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The PICC Maximal Barrier Nursing Kit with BioFlo Hybrid PICC with Endexo Technology and PASV Valve Technology is indicated for short- or long-term peripheral access to the central venous therapy, including but not limited to, the administration of fluids, medications and nutrients, the sampling of blood, and for power injection of contrast media. Non-valved lumens are indicated for central venous pressure monitoring. The maximum power injection flow rate for the NMI HPICC III is 6 mL/sec. The PICC Maximal Barrier Nursing Kit with BioFlo PICC with Endexo Technology is indicated for short- or long-term peripheral access to the central venous system for intravenous therapy, including but not limited to, the administration of fluids, medications and nutrients, the sampling of blood, for central venous pressure monitoring and for power injection of contrast media. The PICC Maximal Barrier Nursing Kit with BioFlo PICC with Endexo Technology and PASV Valve Technology is indicated for short or long-term peripheral access to the central venous therapy, including but not limited to, the administration of fluids, medications and nutrients, the sampling of blood, and for power injection of contrast media. The Maximal Barrier Nursing Kit with BioFlo Midline Catheter is indicated for short term access (< 30 days) to the peripheral venous system for intravenous therapy, including but not limited to, the administration of fluids, medications and the sampling of blood and blood products. The PICC Maximal Barrier Nursing Kit with Xcela Hybrid PICC with PASV Valve Technology is indicated for short or long-term peripheral access to the central venous system for intravenous therapy, including but not limited to, the administration of fluids, medications and nutrients, the sampling of blood, and for power injection of contrast media. Non-valved lumens are indicated for central venous pressure monitoring. The maximum power injection flow rate for the Xcela Hybrid PICC with PASV Valve Technology is 6 mL/sec The Xcela PICC with PASV Valve Technology is indicated for short or long-term peripheral access to the central venous system for intravenous therapy, including but not limited to, the administration of fluids, medications and nutrients, the sampling of blood, and for power injection of contrast media. The PICC Maximal Barrier Nursing Kit with Xcela Power Injectable PICC is indicated for short or long-term peripheral access to the central venous system for intravenous therapy, including but not limited to, the administration of fluids, medications and nutrients, the sampling of blood, and for power injection of contrast media.

The PICC Maximal Barrier Nursing Kit is a packaging configuration containing a specified NMI PICC along with (1) procedural aides typically used for PICC placement and (2) maximal barrier precaution devices based upon recommendations of Center of Disease Control and Prevention (CDC).

The BioFlo Midline catheter is indicated for short term access to the peripheral venous therapy, including but not limited to, the administration of fluids, medications and the sampling of blood and blood products.

The BioFlo Midline Catheter is a short term peripheral venous access device between 3 to 10 inches in length (8 to 25 cm). Midlines are usually placed in an arm vein such as the basilic, brachial or cephalic and the tip ends below the level of the axillary line. Midline catheters are longer than peripheral IV catheters which are generally 1 to 3 inches long and shorter than peripherally inserted central catheters (PICC) which extend into the superior vena cava. This device provides an alternative to short peripheral IVs and PICCs for certain treatments.

The NMI Port and NMI Port II with and without PASV Valve Technology are indicated for patients who require longterm access to the central venous system for administration of fluids including but not limited to hydration fluids, chemotherapy, analgesics, nutritional therapy and blood products. The device is also indicated for blood specimen withdrawal. When used with a power injectable needle, the NMI Port II are indicated for power injection of contrast media. The maximum recommended infusion rate is 5 ml/sec with a 19G or 20G non-coring power injectable needle or 2 ml/sec with a 22G non-coring power injectable needle.

The NMI Port and NMI Port II with and without PASV Valve Technology are a subcutaneous implantable venous access device with one reservoir and is designed for optional power injection of contrast media, CECT. The ports are designed to be accessed using a non-coring Huber needle introduced through the skin into the self-sealing silicone septum covering the reservoir. The NMI Port and NMI Port II are available in plastic or titanium single lumen and valved or nonvalved configurations. The ports are available with either silicone filled or non-filled suture fixation holes. Ports with non-filled suture fixation holes are generally utilized based on clinical need to anchor the port to the subcutaneous tissue; whereas ports with filled suture holes, designed to prevent tissue in-growth to the suture holes, are generally utilized when not anchoring the port to the subcutaneous tissue. If needed, filled suture holes are accessed through the silicone. All port configurations have a radiopaque identifier (CT mark) to identify the port as power injectable. The radiopaque catheter has graduated marks at 1 centimeter intervals and can be cut to the desired length by the clinician. Ports are provided with a variety of procedural accessories. The NMI Port II catheter shaft incorporates Endexo polymer for improved resistance to thrombus accumulation and/or formation on the catheter.

Exodus Array Multipurpose Drainage Catheters are intended for percutaneous drainage of fluid or air in the chest, abdomen and pelvis, e.g., abscesses, cysts, pneumothoraces, and other general purpose drainage applications. Exodus Nuance Nephrostomy Drainage Catheters are intended for percutaneous drainage of fluid collections in the urinary system. Exodus Believe Biliary Drainage Catheters are intended for percutaneous drainage of the biliary tree.

The Exodus Drainage Catheter consists of a radiopaque polyurethane catheter. The distal end of the catheter is configured as a locking pigtail and is coated with GLYCE hydrophilic coating. Catheter markings are provided in centimeters on the shaft to indicate the distal tip. The Exodus Array Multipurpose Drainage Catheter (when applicable) and the Exodus Believe Biliary Catheter include a polymer marker to assist with catheter placement. The proposed Exodus Drainage Catheters will include the following accessories: a metal cannula and a plastic cannula (all product offerings) and a 0.038" trocar needle (in multipurpose offerings only).

The Xcela Power Injectable PICC is indicated for short or long-term peripheral access to the central venous system for intravenous therapy, including but not limited to, the administrations and nutrients, the sampling of blood, and for power injection of contrast media. The Xcela PICC with PASV Valve technology is indicated for short or long-term peripheral access to the central venous system for intravenous therapy, including but not limited to, the administrations and nutrients, the sampling of blood, and for power injection of contrast media. The Xcela Hybrid PICC with PASY Valve technology is indicated for short or long-term access to the central venous system for intravenous therapy, including but not limited to, the administration of fluids, medications and nutrients, the sampling of blood, and for power injection of contrast media. Non-valved lumens are indicated for central venous pressure monitoring. The maximum power injection flow rate is 6 mL/sec.

The proposed device has identical technological characteristics and performance as the predicate intravascular catheters. Both the proposed and predicate devices are, in brief, intended for short- or long-term peripheral access to the central venous system for intravenous therapy, blood sampling, and power injection of contrast media. available in single and multi-lumen configurations in a wide range of sizes from 3F to 6 F outside catheter diameter; rated for maximum power injector settings up to 325 psi rated for maximum power injection flow rate up to 6 ml/second based on model; and available kitted with a range of procedural accessories for user convenience. The only difference compared to the current Xcela Power Injectable PICC, Xcela PICC with PASV Valve and Xcela Hybrid PICC with PASV Valve catheters cleared via K093366, K111906 and K150527 is a change of the catheter shaft, luer and suture wing print ink.

The BioFlo Midline Catheter is indicated for short term access (< 30 days) to the peripheral venous system for intravenous therapy, including but not limited to, the administration of fluids, medications and the sampling of blood and blood products. Therapies not appropriate for midline catheters include continuous vesicant therapy, parenteral nutrition, infusates with pH less than 5 or greater than 9, and infusates with an osmolarity greater than 600 mOsm/L. Maximum Power Injection Flow Rates: - 3F Single Lumen, 20cm: 2 mL/sec . - . 4F Single Lumen, 20cm: 6 mL/sec - . 5F Single Lumen, 20cm: 6 mL/sec - 5F Dual Lumen, 20cm: 6 mL/sec .

The BioFlo Midline Catheter is a short term (< 30 days) non-valved peripheral venous access devices between 3 to 10 inches in length (8 to 25 cm). Midlines are usually placed in an arm vein such as the basilic, brachial or cephalic and the tip ends below the level of the axillary line. Midline catheters are longer than peripheral IV catheters which are generally 1 to 3 inches long and shorter than peripherally inserted central catheters (PICC) which extend into the superior vena cava. This device provides an alternative to short peripheral IVs and PICCs for certain treatments.

The Xcela Power Injectable PICC is indicated for short- or long-term peripheral access to the central venous system for intravenous therapy, including but not limited to, the administrations and nutrients, the sampling of blood, and for power injection of contrast media. Maximum power injection flow rate: 4F Single Lumen, 45 cm - 4 mL/sec 4F Single Lumen, 55 cm - 3.5 mL/sec 5F Single Lumen, 55 cm - 5 mL/sec 5F Dual Lumen, 45 cm - 5 mL/sec 5F Dual Lumen, 55 cm - 4 mL/sec 6F Dual Lumen, 55 cm - 5 mL/sec

The Xcela Power Injectable PICC is a peripherally inserted central catheter. It is available in single and multi-lumen configurations in a wide range of sized from 4F to 6F outside catheter diameter. It is rated for maximum power injector settings up to 325 psi and rated for maximum power injection flow rate up to 5 ml/second based on model. It is available kitted with a range of procedural accessories for user convenience. Changes from the predicate device include the addition of an oversleeve to the extension tube, a new non-valved luer design, and inclusion of maximum flow rates into the indication statement.

The NMI PICC II and NMI PICCIV are indicated for short- or long-term peripheral access to the central venous system for intravenous therapy, including but not limited to, the administrations and nutrients, the sampling of blood, for central venous pressure monitoring and for power injection of contrast media. The NMI PICC III with PASV Valve Technology is indicated for short- or long-term peripheral access to the central venous system for intravenous therapy, including but not limited to, the administration of fluids, medications and nutrients, the sampling of blood, and for power injection of contrast media.

The proposed device has similar design, components and technological characteristics as the predicate intravascular catheters; the only difference between the predicate and proposed devices is the type of ink used on the markings of the catheter shaft.

The NMI PICC III is indicated for short-term or long-term peripheral access to the central venous system for intravenous therapy, including but not limited to, the administration of fluids, medications and nutrients, the sampling of blood, and for power injection of contrast media. Non-valved lumens are indicated for central venous pressure monitoring. The maximum power injection flow rate for the NMI PICC III is 6 mL/sec. The NMI PICC III with PASV Valve Technology is indicated for short- or long-term peripheral access to the central venous system for intravenous therapy, including but not limited to, the administration of fluids, medications and nutrients, the sampling of blood, and for power injection of contrast media. The Xcela Hybrid PICC with PASV Technology is indicated for short- or long-term peripheral access to the central venous system for intravenous therapy, including but not limited to, the administration of fluids, medications and nutrients, the sampling of blood, and for power injection of contrast media. Non-valved lumens are indicated for central venous pressure monitoring. The maximum power injection flow rate for the Xcela Hybrid PICC with PASV Valve Technology is 6 mL/sec. for short or long-term peripheral access to the central venous system for intravenous therapy, including but not limited to, the administration of fluids, medications and nutrients, the sampling of blood, and for power injection of contrast media.

The PICC Maximal Barrier Nursing Kit is a packaging configuration containing a specified NMI PICC, along with (1) procedural aides typically used for PICC placement and (2) maximal barrier precaution devices based upon recommendations of Center of Disease Control and Prevention (CDC). The associated accessories include: Sterile Kit: Ampule Breaker, Cannula 1 ¾" Filtered Straw, Cap, male, non-vented, Cover, Transducer, 4" x 58", CSR Wrap, Dilator/Sheath, 3-6F x 5 or 7 cm peelable, (sized to PICC), Drape, Full Body, Drape, Under arm, Drape, Fenestrated, Dressing, Tegaderm, Chloraprep 3mL clear and orange tint, Gauze 4" x 4", 4 ply, Gown, Surgical Extra Large, Guidewire, 0.18" x 45 cm, Hairnet, 24" large, Lidocaine ampule, Mask with earloops, Needle, echogenic 21G x 1.575" or 2.75" (sized to PICC), Needle, 25G x 5/8", Needle, safety 21 G x 2.75", PICC (based on family and size), Scalpel, #11, Safety, Scissors, Blunt, Sharps container, single, Skin Protectant Swab Stick, Statlock Plus Fixed Post (stabilization), Stiffening Stylet 0.014" or 0.016" x 70 cm (size to PICC), Syringe 5cc, Tape Measure, 36" Paper, Tape, Surgical 3/4" x 24", Tourniquet, 18" x 1", Towel, 14" x 25", Tuohy Borst Adapter w/side arm. Tandem Package (Pouch): Sterile OEM Devices in 'as received' packaging, Gloves, Surgeons, Pre-Filled Syringes, Saline.