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For nasogastric oralgastric enteral feeding, incorporating safety connectors which eliminates the risk of IV administration through the feeding tube.

Nutrifit is a combined system of feeding tubes and extension sets. The feeding tubes are available in several configurations: Not made with DEHP PVC and Polyurethane (PUR). The PUR versions are available without stylet. All tubes include centimeter numerical markings from 5 to 35 cm for the 40, 50 and 75 cm feeding tubes and markings from 5 to 70 cm for the 90, 125 and 160 cm feeding tubes. The Nutrifit devices are single-use, disposable devices intention in adults and children. Nutrifit PVC feeding tubes are intended for enteral nutrition and for a short-term use, not longer than 5 days. Nutrifit PUR feeding tubes are intended for enteral nutrition and for a short-term use, not longer than 29 days. The Nutrifit accessories for this submission sets, which enable longer connections for the feeding tubes. They allow greater freedom of movement and greater flexibility and are available with or without a pinch clamp. Nutrift is ENFit compliant, meeting requirements for design and functional performance of small-bore connectors intended to be used for connections on enteral medical devices and accessories as detailed in ISO 80369-3.

The VR Medical Feeding Tube is intended for nasogastric delivery of various types of liquid nutritional media through the gastro intestinal tract of neonatal and small pediatric patients, and is not intended for use beyond 30 days. The Enteral Feeding Extension Set (EFES) is intended for use as an extension set for nasogastric / oralgastric or gastric tube enteral feeding tubes, incorporating safety connectors/small bore connectors which are intended to reduce the misconnection between the following applications: I.V. system and Enteral Feeding System. The EFES is indicated for use in neonatal and pediatric patients in connection with an enteral feeding tube to provide nutrition via nasal or oral gastric placements.

The VR Medical Feeding Tube is intended for nasogastric delivery of various types of liquid nutritional media through the qastro intestinal tract of neonatal, pediatric and is not intended for use beyond 30 days. They are sterile, individually packaged. The orange color coding provides easy visual recognition of the enteral connection. They are designed with a radiopague stripe for X-ray visualization to confirm proper feeding tube placement. They are marked with French size and markings to assist tube placement or check for migration. A tethered plug for connector closure is incorporated when not in use. The Enteral Feeding Extension Sets ("EFES") are intended to provide access from the feeding tube to a syringe or nutritional source accepting a connector for enteral applications. They are available in multiple configurations: with and without an in-line Y port and lengths. The EFES are sterile disposable device for single patient use only. The EFES is designed to connect existing feeding tubes (nasogastric, gastric, etc.) to various delivery enteral syringes as well as to help minimize the potential for inadvertent delivery of enteral feedings through the intravenous route. i.e., the device cannot be connected to a luer connector. The EFES consists of flexible tubing with an orange strip for easy quick identification of enteral feeding lines as well as a "For Enteral Feeding Only" tag and a slide clamp to provide the additional safety assurance for connection errors.

The InnerSense Esophageal Temperature Probe/Feeding Tube is a dual function, single-use sterile device which simultaneously provides continuous monitoring of esophageal temperature and delivers oral medications and/or enteral nutrition in neonatal and pediatric patients oro/nasogastrically, as directed by a physician for up to 30 days. The InnerSense device can be used solely for the purpose of monitoring esophageal temperature in situations where invasive monitoring is indicated.

The InnerSense Esophageal Temperature Probe/ Feeding Tube is a single- use, disposable, sterile device designed for nasogastric or orogastric placement in neonatal or pediatric patients. It is used to continuously monitor esophageal temperature, deliver oral medications and/or provide enteral feeding to a patient for up to 30 days. The InnerSense Esophageal Temperature Probe/ Feeding Tube can be used in neonates or children solely for temperature monitoring; it is not intended to be exclusively used for children who require enteral feeding. The device should be applied only under direct supervision of a licensed physician or healthcare provider and be safely connected only to an enteral giving set or syringe and the compatible patient monitor.

The InnerSense Esophageal Temperature/Feeding Tube is a dual function, single-use sterile device which simultaneously provides continuous monitoring of esophageal temperature and delivers oral medications and/or enteral nutrition in neonatal and pediatric patients oro/nasogastrically, as directed by a physician for up to 30 days. The InnerSense device can be used solely for the purpose of monitoring esophageal temperature in situations where invasive monitoring is indicated.

Philips' InnerSense Esophageal Temperature/Feeding Tube is a disposable, single-use, sterile device designed for nasogastric placement in neonatal and pediatric patients. It is used to continuously monitor esophageal temperature, deliver oral medications, and/or provide enteral feeding to a patient for up to 30 days. It should be used only under direct supervision of a licensed physician or healthcare provider, according to the hospital standard of care. Note: the temperature probe is auto-located in the distal esophagus when device is placed in accordance with the Insertion steps provided in the Application section of the IFU.

For nasogastric/oralgastric enteral feeding, incorporating safety connectors which reduce the risk of misconnections between feeding tubes and intravenous connectors.

The Nutrisafe 2 silicone feeding tubes are utilizing a different formulation of silicone material I he Nutrisate 2 silicone feeding tubes. The feeding tubes. The feeding tubes are available in several than the catisting Nutrioure is a unique connection does not incorporate a luer, reducing SIZCS, and the leveling system connains an IV administration set or other medical delivery the fisk of madvertenity connection reduces the risk of involuntary disconnection; voluntary systems: "The is achieved by simply unscrewing the hub connections.

For nasogastric/oralgastric enteral feeding, incorporating safety connectors which reduce the risk of misconnections between feeding tubes and intravenous connectors.

The Nutrisafe 2 feeding tubes are a product line extension to the existing Nutrisafe 2 feeding tubes. The subject feeding tubes are available in several sizes and in two materials. The feeding system contains a unique connection that does not incorporate a luer, reducing the risk of inadvertently connecting to intravenous connectors. The locking connection reduces the risk of involuntary disconnection; voluntary disconnection is achieved by simply unscrewing the hub connections.

The Oral Enteral Syringe is intended for the delivery of liquid medication, formula and breast milk.

The Oral Enteral Syringe is intended as a single use, sterile, device for the delivery of liquid medication, formula and breast milk. The Oral Enteral Syringe comes in multiple volume sizes ranging from 1cc to 60cc [e.g., 1cc, 3cc, 10cc, 20cc, 30cc and 60cc]. The VR Medical Oral Enteral Syringe, as well as the predicate device [Phillips Children's Medical Venture Oral/ Enteral Syringe (K100099)] has 'labeling' on the device itself, i.e., highly visible labeling on side of barrel marked ORAL/ENTERAL ONLY, and the utilization of bright orange colorant for the plunger and cap that easily distinguishes the syringe for feeding and not other uses. The Oral Enteral Syringe incorporates safety connectors which eliminate the risk of IV administration through the feeding tube, i.e., the safety connectors will not mate with Luer Lock or Leur slip fittings. The VR Medical Oral Enteral Syringe design incorporates various components, e.g., barrels, plungers, caps and end caps, which are comprised of commercially available materials with demonstrated acceptable biocompatibility, as listed below: Barrel Material: Polypropylene 370Y Piston Material: Thermoplastic Elastomer IR307 Plunger Material: Polypropylene 370Y Plunger Colorant: Orange Pigment* Cap Material: Polypropylene 370Y Cap Colorant: Orange Pigment (P21024) Barrel Gradation Ink: PPE Ink Series (on outside of barrel) Nozzle Material: Polypropylene 370Y (molded with barrel) The Oral Enteral Syringe does not contain natural rubber latex, DEHP, or BPA.

The MED-RX Pediatric Feeding Tube and Accessories are disposable, single use enteral feeding devices featuring non-luer enteral only connectors. The MED-RX Pediatric Feeding Tube is intended to be used for nasogastric enteral feeding, as directed by a physician. The MED-RX Enteral Extension Set is an accessory to the MED-RX Pediatric Feeding Tube, to be used to deliver fluids from the nutritional source to an existing non-luer pediatric feeding tube. The MED-RX Pediatric Feeding Tube and Accessories are for hospital use, pediatric patient use only, and are not intended for use beyond 30 days.

The MED-RX Pediatric Feeding Tube is intended to be used for nasogastric/oralgastric enteral feeding as directed by a physician. Accessories to be offered alongside the MED-RX Pediatric Feeding Tubes include MED-RX Enteral Extension Sets of various configurations. The MED-RX Enteral Extension Set is intended to be used to deliver fluids from the nutritional source to an existing non-luer pediatric feeding tube. The MED-RX Pediatric Feeding Tubes and Enteral Extension Sets feature non-luer enteral only connectors to decrease the risk of accidental misconnection. All devices are sterile, single-use, and latex free. The MED-RX Pediatric Feeding Tube and Accessories are for pediatric use only. Accessories may be sold with MED-RX Pediatric Feeding Tubes or separately.

The GUARDIAN CONNECTION™ is designed to be used with standard adult tapered feeding tube connectors to secure the connection.

The Guardian Connection is a non-sterile, reusable, plastic "Ushaped" clip designed to hold the connectors of an enteric feeding tube and an enteric feeding set together to help prevent inadvertent disconnection. The product is specifically designed to accommodate the non-IV tapered male conical stepped connectors and mating non-IV tapered female connectors commonly found on standard adult enteric feeding tubes and sets. The Guardian Connection clips around the outside of these connectors, and helps to prevent them from being pulled apart by tensile force.

Oral/Enteral Syringes are intended for the delivery of liguid medication, formula, and breast milk.

The Oral/Enteral Syringes are intended for the delivery of liquid medication, formula, and breast milk. The syringes incorporate safety connectors that mate with the Respironics Enteral Only Extension Set, but will not mate with Luer lock or Luer slip fittings. The safety connectors prevent inadvertent connection of the enteral system to an IV system or an IV system to the enteral system. The Oral/Enteral Syringe barrels, plungers and end caps are comprised of Polypropylene, and the pistons are comprised of Silicone.