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The TidalPort-AP™ Implantable Apheresis Vascular Access Port is indicated for therapies requiring repeated access to the vascular system. The port system can be used for long-term therapeutic apheresis, withdrawal of blood, and infusion of medications, I.V. fluids, parenteral nutrition solutions, blood, and blood products. The TidalPort-AP™ Implantable Apheresis Vascular Access Port is indicated for power injection of contrast media. For power injection of contrast media, the maximium recommended infusion rate is 5 mL/s.

The TidalPort-AP™ has one port size (Standard) and one catheter size (9.6F Polyurethane). It is designed to provide repeated access to the vascular system without the need for repeated venipuncture or the daily care of an external catheter. The TidalPort-APTM is available as a standard profile totally implantable, titanium port-based design and is accessed perpendicularly to the skin like a typical, conventional access port. For the purpose of apheresis, high-flow procedures, it is accessed with using the FDA Cleared 16G or 18G high-flow, non-coring needle Tidal High-Flow Non-coring Needle (K151341). The TidalPort-APTM can also be used for routine vascular access infusion or withdrawal using Huber point needle. For power injection infusion procedures, the subject device can be accessed with a power injection rated needle to create a power-injectable system. The design of the TidalPort-AP™ utilizes a spherical reservoir and an elongated radius contoured septum to achieve the design purpose of creating a port with a smaller reservoir and less clearance volume. The TidalPort-APTM comes with a number of kit components to aid in the implantation procedure and/or access of the device once implanted. The TidalPort-AP™ and necessary kit components are provided sterile (EtO). The overall implanted port system consists of three primary components: the titanium port body with a silicone septum, an attachable radiopaque polyurethane catheter, and a catheter lock which secures the catheter to the port body stem. Once implanted, the method of accessing the subject TidalPort-APTM device is the exact same as the predicate TidalPort™ device. After the implanted device has been identified and access is prepped per institutional policy, the user palpates the uniquely shaped port. Once the port is palpated, providing the location of the septum, the 16G or 18G high-flow needle (K151341) is inserted into the reservoir for apheresis procedure use. After the reservoir floor is reached, the stylet is unlocked and pulled back slightly, and the needle is once again advanced forward until contacting the reservoir floor again. The stylet is then completely removed, leaving the hollow cannula with luer lock fitting in place. After stylet removal, the cannula is attached to the appropriate extension set and secured for the necessary infusion or withdrawal procedure.

The Bard PowerFlow™ Implantable Apheresis IV Port is indicated for patient therapies requiring repeated access to the vascular system. The port system can be used for long-term therapeutic apheresis, withdrawal of blood, and infusion of medications, IV fluids, parenteral nutrition solutions, blood and blood products. The Bard PowerFlow™M Implantable Apheress IV Port is indicated for power injection of contrast media. For power injection of contrast media, the maximum recommended infusion rate is 5 mL/s.

The PowerFlow™ Implantable Apheresis IV Port with 9.6 Fr. ChronoFlex™ Catheter is designed to provide repeated access to the vascular system without the need for repeated venipuncture or the daily care of an external catheter. The PowerFlow™ Implantable Apheresis IV Port is a low profile totally implantable, angled access titanium port-based design and is accessed through an angled opening which consists of a funnel shaped entrance designed to guide the peripheral intravenous (P.I.V.) access needle and catheter into the subject device. The PowerFlow™ Implantable Apheresis IV Port comes with a number of kit components to aid in the implantation procedure and/or access of the device once implanted. The PowerFlow™ Implantable Apheresis IV Port and necessary kit components are provided sterile (EtO). The overall implanted system consists of three primary components: the port body with a silicone layered septum, an attachable radiopaque polyurethane catheter lock which secures the catheter to the port body stem. The method of implantation and access of the subject PowerFlow™ Implantable Apheresis IV Port is the exact same as the predicate PowerFlow™ Implantable Apheresis IV Port device. After the implanted device has been identified and access is prepped per institutional policy, the user palpates the uniquely shaped angled entry funnel. Once the funnel is palpated, providing the location of the introducer needle access path, the 14 or 16Ga introducer needle is inserted into the funnel. After the Introducer Needle Stop is reached, the Introducer Needle is pulled back slightly and the P.I.V. Catheter is advanced forward. The P.I.V. Catheter is then advanced through the silicone layered septum and the Introducer Needle is removed. After needle removal, the P.I.V. Catheter is attached to the appropriate extension set and secured for the necessary infusion or withdrawal procedure. The PowerFlow™ Implantable Apheresis IV Port can be used for routine vascular access infusion or withdrawal using a BD Insyte™ Autoguard™ Shielded IV Catheter. For power injection infusion procedures, the subject device can be accessed with a power injection rated IV catheter to create a power-injectable system.

The Bard PowerFlow™ Implantable Apheress IV Port is indicated for patient therapies requiring repeated access to the vascular system. The port system can be used for long-term therapeutic apheresis, withdrawal of blood, and infusion of medications, I.V. fluids, parenteral nutrition solutions, blood and blood products. The Bard PowerFlow™M Implantable Apheresis IV Port is indicated for power injection of contrast media. For power injection of contrast media, the maximum recommended infusion rate is 5 mL/s.

The PowerFlow Implantable Apheresis IV Port with 9.6 Fr. ChronoFlex Catheter is designed to provide repeated access to the vascular system without the need for repeated venipuncture or the daily care of an external catheter. The Bard PowerFlow Apheresis IV Port is a low profile totally implantable, angled access titanium port based design and is accessed through an angled opening which consists of a funnel shaped entrance designed to guide the peripheral intravenous (P.I.V.) access needle and catheter into the subject device. The PowerFlow Apheresis IV Port comes with a number of kit components to aid in the implantation procedure and/or access of the device once implanted. The PowerFlow Apheresis IV Port and necessary kit components are provided sterile (EtO). The overall implanted system consists of three primary components: the port body with a silicone layered septum, an attachable radiopaque polyurethane catheter lock which secures the catheter to the port body stem. The catheters used with infusion ports are essentially the same design as externalized, stand-alone intravascular catheters. Once implanted, the method of accessing the subject Bard PowerFlow Apheresis IV Port is the exact same as the predicate Bard CathLink 20 Titanium Port device. After the implanted device has been identified and access is prepped per institutional policy, the user palpates the uniquely shaped angled entry funnel. Once the funnel is palpated, providing the location of the introducer needle access path, the 14 or 16Ga introducer needle is inserted into the funnel. After the Introducer Needle Stop is reached, the Introducer Needle is pulled back slightly and the P.I.V. Catheter is advanced forward. The P.I.V. Catheter is then advanced through the silicone layered septum and the Introducer Needle is removed. After needle removal, the Peripheral IV Catheter is attached to the appropriate extension set and secured for the necessary infusion or withdrawal procedure. The PowerFlow Implantable Apheresis IV Port can be used for routine vascular access infusion or withdrawal using a BD Insyte Autoguard Shielded IV Catheter. For power injection infusion procedures, the subject device can be accessed with a power injection rated IV catheter to create a power-injectable system.