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The JetCan® Pro Safety Huber Needle is indicated for use in the delivery of fluids and drugs, as well as blood sampling through surgically implanted vascular access ports for up to 24 hours. It is compatible with power injection ports and associated power injection procedures up to 325 psi. The JetCan® Pro Safety Huber Needle incorporates a passive safety mechanism, activated upon the withdrawal from a port catheter to aid in the prevention of accidental needle sticks and minimize exposure to hazardous fluids.

The JetCan® Pro Safety Huber Needle is a non-coring Huber needle used to access the septum of a surgically implanted vascular access port for the delivery of intravenous fluids, blood sampling and power injection of contrast media, up to 5 mL/s at 325 psi. The JetCan® Pro Safety Huber Needle is a single use, external communicating device, with direct blood contact and a duration of use of less than or equal to 24 hours.

The ASEPT Glide Peritoneal Drainage System is indicated for intermittent, long-term drainage of symptomatic, recurrent, malignant and non-malignant ascites that does not respond to medical management of the underlying disease and for the palliation of symptoms related to recurrent ascites. The use of the ASEPT Glide Peritoneal Catheter for non-malignant ascites is limited to patients who are intolerant or resistant to maximum medical therapy, refractory to large volume paracentesis (LVP) and are not candidates for trans-juqular intrahepatic portosystemic shunt or LVP. The ASEPT Glide Peritoneal Catheter is indicated for adults only.

The ASEPT Glide Peritoneal Drainage System provides patients with a method to drain accumulated fluid from the abdomen. The primary components of the system are the indwelling ASEPT Glide Peritoneal Catheter and the ASEPT Drainage Kit. The catheter is placed in the patient's peritoneal cavity enabling the patient to perform periodic peritoneal drainage at home or in the hospital. The device is provided sterile. The ASEPT Glide Peritoneal Drainage Catheter has a surface modification applied from the distal tip to the polyester cuff.

The ASEPT Peritoneal Drainage System is indicated for intermittent, long-term drainage of symptomatic, recurrent, malignant and non-malignant ascites that does not respond to medical management of the underlying disease and for the palliation of symptoms related to recurrent ascites. The use of the ASEPT Peritoneal Catheter for non-malignant ascites is limited to patients who are intolerant or resistant to maximum medical therapy, refractory to large volume paracentesis (LVP) and are not candidates for a trans-jugular intrahepatic portosystemic shunt or LVP. The ASEPT Peritoneal Catheter is indicated for adults only.

The ASEPT Peritoneal Drainage System provides patients with a method to drain accumulated fluid from the abdomen. The primary components of the system are the indwelling ASEPT Peritoneal Catheter and the ASEPT Drainage Kit. The catheter is placed in the patient's peritoneal cavity enabling the patient to perform periodic peritoneal drainage at home or in the hospital.

The NuCath™ Wedge Pressure Catheter is indicated for measuring pressure in the right heart (including central venous pressure, right ventricle pressure, pulmonary artery pressure, and pulmonary artery wedge pressure).

The NuCath Wedge Pressure Catheter is an intravascular catheter with a balloon at the distal tip intended to measure pressure in the right heart.

The ASEPT® Surgical Face Mask is indicated as a protective nose and mouth covering for healthcare workers and patients involved in medical and surgical procedures. The masks are indicated in any procedure or situation where there is a risk of exposure to microorganisms and body fluids.

ASEPT® Surgical Face Mask is a single-use, three layer, flat-folded mask with ear loops and nose piece. The inner and outer layers are constructed of spun-bond polypropylene and the middle layer is constructed of melt blown polypropylene filter. The mask is held in place over the mouth and nose by two elastic loops welded to the facemask. The elastic loops are not made with natural rubber latex. The nose piece is made of malleable polyethylene with aluminum wire and allows the user to fit the facemask around their nose. The ASEPT® Surgical Face Mask is sold non-sterile and is intended to be a single use, disposable device.

The primeMIDLINE™ Catheters are indicated for short term access to the peripheral venous system for selected intravenous therapies, blood sampling and power injection of contrast media. These catheters are indicated for patients older than 28 days and that weigh more than 10 kg, with consideration given to adequacy of vascular anatomy and appropriateness of the procedure. The primeMIDLINE™ Catheters are suitable for use with power injectors.

The 4F DL primeMIDLINE™ Catheter is a peripherally placed midline catheter designed to provide access to the vascular system. The catheter lumen is an open-ended design comprised of radiopaque polyurethane. The 4F DL primeMIDLINE ™ Catheter is packaged sterile in a tray with the accessories necessary to establish short-term (less than 30 days) vascular access. The 4F DL primeMIDLINE Catheter is suitable for use with power injectors.

The primeMIDLINE™ Catheters are indicated for short term access to the peripheral venous system for selected intravenous therapies, blood sampling and power injection of contrast media. These catheters are indicated for patients older than 28 days and that weigh more than 10kg, with consideration given to adequacy of vascular anatomy and appropriateness of the procedure. The primeMIDLINE™ Catheters are suitable for use with power injectors.

The primeMIDLINE™ Catheters are a family of peripherally placed midline catheters designed to provide access to the vascular system. These catheters are offered in 3F, 4F and 5F Single Lumen and 5F Dual Lumen configurations with 20cm lengths. The catheter lumen is an open-ended design comprised of radiopaque polyurethane. Each primeMIDLINE™ Catheter is packaged sterile in a tray with the accessories necessary to establish short-term (less than 30 days) vascular access. The primeMIDLINE™ Catheters are suitable for use with power injectors.

The Safety Biopsy Needle System (Safety Biopsy Needle and Safety Coaxial Needle with Finger Guard) is intended to be used for soft tissue and tumor biopsy of such organs as the liver, spleen, kidney, prostate, lung, breast, and lymph nodes. When used for breast biopsy, the product is for diagnosis only. The extent of histological abnormality cannot be reliably determined from its mammographic appearance. Therefore, the extent of removal of the imaged evidence of an abnormality does not predict the extent of removal of a histological abnormality; e.g., malignancy. When sampled abnormality is not histologically benign, it is essential that the tissue margins be examined for completeness of removal of using standard surgical procedures.

The Safety Biopsy Needle System consists of two main components: The Safety Biopsy Needle and the Safety Coaxial Needle with Finger Guard. The Safety Biopsy Needle is composed of two primary assemblies: the biopsy needle and the safety mechanism. The material used to manufacture both the biopsy needle and the safety mechanism is polycarbonate. The needle sheath is made of polyethylene. The available gauges for the safety biopsy needle ranges in size from 14 to 20, with lengths ranging up to 20 centimeters. The Safety Coaxial Needle with Finger Guard is composed of two primary assemblies, the coaxial needle cannula and the stylet. The material used to manufacture the assembly and introducer cannula, and for trocar stylet, is stainless steel. The needle sheath is made of polyethylene. The available gauges for the safety coaxial needle with finger guard ranges in size from 15 to 19, with lengths ranging up to 17 centimeters. The Safety Biopsy Needle System is sterilized via Ethylene Oxide (EtO) and is designed for single use only.

The Low Profile Port is indicated for patient therapies requiring repeated access to the vascular system. The port system can be used for infusion of medications, IV fluids, parenteral nutrition solutions, blood products and for the withdrawal of blood samples. When used with a power injectable needle, the Low Profile Port is indicated for power injection of contrast media. For power injection of contrast media, the maximum recommended infusion rate is 3 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 Low Profile Port is an implantable device designed to provide repeated access to the vascular system without the trauma associated with multiple vena puncture. The system consists of a self-sealing injection port and a delivery catheter for the receipt and delivery of medications to the selected body site. The Low Profile Port has a polyoxymethylene body, with or without a titanium insert and a silicone septum. The base of the port has the letters "CT" to signify that it can be used for power injection on contrast agents. These letters can be visualized through a Scout CT. The lot number is laser etched into the base of the port. The port can be anchored with sutures in the port pocket for secure seating. The suture holes may contain clear silicone to prevent tissue in growth to the suture holes. The Low Profile Port is offered with the polyurethane catheter either pre-attached by the manufacturer or attachable for application by the inserting physician. The catheter lock provides securement of the catheter to the port. Introduction of solution into the implanted port and catheter system is through a non-coring needle. Power injection of contrast media, can be safely administered with a 19 or 20 gauge power injectable infusion non-corning needle at a maximum recommended infusion rate of 3ml/sec or a 22 gauge power injectable non-coring needle at a maximum recommended infusion rate of 2 ml/sec. Maximum pressure should not exceed 300 psi. The Low Profile Port is packaged with the necessary accessories to facilitate catheter insertion. The port and catheter uses the same components and are manufactured and sterilized at the same manufacturing and sterilization facilities as the predicate device cleared under K072481. The power injection capability is comparable to the currently marketed Jet Port Plus HP Catheter cleared under K072481. Components will be assembled into standard configurations or configurations specified by the customer and packaged. • Implantable Port • Click Connector • Guide Wire • Dilator • Tunneling Needle • Vein Lifter • Introducing Needle • Peel Away Sheath • Syringe • Catheter • Huber Needle • Instructions for Use • Nurses' Guide • Companion Checklist • Patient Guide • Patient Chart Sheet • Patient ID Card and Key Ring Card

The Veta Peritoneal Dialysis Catheter is indicated for acute and chronic access to the peritoneal cavity. The Veta Peritoneal Dialysis Catheters will be used to drain and infuse fluid during peritoneal dialysis procedures.

Veta™ Peritoneal Dialysis Catheters are side-ported silicone catheters with a single and double retention cuff, available in a range of lengths and French sizes and in either a straight or spiral tip configuration.