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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.

The Extension Feeding Set with ENFit™ connectors is intended for use as an extension set for a Low-Profile Gastrostomy Replacement Tube (G. Button). It is intended to provide delivery of Enteral Nutrition from administration media with ENFit™ connector and or medication into a single patient, for a maximum of two weeks. Feeding via an Extension Feeding Set is advocated when nutrition cannot be provided to the patient by mouth and therefore cannot consume an adequate number of calories because of an underlying condition.

The Extension Feeding Set with ENFit™ connectors (Extension Feeding Set), comprises a hollow tube with two different connectors at each end: an ENFit™ connector connecting to an administration media, the other is a secure lock connector for connecting to a gastric feeding device. The Extension Feeding Set is sterile, single patient use device, consisting of a polyvinylchloride tube, ABS secure lock connector, Tritan ENFit™ connector. The connectors on the proximal end of the extension sets are ENFit™ ISO 80369-3 compliant. The ENFit™ connector allows for connections of enteral specific applications while reducing the likelihood of misconnections to non-enteral devices. Extension Feeding Sets are available in three lengths: 5 cm (2"), 30.5 cm (12") or 61 cm (24"). All Extension Feeding Sets are available with either a right-angle secure lock connector or a straight secure lock connector. Both connectors are compatible with G. Button.

The Disposable Enteral Feeding Sets is intended to be used for enteral feeding nutrition into gastrointestinal tract by connecting with nasogastric tube by gravity. The devices may include a bag to contain the feeding nutrition and/or a spike to connect to a prefilled container. The device is used for children, adolescents, and adults.

The proposed device, Disposable Enteral Feeding Sets, is intended to be used for enteral feeding nutrition into gastrointestinal tract by connecting with nasogastric tube by gravity. The devices may include a bag to contain the feeding nutrition and/or a spike to connect to a prefilled container. The device is used for children, adolescents and adults. The proposed device is provided sterile or non-sterile and single use.

Mobility+ is intended to deliver liquid nutrition formula to an enteral access device (feeding tube) in users aged 2 years and over.

The Mobility+ Enteral Feeding System OTC ("Mobility+ OTC" or the "System") is a portable, lightweight, non-electronic, disposable enteral feeding system intended to deliver liquid nutrition formula to an enteral access device (feeding tube) in users aged 2 years and over in clinical or home care settings. The device is for single patient use, disposable and intended for use over a 24-hour period. The System has three primary components; food pouch, filling set and giving set. Food Pouch: The Food Pouch serves as the Mobility+ Enteral Feeding System OTC system's combined reservoir and pump. The pouch consists of a foil container with an internal elastomeric pouch. The Food Pouch can hold up to 500 ml of feed. Filling Set: The Filling Set is tubing that connects to the Mobility+ food pouch to deliver commercially available nutritional feed from its packaging to the Food Pouch using ENFit connectors. The Filling Set is used to transfer feed from the feed packaging into the Food Pouch, using a syringe. Giving Set: The Giving Set is tubing that connects the Food Pouch to the implanted feeding tube's ENFit connector. The Giving Sets will be available in a variety of lengths to give a range of feed flow rates. All connectors in the Mobility+ Enteral Feeding System OTC comply with the FDA-recognized ENFit standard (ISO 80369-3 and ISO 18250-3). The Mobility+ Enteral Feeding System OTC may be worn in a bag of choice that can fit the system without kinking the tubing and without squeezing the pouch. The instructions for use guide the user to place the spout of the pouch within 15cm (6 inches) above or below the stoma when feeding.

The ENFit to ENFit Extension Sets are intended for enteral feeding, on the order of a physician, to provide a means of delivering enteral nutrition, fluids and medications from an enteral feeding syringe or set through to an ENFit feeding tube connector for enteral applications. The device is single use for patients who require enteral feeding.

The ENFit to ENFit Extension Sets are sterile, single use devices. The extension sets are single and bifurcated port tubing sets with ENFit input port(s) and tethered caps, extension set tubing and clamp(s), and a single ENFit connector on the patient end. The ENFit connectors allow the extension set to be connected to other enteral devices that also have ISO 80369-3 compliant connectors. The extension sets are available in the listed lengths from 50 to 150 cm.

The feeding tube is indicated for use in percutaneous placement of an enteral feeding tube in adult and pediatric patients that require enteral feeding, medication, or decompression through an established gastrointestinal stoma tract. The Kangaroo Skin Level Gastrostomy Device Feed Set Kit with ENFit® Connection is indicated for use in adult and pediatic patients that require enteral feeding, medication administration, or decompression through a Kangaroo Skin Level Device.

The Kangaroo ™ Skin Level Balloon Gastrostomy Kit will be comprised of one Kangaroo™ Skin Level Device and one of each of the feed sets. The feed sets, continuous and bolus, are also available in Feed Set Kits packaged individually and then boxed as a 10-pack. The Kangaroo™ SLD is constructed primarily of silicone and consists of a hub which is overmolded on to a previously extruded bi-lumen shaft. The tip of the shaft is filled with radiopaque barium RTV. At the distal end, a silicone subsumed tip balloon is reverse bonded to the shaft using a silicone RTV. This subsumed tip balloon accomplishes patient comfort by not exposing the tip of the shaft to the patient as well as being in line with the shaft. In use, the balloon end of the catheter is inserted through a gastrointestinal stoma tract and into the stomach. The balloon is then inflated with sterile or distilled water (per the recommended volume for the specific device size) to secure the device in place. To confirm placement of the device in the stomach, fluoroscopic procedures are typically used since the catheter shaft tip has radiopaque barium stripe present. Accessories for the Kangaroo™ SLD include two feed extension set confiqurations (ENFit bolus and continuous), an inflation syringe, a feeding syringe (ENFit), and gauzes. The hub has two ports. The top (center) port contains a reflux valve assembly which is keyed to accept the feed set valve connectors. Leaks are prevented by the reflux valve assembly (with cross-slit valve design). The second port is the inflation port and contains the inflation valve. The device is available in the configurations per determined market needs shown below in Table 5.5-2. The feed extension sets have a valve connector end that inserts into the Kangaroo™ SLD reflux valve. For these ENFit Feed Sets, the opposite end has an ENFit-compatible connector complying with ISO 80369-3 (for prevention of misconnections with nonenteral feeding devices). The extension set can then connect to any ENFit-compatible enteral giving sets or ENFit-compatible syringes. Finally, both the Kangaroo™ Skin Level Device and the Kangaroo™ Feed Sets are compatible with competitor devices currently on the market.

This product is intended for use in neonatal and pediatric patients to provide nutrition via nasal or orogastric placement. The Polyurethane Feeding Tube is not intended for use beyond 30 days. The PVC Feeding Tube is not intended for use beyond 24 hours.

The Feeding Tube consists of the following main components: a feeding tube single lumen catheter and an enteral only connector hub with integral tethered connection closure plug. The catheter tubing is made of Polyurethane or PVC. The catheter tubing has an orange or purple radiopaque stripe of barium sulfate embedded in the tubing wall which can be visualized on x-ray, for exact placement of the tip. The single lumen catheter tubing has side holes for better flow and to provide multiple openings for aspiration. The proposed Feeding Tube is sterilized by Ethylene Oxide Gas to achieve a SAL of 10-6 and supplied sterility maintenance package which could maintain the sterility of the device during the shelf life of three years.

The Vonco Products EnteraLoc Flow spouted pouch with ENFit® Connector is indicated for use as a dispenser of enteral nutrition by way of direct connection to a feeding tube or extension set. It is intended to deliver nutrition into the gastrointestinal system of a patient. The pouch, once filled, is intended to be used in clinical or home care settings by users ranging from laypersons to clinicians, in all age groups.

The Vonco Products EnteraLoc Flow spouted pouch with ENFit® Connector consists of a foil pouch with an integrated female ENFit® connector at one end. The EnteraLoc Flow pouch is provided with a tamper evident cap. The pouch is designed to be pre-filled with liquid nutrition formula for tube feeding. EnteraLoc Flow is a single use device. EnteraLoc Flow spouted pouch with ENFit® Connector is designed as a single use, over-the-counter device. The pouches will be available in a range of sizes, with a range of nutritional values (based upon the formula which the pouch is filled). Based upon the required nutritional intake requirements, the user will select the proper size pouch and quantity for feeding.

Mobility+ is intended to deliver liquid nutrition formula, to an enteral access device (feeding tube) in users aged 2 years and over.

The Mobility+ Enteral Feeding System ("Mobility+" or the "System") is a portable, lightweight, nonelectronic, disposable enteral feeding system intended to deliver liquid nutrition formula to an enteral access device (feeding tube) in users aged 2 years and over in the clinical or home care settings. The device is for single patient use, disposable and intended for use over a 24 hour period. The System has three primary components; food pouch, filling set and giving set.

The Nasogastric Feeding Tubes – ENFit Port - PVC are intended for hydration, feeding and administration of oral medications for patients who require enteral feeding. This product is single use for no longer than 24 hours.

The Nasogastric Feeding Tubes – ENFit Port - PVC are sterile, single use devices. The feeding tubes consist of a graduated polyvinyl chloride tube, with radiopaque edge. The tubes have a closed tip and two lateral eyes for Fr sizes 5 to 10 and three lateral eyes for Fr sizes 12 to 16. The tubes have at the other end an ENFit male connector in ABS with its Polypropylene cap. A tether in thermoplastic polyurethane connects the ENFit connector to its cap. The ENFit connector allows the device to be connected to female enteral devices that have an ISO 80369-3 compliant connector. The feeding tubes are available in 50cm and 90cm lengths and in French sizes from 5 to 16.