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stay•safe® catheter extension set with Safe-Lock, 12 inch: The stay•safe catheter extension set with Safe-Lock is indicated for use in patients with acute and chronic end-stage renal disease undergoing peritoneal dialysis (PD) in a healthcare facility or at home. The stay•safe catheter extension set with Safe-Lock is used to connect a PD catheter with Safe-Lock compatible catheter adapter to PD systems that use stay•safe PIN technology. stay•safe® catheter extension set with Luer-Lock, 6 inch; stay•safe® catheter extension set with Luer-Lock, 12 inch; and stay•safe® catheter extension set with Luer-Lock, 18 inch: The stay•safe catheter extension set with Luer-Lock is indicated for use in patients with acute and chronic end-stage renal disease undergoing peritoneal dialysis (PD) in a healthcare facility or at home. The stay•safe catheter extension set with Luer-Lock is used to connect a PD catheter with Luer-Lock catheter adapter to PD systems that use stay•safe PIN technology. stay•safe® to Luer-Lock Adapter, 4 inch: The stay•safe to Luer-Lock adapter is indicated for use in patients with acute and chronic end-stage renal disease undergoing peritoneal dialysis (PD) in a healthcare facility or at home. The stay•safe to Luer-Lock adapter is used to connect a stay•safe catheter extension set to medical devices with a Luer-Lock connection.

The stay•safe® catheter extension set with Safe-Lock, 12 inch (Safe-Lock extension set) stay•safe® catheter extension set with Luer-Lock, 6 inch, stay•safe® catheter extension set with Luer-Lock, 12 inch, and stay•safe® catheter extension set with Luer-Lock, 18 inch (Luer-Lock extension sets), and stay•safe® to Luer-Lock adapter, 4 inch (Luer-Lock adapter), hereinafter collectively referred to as the "Catheter Extension Sets" are the subject devices of this 510(k). The Safe-Lock extension set is a single-use device designed to connect a PD catheter to PD systems that use the stay•safe PIN technology. The Safe-Lock extension set is provided sterile and non-pyrogenic. The Safe-Lock extension set is sterilized using ethylene oxide (EO). The Luer-Lock extension sets are single-use devices designed to connect a PD catheter to PD systems that use the stay•safe PIN technology. The Luer-Lock extension sets are provided sterile and non-pyrogenic. The Luer-Lock extension sets are sterilized using EO. The Luer-Lock adapter is a single-use device designed to connect a stay•safe catheter extension set to a medical device with a Luer lock connector. The Luer-Lock adapter is provided sterile and non-pyrogenic. The Luer-Lock adapter is sterilized using EO.

These sets are used during Peritoneal Dialysis therapy to transfer peritoneal dialysis solution to the patient catheter from the source solution container.

The MiniCap Extended Life PD Transfer Set with Twist Clamp – Code 5C4482A and MiniCap Extended Life PD Transfer Set with Twist Clamp - Extra Short - Code 5C4483 are single use, sterile, non-pyrogenic devices for use with Baxter peritoneal dialysis systems. A Transfer Set is connected to a Titanium Adapter that is at the end of an implanted peritoneal catheter. The Transfer Sets stay connected to the patient and allow for the exchange of peritoneal dialysis solution into and out of the peritoneal cavity as prescribed.

This bag is intended for the collection of effluent during Automated Peritoneal Dialysis (APD) Therapy.

Baxter's Cycler Drainage Bag product line currently consists of a sterile 15L Cycler Drainage Bag (5C4145P). This 15 L Cycler Drainage Bag is a single use device intended for the collection of effluent during Automated Peritoneal Dialysis (APD) Therapy and can be used with Baxter's APD Sets with Cassette, Manifold Sets and Extension Sets. The purpose of this drain bag is to allow the collection of the spent effluent in the event that a patient does not have access to a drain from the location where APD therapy is performed. The basis for this submission is the addition of a non-sterile version of the 15L Cycler Drainage Bag to the current product line. The product line does not come into direct or indirect contact with the patient's body tissue. The intended use, material, design, and function of the proposed device will be the same as the currently marketed 15 L Cycler Drainage Bag.

This set is used during Peritoneal Dialysis therapy to transfer peritoneal dialysis solution to the patient from the source solution container.

The MiniCap Extended Life PD Transfer Sets are single use, sterile, non-pyrogenic devices for use with Baxter peritoneal dialysis systems. A Transfer Set is connected to a Titanium Adapter that is at the end of an implanted peritoneal catheter. The Transfer Sets stay connected to the patient and allows for the exchange of peritoneal dialysis solution into and out of the peritoneal cavity as prescribed.

The stay safe catheter extension set with Safe-Lock is indicated for use in patients with acute and chronic end-stage renal disease undergoing peritoneal dialysis (PD) in a healthcare facility or at home. The stay safe catheter extension set with Safe-Lock is used to connect a PD catheter with Safe-Lock compatible catheter adapter to PD systems that use stay safe PIN technology. The stay safe catheter extension set with Luer-Lock is indicated for use in patients with acute and chronic end-stage renal disease undergoing peritoneal dialysis (PD) in a healthcare facility or at home. The stay safe with Luer-Lock is used to connect a PD catheter with a Luer-Lock catheter adapter to PD systems that use stay safe PIN technology. The stay safe to Luer-Lock adapter is indicated for use in patients with acute and chronic end-stage renal disease undergoing peritoneal dialysis (PD) in a healthcare facility or at home. The stay safe to Luer-Lock adapter is used to connect a stay safe catheter extension set to medical devices with a Luer-Lock connection.

The stay safe® catheter extension set with Safe-Lock (hereinafter referred to as "Safe-Lock extension set") is a single-use device designed to connect a PD catheter to PD systems that use staysafe PIN technology. The Safe-Lock extension set is provided sterile and non-pyrogenic. The Safe-Lock extension set is sterilized using ethylene oxide (EO). The stay safe® catheter extension sets with Luer-Lock (hereinafter referred to as "Luer-Lock extension sets") are single-use devices designed to connect a PD catheter to PD systems that use stay safe PIN technology. The Luer-Lock extension sets are provided sterile and non-pyrogenic. The Luer-Lock extension sets are sterilized using EO. The stay safe® to Luer-Lock adapter (hereinafter referred to as "Luer-Lock adapter") is a single-use device designed to connect a stay safe catheter extension set to a medical device with a Luer lock connector. The Luer-Lock adapter is provided sterile and non-pyrogenic. The Luer-Lock adapter is sterilized using EO.

Multiple Tubing Segment (MTS) Set with stay safe® PIN Connectors: The Multiple Tubing Segment (MTS) Set with stay safe PIN Connectors is indicated for use by patients with acute and chronic end-stage renal disease undergoing peritoneal dialysis (PD) in a healthcare facility or at home. The MTS Set is placed during set-up to make additional connections to the cycler set when an interruption in treatment is necessary. This device is compatible with stay safe Peritoneal Dialysis (PD) connectology system and is to be used only with Fresenius Medical Care (FMCNA) Cyclers and Cycler Sets. stay·safe® Drain Set: The stay safe Drain Set is indicated for use by patients with acute and chronic end-stage renal disease undergoing peritoneal dialysis (PD) in a healthcare facility or at home. The staysafe Drain Set is used to connect directly to the stay safe catheter extension set to enable drainage and/or effluent sampling as needed. This device is compatible with Fresenius Medical Care (FMCNA) Peritoneal Dialysis (PD) stay safe catheter extension sets.

Multiple Tubing Segment (MTS) Set with stay safe® PIN Connectors: The MTS Set is a single-use device that provides additional connections/disconnections when used with a stay safe compatible cycler set during acute and chronic peritoneal dialysis (PD) treatment. The MTS Set is provided sterile and non-pyrogenic. The MTS Set is sterilized using ethylene oxide (EO). The MTS Set consists of two (2) stay safe PIN Connectors at the proximal end, tubing, and a Safe-Lock connector at the distal end. stay·safe® Drain Set: The Drain Set is a single-use device that connects directly to the patient's stay safe catheter extension set to enable effluent drainage as needed. The Drain Set is provided sterile and non-pyrogenic. The Drain Set is sterilized using ethylene oxide (EO). The Drain Set consists of an empty three (3) L drain bag, a stay safe PIN connector, a sample port, tubing, and a low force clamp.

The Cycler Drain Bag Set is indicated for use by patients with acute and stage renal disease undergoing peritoneal dialysis (PD) in a healthcare facility or at home. The Cycler Drain Bag Set is an optional receptacle that connects to the Luer-lock end of a Cycler Set drain line in order to collect patient effluent during PD treatments. This device is to be used only with Fresenius Medical Care (FMCNA) Cyclers and Cycler Sets.

The Drain Bag Set (tubings and flexible bags) is a passive, closed drainage system used as an optional receptacle during an APD treatment. The Drain Bag Set is used to collect effluent in bags rather than letting the effluent flow directly to a drain. The Drain Bag Set connects to the drain line of a cycler set to collect patient effluent by means of gravity and the pumping action of a Peritoneal Dialysis (PD) cycler. The Drain Bag Set connects to the drain line using a standard Luer lock connection. The Drain Bag Set consists of three (3) interconnected 7-liter drain bags, each with a sampling port and an occluding clamp. The tubing lines that connect each drain bag to the drain line have a snap-disconnect tubing segment. This tubing segment allows the user to disconnect individual bags by snapping the tubing apart.

The PuraCath™ Firefly IM Peritoneal Dialysis Connector Disinfecting System is intended for use by PD (peritoneal dialysis) patients as a method of controlling air and touch contamination while performing a solution exchange dialysis patiens as a nethod of connector Disinfecting System is comprised of Firefly™ UV Purification Device, FireflyTM Transfer Catheter, FireflyTM Luer Cover, and FireflyTM 99% IPA bottle. The effectiveness of the PuraCath Firefly Peritoneal Dialysis Connector Disinfecting System was tested in viro against The enectivelless of the Funceoccus epidermidis, Escherichia coli, Pseudomonas aeruginosa, Streptococus Staphylococcus autous, Staphylococcus aureus, and Candida albicans yielding ≥ 4log reduction in microorganisms. The PuraCath Firefly Peritoneal Dialysis Connector Disinfecting System may be used in the home or a healthicare facility.

The PuraCath Firefly Peritoneal Dialysis Connector Disinfecting System provides a way for patients to ensure the cleanliness of the fluid connections associated with ambulatory peritoneal dialysis. The system accomplishes cleaning with a combination of alcohol, flushing with sterile dialysate, and ultraviolet (UV) light. The System consists of the components shown below. The Firefly UV Purification Device is a multi-year reusable device which helps to clean the connection between the Firefly Transfer Catheter and the dialysate Y-set (Y-set). The UV Purification Device is powered by off-the-shelf, replaceable AA batteries. The UV Purification Device directs ultraviolet (UV) light through the Transfer Catheter connector. UV Purification Device uses lights and an audible alert to indicate device status. The Firefly Transfer Catheter is a sterile, 6 month use, disposable device providing communication between the indwelling patient catheter and the Y-set. A proprietary, UV transparent control valve on the end of the Transfer Catheter allows for draining and filling the peritoneum. The control valve is actuated manually, adjustable between fully open and fully closed. The Transfer Catheter also has a flush feature. The flush feature allows for flushing of air and potential contaminants from the Y-set prior to fluid exchange. The Firefly Luer Cover is a 6 month use, disposable, UV transparent component designed to protect the Transfer Catheter connector between uses and to aid in keeping the control valve closed. The Firefly IPA Dropper Bottle provides a convenient way to apply 99% IPA solution to the inside of the Y-set and Transfer Catheter connectors.

FlexiCap Disconnect Cap with Povidone-Iodine Solution (5C4456): This device is intended for use in the treatment of patients with renal failure to isolate the Luer patient line connector of the Baxter APD (Automated Peritoneal Dialysis) disposable set during temporary disconnections and during the dwell phase of therapy. MiniCap with Povidone-Iodine Solution (5C4466P): This device is a plastic disconnect cap for peritoneal dialysis and contains povidone-iodine intended to protect the female Luer connector of the Baxter transfer set.

FlexiCap Disconnect Cap with Povidone-Iodine Solution (FlexiCap) is a single use device that connects to the patient line connector of the Baxter Automated Peritoneal Dialysis (APD) set and is designed to isolate the line during temporary disconnections and the dwell phase of peritoneal dialysis therapy sessions. The FlexiCap consists of a molded low density polyethylene cap which contains a polyurethane foam sponge and 10% povidone-iodine (PVP-I) solution. MiniCap with Povidone-Iodine Solution (MiniCap) is a single use device that connects to a Baxter transfer set and is designed to isolate the line between peritoneal dialysis therapy sessions. The MiniCap consists of a molded low density polyethylene cap which contains a polyurethane foam sponge and 10% Povidone-Iodine (PVP-I) solution.

MiniCap Extended Life PD Transfer Sets: This set is used during Peritoneal Dialysis therapy to transfer peritoneal dialysis solution to the patient from the source solution container. Locking Titanium Adapter for Peritoneal Dialysis Catheter: The Locking Titanium Adapter for Peritoneal Dialysis Catheter is intended to secure the peritoneal catheter tubing to the Baxter transfer set used during Peritoneal Dialysis therapy. Locking Cap for Peritoneal Dialysis Catheter Adapter: This device is indicated for use in the treatment of patients receiving peritoneal dialysis therapy, to cap the Locking Titanium Adapter for Peritoneal Dialysis Catheter between Baxter Transfer Set installations.

The MiniCap Extended Life PD Transfer Sets are single use, sterile, non-pyrogenic devices for use with Baxter peritoneal dialysis systems. A Transfer Set is connected to a Titanium Adapter that is at the end of an implanted peritoneal catheter. The Transfer Sets stay connected to the patient and allows for the exchange of peritoneal dialysis solution into and out of the peritoneal cavity as prescribed. The Locking Titanium Adapter for Peritoneal Dialysis Catheter (Titanium Adapter) and Locking Cap for Peritoneal Dialysis Catheter (Locking Cap) are single use, sterile, non-pyrogenic devices for use with Baxter peritoneal dialysis systems. The Titanium Adapter is a device that is secured to the end of a peritoneal dialysis catheter and is used to connect the peritoneal dialysis catheter to the Transfer Sets. The Locking Cap is used to cap the end of the Titanium Adapter between Transfer Set installations.