Description
The AMT MiniONE® Balloon Button 14Fr 5.0cm is a specialized medical device crafted by Applied Medical Technology, designed to provide reliable gastric access for patients requiring long-term enteral feeding, medication administration, or gastric decompression. This low-profile gastrostomy tube (G-tube) is suitable for both adults and children, offering a discreet and comfortable solution for those unable to tolerate oral feeding.
Key Features
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Size and Design: With a French size of 14Fr and a stoma length of 5.0 cm, the device features an internal apple-shaped balloon for secure placement. The balloon can be easily inflated or deflated, facilitating straightforward insertion and removal.
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External Bolster: The flat, soft, and flexible external bolster sits flush against the skin, providing comfort and discretion. Its design minimizes trauma and enhances the seal at the stoma site, while being 30–37% lower in profile compared to standard designs.
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Material: Constructed from medical-grade silicone, the tube, balloon, and shaft are radiopaque for imaging purposes. The barium silicone bolster further enhances visibility.
Connectivity and Compatibility
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Connector: Equipped with an ENFit® connector, the device reduces the risk of enteral misconnections and complies with FDA and ISO standards.
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Balloon Fill Valve: Compatible with Luer (slip tip) and Luer Lock syringes, enhancing versatility for 12-14Fr devices.
Special Features
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Glow Green™: This feature aids in nighttime feeding.
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Kit Components: Includes gauze pads, syringes, lubricating jelly, extension set, bolus feeding components, and more, all provided sterile for single patient use.
Intended Use and Maintenance
The AMT MiniONE® Balloon Button is ideal for use in healthcare facilities, hospitals, and home care settings. Regular flushing is recommended to prevent blockage, and periodic balloon replacement may be necessary due to leakage or deflation.
Regulatory Information
Classified as a Class II medical device, it is exempt from premarket notification under FDA regulation 876.5980. Performance testing covers various aspects such as flow rate, balloon performance, leakage, and more, ensuring high standards of quality and reliability.
This comprehensive design makes the AMT MiniONE® Balloon Button a versatile and dependable choice for maintaining effective gastric access in diverse care environments.
