danumed Extension Set for Gastrostomy Button
Danumed Medizintechnik GmbH
FDA Clearance Information
FDA-Cleared Indications
- For use with compatible gastrostomy buttons to provide access for enteral feeding, hydration, and administration of medication.
- Intended for patients who require enteral access through an established gastrostomy.
- For connection to enteral delivery systems using gastrointestinal tubes with enteral-specific connectors.
Clinical Applications
- Connecting an established gastrostomy button to an enteral feeding pump or feeding bag.
- Administering liquid nutrition or fluids through a gastrostomy button.
- Administering compatible liquid medications through a gastrostomy button.
- Providing temporary extension tubing during routine gastrostomy-button feeding or medication administration.
Practical Considerations
- Use only with a compatible gastrostomy button and enteral-specific connection system; confirm connector fit before use.
- Select the appropriate extension-set configuration and length for the patient's button, feeding equipment, and care setting.
- Flush the extension set as directed to help maintain patency and reduce clogging, especially after medications or thick formulas.
- Inspect for leaks, cracks, blockage, or damaged connectors before use, and follow the manufacturer's instructions for cleaning, reuse, and replacement.
- MRI safety should be confirmed from the current manufacturer labeling; do not assume the extension set is MR safe or MR conditional without documentation.
Procedures that use this device
Frequently Asked Questions
What is the danumed Extension Set for Gastrostomy Button used for?
It connects a compatible gastrostomy button to enteral feeding equipment or a syringe for delivery of nutrition, fluids, and compatible liquid medications into the stomach.
Is the danumed Extension Set for Gastrostomy Button MRI safe?
MRI safety is not established from the device information provided. Check the manufacturer's current labeling and tell the MRI team that the extension set is present before an MRI examination.
What sizes does the danumed Extension Set for Gastrostomy Button come in?
The available sizes and lengths depend on the product configuration and compatible gastrostomy-button system. Confirm the required size and connector type with the device labeling or supplier.
How long does a gastrostomy-button extension set last?
The replacement interval depends on the manufacturer's instructions, institutional policy, cleaning method, and the condition of the tubing. Replace it sooner if it becomes damaged, blocked, contaminated, or develops a leaking connection.
How much does the danumed Extension Set for Gastrostomy Button cost?
Cost varies by supplier, configuration, insurance coverage, and whether it is supplied as part of a gastrostomy-button system. Ask the prescribing clinician, durable medical equipment supplier, or insurer for the current price and coverage.