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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.

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 Entuit LP Patient Care Kit is indicated for use in adult and pediatric patients that require enteral feeding, medication administration or decompression through an Entuit LP Gastrostomy BR Balloon Retention Feeding Tube. The Entuit LP Patient Care Kit with ENFit Connection is indicated for use in adult and pediatric patients that require enteral feeding, medication administration or decompression through an Entuit LP Gastrostomy BR Low Profile Balloon Retention Feeding Tube. 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 PromaX LP Patient Care Kit with ENFit is indicated for use in adult and pediatric patients that require enteral feeding, medication administration, or decompression through a PromaX Low Profile Gastrostomy Feeding Tube.

The proposed low profile devices are constructed primarily of silicone and consists of a hub which is overmolded on to a previously extruded bi-lumen shaft. At the distal end, a silicone balloon is bonded to the shaft using a silicone RTV. The tip of the shaft is filled with radiopaque barium RTV. The hub has two ports. The top (center) port contains a reflux valve assembly which is keyed to accept the extension set 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. 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 proposed devices include two extension set configurations (bolus and continuous, each available in both ENFit-compatible version and non-ENFit compatible version due to ENFit market transition status), an inflation syringe, a feeding syringe (similarly available in both ENFit compatible and non-ENFit compatible versions), gauzes, and a stoma measuring device (for the Entuit offering) to facilitate device placement and use.

The Bi-Funnel and Tri-Funnel Gastrostomy Feeding Tubes with ENFit® connector are indicated for placement in adult populations that require enteral feeding, medication administration or gastric decompression through an established gastrointestinal stoma tract. The Entuit® Gastrostomy BR Balloon Retention Feeding Tube with ENFit® Connection is intended to provide gastric access for enteral feeding, medication administration and decompression through an established gastrointestinal stoma tract. The Entuit® Gastrostomy BR Balloon Retention Feeding Tube with ENFit® Connection is indicated for use in percutaneous placement of an enteral feeding tube in adult and pediatric patients that require enteral feeding, medication administration or decompression through an established gastrointestinal stoma tract.

The Gastrostomy Feeding Tube (G-tube) consists of two product versions (models): a Bi-Funnel G-Tube and a Tri-Funnel G-Tube. Each G-Tube version is offered in varying shaft French (FR) sizes and balloon sizes. Both versions are offered in the same functional length. The overall difference between the Bi-Funnel and Tri-Funnel G-tubes is that the Tri-Funnel G-Tube allows for simultaneous delivery of feeding solutions and medications while the Bi-Funnel G-Tube allows for delivery of either feeding solutions or medications at a time. Both Bi-Funnel and Tri-Funnel G-Tubes consist of a silicone funnel, shaft, adjustable external bolster and balloon. The funnel for the Bi-Funnel G-Tube has two ports: one port houses the balloon inflation valve which allows for balloon inflation and deflation, and the other port houses the male ENFit connector which allows for delivery of feeding solutions and medication. The funnel for the Tri-Funnel G-Tube has three ports: one port houses the balloon inflation valve, the center port houses the male ENFit connector which allows for delivery of feeding solutions, and the last (side) port houses another male ENFit connector which allows for delivery of medications. Attached to the ENFit connectors are a tether and a cap. The cap is intended to cover the ENFit connector when the device is not in use and the tether is intended to secure the cap to the connector when the device is in use. The same ENFit connector, tether and cap components are used for both Bi-Funnel and Tri-Funnel G-Tubes. The remaining components (shaft, adjustable bolster and balloon) are commonly shared for the Bi-Funnel and Tri-Funnel G-Tubes and are identical in both versions. The Entuit® Gastrostomy BR Balloon Retention Feeding Tube with ENFit® Connection is constructed primarily of silicone. The device consists of a tri-port funnel which is overmolded onto a previously extruded bi-lumen shaft. A retention bolster is molded separately and placed over the shaft. At the proximal end, a silicone balloon is bonded to the shaft using silicone RTV. The tip of the shaft is filled with radiopaque barium RTV. In use, the balloon end of the catheter is inserted through a gastrointestinal stoma tract and into the stomach lumen. The balloon is then inflated to the rated volume using sterile or distilled water and the bolster adjusted down to the skin to secure the device in place. The funnel has three ports. One port contains the inflation valve and used for inflation of the balloon. The center port houses the male ENFit connector which allows for the delivery of feeding solutions. The third (side) port houses another male ENFit connector which allows for delivery of medications. Attached to the ENFit connectors are a tether and a cap. The cap is intended to cover the ENFit connector when the device is not in use and the tether is intended to secure the cap to the connector when the device is in use. The funnel configuration and ENFit connectors/caps are identical to the Tri-Funnel Gastrostomy Feeding Tube with ENFit connector discussed in 5.4.1 above.

The Entuit The Thrive Balloon Retention Gastrostomy Feeding Tube is indicated in adult and pediations for use in percutaneous placement of an Enteral feeding tube for feeding tube feeding and/or administration of medication in conjunction with an established GI stoma to act The replacement tube may also be used for gastric decompression.

The Entuit™ Thrive I.P Balloon Retention Gastrostomy Feeding Tube is constructed primarily of silicone. The low profile device consists of a hub which is overmolded onto a previously extruded bilumen shaft. At the proximal end, a silicone balloon is bonded to the shaft using a silicone RTV. The tip of the shaft is filled with radiopaque barium RTV. In use, the balloon end of the catheter is inserted through a gastrointestinal stoma tract and into the stomach lumen. The balloon is then inflated with 5mL sterile or distilled water to secure the device in place. Accessories for the Low Profile device include two extension set configurations, an inflation syringe, a catheter tip syringe, gauzes and a stoma measuring device to facilitate device placement and use.

The Entuit™ Thrive Balloon Retention Gastrostomy Feeding Tube is intended to provide gastric access for enteral feeding, medication and decompression through an established gastrointestinal stoma tract. The Entuit™ Thrive Balloon Retention Gastrostomy Feeding Tube is indicated for use in percutaneous placement of an enteral feeding tube in adult and pediatric patients that require enteral feeding, medication administration or decompression through an established gastrointestinal stoma tract.

The Entuit The Thrive Balloon Retention Gastrostony Feeding Tube is constructed primarily of silicone. The device consists of a tri-port funnel which is overmolded onto a previously extruded bi-lumen shaft. A retention bolster is molded separately and placed over the shall. At the proximal end, a silicone balloon is bonded to the shaft using silicone RTV. The tip of the shaft is filled with radiopaque barium RTV. In use, the balloon end of the catheter is inserted through a gastrointestinal stoma tract and into the stomach lumen. The balloon is then inflated to the rated volume using sterile or distilled water and the bolster adjusted down to the skin to secure the device in place.