oral intake is not tolerated; patients at low risk for aspiration; gastric decompression and direct gastric medication delivery.
• Contraindications (non-exhaustive): ascites; colonic interposition; portal hypertension; peritonitis; morbid obesity.

Design and Connections

• Low-profile, skin-level external base (button) with covered port.
• Internal retention balloon; balloon valve accepts a Luer-slip syringe.
• Anti-reflux valve in the feeding port remains closed when no extension set is attached.
• SECUR-LOK connection with alignment marks; quarter‑turn/twist-to-lock to secure extension sets.
• ENFit (ISO 80369-3) enteral-only connectors on extension sets to help reduce misconnections.
• High-clarity medical-grade silicone tube with radiopaque barium sulfate stripe; not made with natural rubber latex or DEHP.
• Tube sterilized with ethylene oxide (single-use); extension sets are non-sterile and reusable for a single patient.

Sizes and Balloon Volumes

• French sizes: 12, 14, 16, 18, 20, 24 Fr.
• Stoma lengths (cm): 0.8–5.0 depending on size; typical availability: 12 Fr (0.8–4.0 cm), 14/16/18/20 Fr (0.8–5.0 cm), 24 Fr (1.5–5.0 cm).
• Balloon inflation with sterile/distilled water only: 12 Fr 3 mL recommended (max 5 mL); 14–24 Fr 5 mL recommended (max 10 mL).

Kit Contents (ENFit configuration)

• Low-profile gastrostomy feeding tube (button).
• Continuous Feed Extension Set, ENFit, 12 in, SECUR-LOK right-angle patient-end (Y connector with feeding/medication ports; closure cap and clamp).
• Bolus Feed Extension Set, ENFit, 12 in, SECUR-LOK straight patient-end (feeding/medication port; clamp).
• 6 mL Luer-slip syringe (balloon) and 35 mL ENFit enteral syringe.
• Four gauze pads; insertion stylet (US only); water‑soluble lubricant (US only).
• Not included: stoma measuring device.

Placement, Sizing, and Use

• May be placed percutaneously under fluoroscopic, laparoscopic, or endoscopic guidance; suitable as a replacement device in a mature stoma tract.
• Measure stoma depth and select a shaft length equal to the measured length; external base should rest flush to the skin (clinical practice often allows ~1–3 mm clearance).
• Button connects only to MIC-KEY extension sets; ENFit ports support continuous/pump feeding, bolus feeding, and medication delivery. Flush via the extension set; do not access the anti‑reflux valve directly.

MRI Safety (MR Conditional)

• 1.5 T or 3 T; maximum spatial field gradient ≤ 1,960 G/cm (19.6 T/m).
• Whole‑body averaged SAR < 2 W/kg (Normal Operating Mode).
• Expected maximum temperature rise < 1.3 °C after 15 minutes; artifact may extend < 45 mm at 3 T (gradient‑echo).

Cautions and Warnings

• Feeding tube: single use only; do not reuse, reprocess, or resterilize.
• Enteral use only; do not connect to IV systems.
• Inflate balloon with sterile/distilled water only; do not use air, saline, contrast media, or medications.
• Use MIC-KEY extension sets only.

Additional Note

• Silicone balloon longevity typically ranges from about 1 to 8 months, depending on care, gastric pH, and patient factors.