UreSil’s Gravity Drainage Bags are made from a high quality plastic film, provide reliable collection, and have become one of the most widely purchased gravity bag products for interventional drainage.

The TC600 comes with a 600ml drainable collection bag, 20″ of stretchable tubing, a luer lock connector, a loop belt and an elastic hook.

INTENDED USE: For collecting drainage fluids. The Gravity Drainage Bags are intended to be used to collect fluids drained from abscesses, the hepatic system, and the kidneys. This product is intended for shortterm use (less than 30 days). Replace bag every 5 to 7 days or sooner if clinically indicated, for example, if malodorous or damaged.

INTENDED PATIENT POPULATION: This product is intended to be used with patients with placed drainage catheters.

CLINICAL BENEFITS: The Gravity Drainage Bags are available in a variety of sizes and configurations. They can attach to any standard luer locking drainage catheter and can remove fluids using gravity. Additional clinical benefits:

• Simple and intuitive to operate.
• Compact and self-contained system allows full patient ambulation.
• Closed system design reduces the chances of cross-contamination.
• Anti-reflux valve prevents liquids and air from backing up into the catheter.
• During activation, body fluids are not aerosolized because all fluids are contained in the system.

PERFORMANCE CHARACTERISTIC: Gravity Drainage Bags have an inlet tube with a luer lock fitting for connection to a standard luer lock drainage catheter, anti-reflux valve, empty port and Velcro belt system. Flow to the bag occurs via gravity drainage as long as the bag is below the level of the drainage site.

ACCESSORIES TO BE USED WITH THE DEVICE: The PDC-36 Percutaneous Drainage Catheter Connector Tubing is comprised of an inlet tube with a luer connector and is used for connecting a percutaneous catheter to a drainage bag or system. The TCY2 “Y” Connector Tubing Set is comprised of an inlet tube with a luer connector and a “Y” connector and is used for bilateral drainage with a gravity-drainage or suction-drainage system. UFA-LL is comprised of a tapered funnel and a female luer connector and is used to connect UreSil Ulti-flo Large Bore non-locking catheters (REF LBNL-series) to a standard luer.

INSTRUCTIONS FOR USE:

• Close the port prior to use.
• Thread the belt as shown.
• Connect the drainage catheter to the bag tubing as shown.
• If altering the bag tube length, using sterile technique, remove the luer lock, cut the tubing and re-attach the luer lock.
• Suspend the bag at a location below the drainage site as shown.
• Replace bag every 5 to 7 days or sooner if clinically indicated, for example, if malodorous or damaged.

CAUTION:

• Use care if emptying bag to avoid contact with drained fluids.
• Consult a healthcare professional if no fluid is draining into the bag or if fluid is leaking from the bag.

CONTRAINDICATIONS: Currently no specific contraindications are known for the Gravity Drainage Bags.

WARNING: The reuse of this single-use device can lead to patient infection and/or device malfunction. Sterile if package is unopened and undamaged. Do not use if the sterile package is damaged or is unintentionally opened before use.

SAFE DISPOSAL: Dispose of used device in container marked for biohazard (i.e. contaminated with potentially infectious substances of human origin).

REPORTING SERIOUS INCIDENTS: Any serious incident that has occurred in relation to the device should be reported to UreSil as the manufacturer and the Competent Authority of the Member State in which the user and/or patient is established.