Description
The Avanos MIC-KEY Low-Profile Balloon Gastrostomy Button (G-Tube) with ENFit extension sets is a skin-level enteral access device for long-term nutritional support, medication delivery, and gastric decompression. It is intended for enteral use only and is suitable for pediatric through adult patients. The internal inflatable retention balloon and external base provide secure placement, while the low-profile “button” reduces external bulk and snagging in daily activities.
Key design features
- Low-profile, discreet button that sits at skin level to help reduce accidental pulling.
- Feeding port with anti-reflux valve that remains closed when no extension set is attached.
- SECUR-LOK patient-end connector interface with alignment marks; locks with a clockwise turn to attach MIC-KEY extension sets.
- Radiopaque stripe for visibility under imaging.
- Extension set port cover to cap when not in use.
Materials and safety
- High-clarity, medical-grade silicone construction with silicone balloon.
- Not made with natural rubber latex and not made with DEHP as a plasticizer.
- Sterilized with ethylene oxide (EO).
- Single-use device: do not reuse, reprocess, or resterilize; do not use if package is damaged.
- MR Conditional (tested for use in MRI environments at 1.5 T and 3 T within specified conditions).
- Rx only (where applicable).
Connectors and compatibility
- Connects to MIC-KEY extension sets that provide ENFit enteral-only connections to feeding sets and ENFit syringes.
- Use only MIC-KEY brand extension sets with MIC-KEY buttons; brand-specific extensions are not interchangeable.
Kit contents (ENFit configuration)
- MIC-KEY Low-Profile G-Tube with balloon valve, extension-set port and cover, and external base.
- Two ENFit extension sets (approximately 12 in/30 cm):
- Continuous feed extension: SECUR-LOK right-angle patient-end; 2-port Y with medication port; integrated tubing clamp.
- Bolus feed extension: straight connector.
- ENFit enteral syringe and a Luer slip syringe for balloon inflation/deflation.
- Gauze pad; insertion stylet; water‑soluble lubricant. (Stoma measuring device not included.)
Sizes and length options
- French sizes (OD): 12, 14, 16, 18, 20, 24 Fr.
- Stoma lengths (cm): 0.8, 1.0, 1.2, 1.5, 1.7, 2.0, 2.3, 2.5, 2.7, 3.0, 3.5, 4.0, 4.5, 5.0.
- Example variant: 20 Fr diameter with 3.0 cm stoma length.
Balloon fill guidance
- Inflate with sterile or distilled water only (do not use air, saline, or contrast).
- 12 Fr: recommended 3 mL (maximum 5 mL).
- 14–24 Fr: recommended 5 mL (maximum 10 mL).
Extension set details
- Continuous feed extension length: 30 cm (≈12 in).
- Non-sterile; reusable for single-patient use only; latex-free; DEHP-free formulation.
- Includes SECUR-LOK right-angle patient-end, ENFit connections, two-port Y with medication port, and integrated clamp.
Handling highlights
- Measure the stoma to select the correct shaft length; verify balloon integrity and tube placement per IFU.
- Flush the feeding tube and extensions with water before and after feeds and medications; use liquid medications when possible.
- Check balloon water volume periodically per IFU to maintain retention.
Contraindications (per device IFU context)
- Examples include ascites, colonic interposition, portal hypertension, peritonitis, and morbid obesity (clinical judgment required).