Description
A low-profile, skin-level gastrostomy button designed for long-term enteral feeding, medication delivery, and gastric decompression in pediatric and adult patients. This MIC-KEY device from Avanos Medical features an internal inflatable balloon for retention and a radiopaque stripe for visualization. It may be placed percutaneously under fluoroscopic, laparoscopic, or endoscopic guidance, or used as a replacement in a mature tract.
Key design features
- Internal balloon-retained G-tube with tapered, recessed distal tip at recommended fill volume
- Anti-reflux valve in the feeding port; opens only when a MIC-KEY extension set is properly engaged
- Low-profile external base rests slightly above the skin and allows tube rotation for care
- High-clarity, medical-grade silicone construction with radiopaque stripe
- Not made with natural rubber latex; not made with DEHP
Connectors and compatibility (ENFit)
- ENFit enteral connections (ISO 80369-3) on the feeding side
- Accepts MIC-KEY extension sets only; patient-end SECUR-LOK connector with safety ring mates to the feeding port to open/close the valve and help prevent misconnections
- Cross-compatible across MIC-KEY G, J, and GJ devices
- Connection guidance: align the black line on the connector with the MIC-KEY port, insert the “nose,” then turn clockwise to lock; keep locked during use
- Single gastric port on the button; medication access via the medication port on the ENFit Y-connector of the continuous feed extension set
Sizes and balloon inflation
- French sizes: 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
- Typical ranges: 12 Fr (0.8–4.0 cm); 14–20 Fr (0.8–5.0 cm); 24 Fr (1.5–5.0 cm)
- Balloon inflation (use sterile or distilled water; do not overinflate): 12 Fr 3 mL recommended (5 mL max); 14/16/18/20/24 Fr 5 mL recommended (10 mL max)
Kit contents (ENFit configuration)
- MIC-KEY Low-Profile G-tube (silicone, ENFit)
- ENFit Continuous Feed Extension Set with SECUR-LOK right-angle connector, Y with medication port, and clamp (commonly 30 cm/12 in)
- ENFit Bolus Extension Set with SECUR-LOK straight connector and clamp (commonly 30 cm/12 in)
- 6 mL luer-slip syringe for balloon management
- 35 mL ENFit enteral syringe
- Gauze pad(s); insertion stylet and water‑soluble lubricant may be included depending on region
Materials and sterility
- Tube: silicone with radiopaque stripe (barium sulfate); components include polyether imide, polycarbonate, and a stainless steel spring within the valve assembly
- Extension sets: PVC with citrate plasticizer and ABS; clamp typically polypropylene; non-sterile, single-patient reusable; not made with natural rubber latex; DEHP-free
- Tube is sterile (ETO sterilized)
Care and handling essentials
- Flush tube and extension sets before and after use
- Detach extension sets when not in use; wash promptly with warm, soapy water, rinse thoroughly, and air-dry
- Replace extension sets approximately every two weeks
- Use only water‑soluble lubricant; keep the feeding port/valve clean; do not inject directly into the valve
Manufacturing, regulatory, storage
- Manufactured in Mexico under an ISO 13485–compliant quality system; CE marked medical device; sterile tube is single-use
- Store in a cool, dry place away from heat and radiation; typical shelf life 2 years for the sterile kit