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The Mahurkar 13.5 Fr Cuffed Catheter with curved extensions is intended to be used as an acute or chronic central venous access device for hemodialysis, apheresis, and infusion. The Mahurkar 13.5 Fr Cuffed Silicone catheter is designed for acute and chronic hemodialysis, apheresis, and infusion. It may be inserted either percutaneously or by cutdown.

The Mahurkar 13.5 Fr Cuffed Catheter with curved extensions is a radiopaque silicone tube with two D-shaped lumina. The lumina can be distinguished by the color-coded luer-lock adapters on the clear silicone rubber extensions: the red adapter indicates the proximal lumen, and the blue adapter indicates the distal lumen. During hemodialysis and apheresis, the proximal lumen provides "arterial" outflow from the patient and the distal lumen provides "venous" return. The Mahurkar 13.5 Fr Cuffed Catheter with curved extensions is available in four (4) implantable lengths (36 cm, 40 cm, 45 cm, and 50 cm), and will be packaged in single, catheter kit and catheter tray configurations.

The Monoject™ Blunt I.V. Access Cannula is a sterile, lubricated plastic cannula with a female luer hub. It is used to provide access to pre-pierced IV line injection sites and pre-pierced medication vials.

The Monoject™ Blunt I.V. Access Cannula is a sterile, lubricated plastic cannula with a female luer hub. It is used to provide access to pre-pierced IV line injection sites and pre-pierced medication vials. The Monoject™ Blunt I.V. Access Cannula will be available in the following configurations: Individual Blunt Cannula; Blunt I.V. Access Cannula attached to piston syringe of 3 ml, 6ml and 12 ml sizes.

The Sensi-Touch™ Combo Spinal/Epidural Regional Anesthesia Delivery System will include all components commonly required to perform both a spinal and epidural procedure in a sterile, single use procedure-ready package. This procedure tray will be available in several configurations of tray components. This device is a Class II device per 21 CFR 868.5140, Procode: 73CAZ. The combo tray is intended for Surgical or OB regional anesthesia blocks.

The Sensi-Touch™ Combo Spinal/Epidural Regional Anesthesia Delivery System will include all components commonly required to perform both a spinal and epidural procedure in a sterile, single use procedure-ready package. This procedure tray will be available in several configurations of tray components. This device is a Class II device per 21 CFR 868.5140, Procode: 73CAZ. The combo tray is intended for Surgical or OB regional anesthesia blocks. The rational for combining the epidural and spinal needles into one kit is as follows; an epidural block takes approximately 25 minutes for onset of the anesthetic, whereas, a spinal block takes approximately 5 min. for onset of Therefore, the patient benefits from both quick pain anesthetic. relief associated with a spinal and long-term pain relief associated with an epidural. The procedure is as follows, the clinician will first place the epidural needle in the patient's epidural space. The spinal needle is then inserted through the epidural needle into the spinal cavity. The anesthetic is then administered through the spinal needle for quick pain relief. The spinal needle is then removed and an epidural catheter is inserted through the epidural needle into the epidural space. The catheter provides a conduit for the administration and re-administration of anesthetic into the epidural space to provide long term pain relief.

The Neonatal/Pediatric Thoracic Catheter is a sterile, single use indwelling catheter, used to create a patent open passageway between the chest cavity and atmosphere or a Chest Drainage Unit (CDU). The catheter is intended to prevent pressure from developing in the chest, averting lung collapse and providing a means for fluid to drain from the chest cavity.

The Argyle Turkel Neonatal/Pediatric Thoracic Catheter Insertion Tray will include all components commonly required to perform a chest drainage procedure in a single procedure-ready package. This procedure tray will be available in several configurations of tray components. The Neonatal/Pediatric Thoracic Catheter is a sterile, single use indwelling catheter, used to create a patent open passageway between the chest cavity and atmosphere or a Chest Drainage Unit (CDU). The catheter will be available in 8, 10 and 12 fr sizes. The device incorporates a blunt, multi-sideholed, springloaded inner cannula coaxially housed within a conventional sharp-beveled hollow needle. This entire assembly is housed within polyurethane tapered catheter, which is used as a standard small bore percutaneously placed thoracic catheter. The tapered catheter incorporates four distal side-holes to facilitate drainage.

The Kangaroo® EntriStar Jejunal Feeding System is substantially equivalent to the BioSearch Dobbhoff GastroTrac Jejunal Feeding Tube (K900590), and the BioSearch Dobbhoff GastroTrac Jejunal Feeding System, (K900624), both currently manufactured by BioSearch and distributed by Sherwood Medical. Sherwood Medical Company will manufacture this product line. The intended uses and components of the of Kangaroo Jejunal Feeding System are identical to the BioSearch Dobbhoff GastroTrac Jejunal Feeding Tube and System.

The Kangaroo Jejunal Feeding System is comprised of a gastrostomy tube and a jejunal feeding tube. The gastrostomy tube is identical to the BioSearch gastrostomy tube, and is a Foley-type of catheter. It is a dual lumen catheter with a retention balloon and outlet port at the the distal end. The proximal end has a female luer balloon inflation valve and an outlet adapter. The Gastrostomy Tube allows access to the jejunum by the Kangaroo Jejunal Feeding Tube. It is ethylene oxide sterilized to an SAL of 106. The Jejunal feeding tube is included with the system, and may also be packaged and sold separately. It consists of a polyetherbased polyurethane and will be available in lengths ranging from 18" to 36", and in a range of tube diameters from 6 to 12 French.

The function of the stylet is to provide the necessary stiffness to aid the clinician in the placement of a nasointestinal feeding tube.

The Kangaroo® Stylets are comprised of a stainless steel wire that terminates at its distal end welded to an atraumatic stainless steel spring. The proximal end of the stainless stylet wire is mechanically attached to a flow-through male polypropylene luer hub.

The device is intended to be used in critical care units to aspirate secretions from patient airways who have endotracheal or tracheostomy tubes and require mechanical ventilation. The system allow for the insertion and withdrawal of a suction catheter into the artificial airway without disconnecting the patient from the ventilator circuit. The components of this system are sterile, single patient use, and disposable.

The Argyle® ASPR-Care™ Closed Suction System consists of three discreet components: a dual swivel T-piece, a sheathed suction catheter, and a suction control valve. When connected together, these components form a closed system suction catheter similar in form and function to the closed system catheters available from Ballard and Concord/Portex.

The Kanqaroo® EntriStar™ Skin-Level Gastrostomy Kit is a sterile, single use device containing a gastrostomy tube and the components needed to insert a low profile qastrostomy tube. The Kangaro® Skin-Level Gastrostomy Kit is a Class II device, Gastrointestinal Tube and Accessories per 21 CFR 876.5980, Procode: 78KNT. The Skin-Level Gastrostomy Tube is a replacement gastrostomy tube placed through an existing stoma via the abdomen into the stomach. The tube acts as a conduit to deliver formula to a patient requiring enteral nutrition and as conduit for insertion of enteral access devices such as qastric a decompression catheters or intestinally placed feeding catheters.

The Kanqaroo® EntriStar™ Skin-Level Gastrostomy Kit is a sterile, single use device containing a gastrostomy tube and the components needed to insert a low profile qastrostomy tube. The Kangaro® Skin-Level Gastrostomy Kit is a Class II device, Gastrointestinal Tube and Accessories per 21 CFR 876.5980, Procode: 78KNT. The Skin-Level Gastrostomy Tube is a replacement gastrostomy tube placed through an existing stoma via the abdomen into the stomach. The tube acts as a conduit to deliver formula to a patient requiring enteral nutrition and as conduit for insertion of enteral access devices such as qastric a decompression catheters or intestinally placed feeding catheters. The stoma tube is designed so that it is a fixed length to correspond to the depth of the stoma. However, a "step-up shim" may be placed between the external retention device and the abdominal wall to customize the fit to the patient. The Skin-Level Gastrostomy Tube is inserted and removed by inserting the obturator through the inner lumen of the stoma tube. When inserted, the obturator mechanically slenderizes (elongates) the internal retention device, which reduces its diameter to reduce the physical trauma to the stoma inherent in the insertion and removal procedures. The Skin-Level Gastrostomy Tube is available in various lengths designed to precisely fit the depth of the patient's stoma, which results in a snuq fit between the surface of the external retention device and the patient's abdomen. An insertion/removal accessory is included for use when inserting and removing the gastrostomy tube. The distal tip of the obturator and the internal retention device are covered in lubricous Hydromer coatinq to reduce the force needed to insert the obturator and qastrostomy tube. Hydromer coating is currently used in several nasoqastric feeding tubes marketed by Sherwood and Biosearch Medical Products which were cleared via the 510(k) process.