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The PM2+ System and SmartPICC Stylet is indicated for guidance and positioning of commercially available central venous catheters. The Stylet provides stiffness for use in placement of the catheter, intravascular capability for ECG detection and recording for catheter guiding and positioning, and intravascular ionic dilution for supplemental catheter navigation. The SmartPICC Stylet, when used with the PM2+ System, provides real-time catheter tip location information by using the patient's physiological (cardiac electrical activity and blood flow) information. When relying on the patient's ECG signal, the PM2+ System and SmartPICC Stylet is indicated for use as an alternative method to fluoroscopy or chest x-ray for central venous catheter tip placement confirmation in adult patients. The SmartPICC Stylet is indicated for use with PICC lines having a minimum lumen diameter of 0.021". Limiting but not contraindicated situations for this technique are in patients where alterations of cardiac rhythm change the presentation of the P-wave as in atrial fibrillation, atrial flutter, severe tachycardia and pacemaker driven rhythm. In such patients, who are easily identifiable prior to central venous catheter insertion the use of an additional method is required to confirm catheter tip location.

The PM2+ System and SmartPICC Stylet is a device used by clinicians for bedside navigation and tip location confirmation of central venous catheters including PICCs. The PM2+ System and SmartPICC Stylet provide real-time catheter tip location information by using intravascular ECG (ivECG). The SmartPICC Stylet provides intravascular ECG for catheter tip location confirmation as well as an optional, ionic dilution navigation feature. The SmartPICC Stylet is used only during PICC installation, and removed once the PICC tip position is confirmed to be at the target location. The SmartPICC Stylet is electrically connected to the PM2+ system which processes, displays, and stores the ECG waveforms as well as the ionic dilution data. The PM2+ System is also compatible with the commercially available ECGuide Connector.

The Pilot TLS is indicated for use in positioning of PICCs. The Pilot TLS provides real-time catheter tip location information by displaying changes in the patient's cardiac electrical activity. Pilot TLS is indicated for use as an alternative method to chest X-ray or fluoroscopy confirmation of PICC tip placement in adult patients. Note: Limited, but not contraindicated, situations for this technique are patients where cardiac rhythms may change presentation of the P-wave: - Atrial fibrillation - Atrial flutter - Severe tachycardia - Pacemaker-Driven Rhythm - Chronic obstructive pulmonary disease (COPD) Such patients are easily identified prior to PICC insertion. Use of additional method is necessary to confirm catheter tip location.

Pilot TLS is designed to support quidance and tip positioning of Peripherally Inserted Central Catheters (PICCs) of at least 3 Fr in size. Pilot TLS provides real-time catheter tip location information by using the patient's cardiac electrical activity and is indicated for use as an alternative method to chest X-ray and fluoroscopy for PICC tip placement confirmation for adults. The device includes a medical tablet preloaded with Pilot software, a Pilot TLS module, an ECG cable accessory, and a Vygocard accessory. The device is only provided in one configuration, and non-sterile. The system is composed of: - . A medical tablet with a kickstand attached on the back - . The medical tablet's power supply - . A Pilot TLS module attached to a USB-A cable - A stabilization base (option to maintain the black ECG lead for its connection to Vygocard saline connector - An ECG cable with 4 leads (red, white, green, black) - 2 USB flash drives Vygocard is an accessory provided sterile.

Neonav is indicated for navigation and positioning of central venous access devices (CVADs) of at least 1Fr in size. Neonav provides real-time catheter tip location information by using the patient's cardiac electrical activity. Neonav is indicated for use as an alternative method to chest X-ray and fluoroscopy for all central venous access device tip placement confirmation. In adult patients and in adolescents (greater than 12 through 21 years of age), Neonav can be used with CVADs such as peripherally inserted central catheters (PICCs), centrally inserted central catheters (CICCs), implantable ports, and hemodialysis catheters; in children (greater than 2 to 12 years of age), Neonav can be used with CICCs; in infants (greater than 1 month to 2 years of age) and in neonates (from birth to 1 month of age), Neonav can be used with PICCs and CICCs. In each specific age group, the CVAD type and size must be chosen and the CVAD must be used according to the CVAD's indications and instructions for use. Limiting but not contraindicated situations for use of the Neonav are in patients where alterations of cardiac rhythm change the presentation of the P wave as in atrial flutter, severe tachycardia, and pacemaker driven rhythm. In such patients, who are easily identifiable prior to central venous access device insertion, the use of an additional method is required to confirm catheter tip location.

The Neonav ECG Tip Location System (Neonav) is a non-invasive medical device that analyzes electrocardiographic signals (ECG) to track the location of central venous access devices (CVADs) in patients' blood vessels during placement in real time via a display. Catheter position in the vasculature is analyzed based on the patient's intravascular ECG (I-ECG). An I-ECG is recorded via the catheter tip from within the blood vessels of a patient. For the conductive fluid method, the sterile Neonav ECG Adapter Cable are used whereas for guidewire/stylet method, the sterile Neonav ECG clip cable is used. These components allow the electrical impulses detected at the catheter tip to be recorded by a non-sterile Acquisition Unit and analyzed by the Neonav Console to assist in determining the catheter tip position. The Neonav Controlled via a touch screen interface or a Remote enclosed in a sterile cover. The Neonav Console displays real-time surface ECG and I-ECG signals, highlighted QRS complex, max measured P-wave, the patient's heart rate, and other device performance indicators. A surface electrode is placed on the subject to act as a reference electrode. A second surface electrode is placed on the subject for noise reduction. Neonav components are designed to attach easily to standard catheter and IV therapy components via standard luer lock connections. The only patient contacting component of the ECG Adapter. It has indirect contact with the patient via fluids and is composed of biocompatible polycarbonate and stainless steel.

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; central venous pressure monitoring; and power injection of contrast media. Rated for maximum power injection flow rate of 5.0ml/s

The HydroPICC 4F Single Lumen Catheter is comprised of a radiopaque hydrophilic catheter material with a suture wing, Luer lock hub, and extension tubing made from materials commonly used in the manufacture of catheters are provided packaged in kit configurations with the appropriate accessories for placement in the respective clinical environments. The maximum power injection flow rate for the lumen is indicated on the clamp. HydroPCC has been shown to be effective in reducing thrombus accumulation and thrombotic occlusions f thrombus accumulation and thrombotic occusions were evaluated using in vitro and in vivo models. Pre-clinical in vivo evaluations do not necessarily predict clinical performance with respect to thrombus formation.

The Piccolo Medical PM2™ System with ECGuide™ Connector is indicated for the positioning of central venous catheters including PICCs. It provides catheter tip location information by using the patient's cardiac electrical activity. The PM2™ System with ECGuide™ Connector is indicated for use as an alternative method to chest x-ray or fluoroscopy for confirmation of central venous catheter tip placement in adult patients. Note: In general, devices that utilize ECG technique to observe P-wave are limited, but not contraindicated. for patients where cardiac rhythms may change presentation of the P-wave; including -Atrial fibrillation -Atrial flutter -Severe tachycardia -Pacemaker-driven rhythm -Chronic obstructive pulmonary disease (COPD) Such patients are easily identified prior to central catheter insertion. In these specific cases, use of an additional confirmation method is necessary to confirm catheter tip location.

The PM2™ System and ECGuide™ Connector is a device used by clinicians for bedside tip location confirmation of central venous catheters. The PM2™ System and ECGuide™ Connector provide real-time catherer tip location information by using intravascular ECG (ivECG). The ECGuide™ Connected to the distal lumen hub of a CVC and primed with saline to create an ivECG electrode at the distal tip of the catheter and allow for ECG catheter tip confirmation. The EGuide™ Connector is used only during CVC installation, and removed once the CVC tip position is confirmed to be at the target location. The ECGuide™ Connected to the PM2 system which processes, displays, and stores the ECG waveforms.

The CATHTONG III Tapered PICC Catheter is intended for short or long-term peripheral access to the central venous system for infusion, intravenous therapy, blood sampling, power injection of contrast media, the administration of fluids, medications and nutrients, and allows for central venous pressure monitoring. The maximum recommended infusion rate is 5.0 mL/sec for the 4F single lumen catheters and the 5F dual lumen catheters. The maximum pressure of power injection with the CATHTONG III Tapered PICC Catheter may not exceed 325 psi. The CATHTONG III Tapered PICC Catheter is indicated for adult patients.

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The L-Cath Single and Dual Lumen Catheters and the L-Cath Midline Catheters are indicated for short or long term peripheral access to the central venous system for the administrations, and nutrients; the sampling of blood; and monitoring blood pressure and temperature intravenously.

The L-Cath™ Single and Dual Lumen and L-Cath™ Midline Catheters are sterile, single use devices, sold as standalone devices which includes the following accessories: • Trim Tool • Tape measure • Stylet (include in the final catheter assembly as applicable) • Polyurethane catheter These catheters are also sold as a component in a Basic Kit (catheter and introducer packaged together) which includes the following: - BD Introsyte Autoguard Introducer or Splittable Introducer ● - Stylet (include in the final catheter assembly as applicable) - Trim Tool - Tourniquet - Tape measure

The CATHTONG™ II PICC Catheter is intended for short or long-term peripheral access to the central venous system for infusion, intravenous therapy, blood sampling, power injection of contrast media, the administration of fluids, medications and nutrients, and allows for central venous pressure monitoring. The maximum recommended infusion rate is 5.0 mL/sec for 4F single lumen catheters. The maximum pressure of power injection with the CATHTONG™ II PICC Catheter may not exceed 325 psi. The CATHTONG™ II PICC Catheter is indicated for adult patients.

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The CATHTONG™ II PICC Catheter is intended for short or long-term peripheral access to the central venous system for infusion, intravenous therapy, blood sampling, power injection of contrastration of fluids, medications and nutrients, and allows for central venous pressure monitoring. The maximum recommended infusion rate is 5.0 mL/sec for 5F dual lumen catheters. The maximum pressure of power injection with the CATHTONG™ II PICC Catheter may not exceed 325 psi. The CATHTONG™ II PICC Catheter is indicated for adult patients.

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