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The Enteral Drainage System is intended to allow the evacuation of excess gas and drainage of gastrointestinal fluids from patients utilizing an enteral device. The Enteral Medicine Straw is intended for drawing and delivery of medicine to patients through an ENFit syringe.

The Enteral Drainage System and the Enteral Medicine straw are intended to be used during enteral nutrition treatments in combination with enteral feeding tubes, syringes and other compatible enteral medical devices. The Enteral Drainage System is intended to allow the evacuation of excess gas and drainage of gastrointestinal fluids from patients utilizing an enteral device. The device consists of: - a bag in DEHP FREE PVC, equipped with a hydrophobic 3μm filter to allow gas escape; - two short PVC tubes (5-6 cm) on top and bottom of the bag; the bottom one is equipped with a male enteral connector, and the top one with a female enteral connector that is capped off with an ENFit-compatible cap; - a clamp to regulate the fluid flow, placed over the bottom tube. It is available in five sizes, depending on the volume of the bag included in the device: - MED50LU, Enteral drainage bag 50 ml; - MED100LU, Enteral drainage bag 100 ml; - MED250LU, Enteral drainage bag 250 ml; - MED500LU, Enteral drainage bag 500; - MED1000LU, Enteral drainage bag 1000 ml. The device is connected to the nasogastric or naso-jejunal feeding tube between feeding sessions to allow the drainage of stomach or intestinal fluids and gasses in excess. The transparency of the materials allows for constant monitoring and visualization of drained fluids. The bag must be placed at a lower level than the patient's stomach and also acts as a venting device. The Enteral Medicine straw, coded C005LU, is intended for drawing and delivery of medicine to patients through an ENFit enteral syringe. It consists of a male enteral connector (that allows the connection to a compatible enteral syringe) and a tubing in thermoplastic polyurethane. Once the fluid is drawn up from the container into the syringe, the cannula must be disconnected, and the syringe can then be connected to another medical device (normally, a feeding tube or a gastrostomy tube) to administer its content to the patient. All enteral connections of the subject devices are designed to avoid for inadvertent delivery of enteral feedings through the intravenous route. i.e., the devices cannot be connected to devices endowed with a luer connector. The devices are sterilized with Ethylene Oxide (EtO). These devices are targeted to neonatal, pediatric and adult patients, with compromised or limited gastric motility; they are for single patient use and can be reused multiple times within a twenty-four-hour period, after which they are to be replaced.