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The Smiths Medical Peel-Away Sheath Introducers are indicated for the introduction of catheters into the vascular system. The Smiths Medical Peel-Away Sheath Introducers are indicated for the introduction of catheters into the subclavian vein.

Each Smiths Medical Peel-Away Sheath Introducer consists of a dilator and a peelable sheath. Both the dilator and the sheath have a hub at the proximal end. The dilator slides inside the sheath and the hubs are engaged so that sheath and dilator may be manipulated as a single unit. One version of the Smiths Medical Peel-Away Sheath Introducer has a valve on the proximal end of the hub. The introducers are available in French sizes ranging from 6 to 11. Interior diameters of the sheath range from .085 to .147 inches. Outside diameters range from .116 to .182 inches. The length of the dilator for the non-valved introducer is nominally 8 inches from hub to tip with a 6 inch sheath. The dilator for the valved introducer is 7 inches long with a 5 inch sheath. The Peel-Away Sheath Introducer is used to facilitate the insertion of a catheter into the vascular system by dilating a vessel and introducing the sheath. The hubs are then disengaged and the dilator is removed leaving the sheath through which a catheter may be inserted. The sheath hubs are then broken and the sheath is peeled away and removed from the catheter.

The Medfusion® Model 4000 Syringe Infusion Pump is indicated for the following uses: - . In the administration of fluids requiring precisely controlled infusion rates including blood or blood products. lipids, drugs, antibiotics, enteral solutions and other therapeutic fluids. - . By the following delivery routes: arterial, epidural, intrathecal, subcutaneous, and enteral. - . By the following delivery modes: continuous, volume/time, mass, body weight, custom dilution, intermittent and bolus. - . In critical care, anesthesia, neonatal and pediatric applications or other healthcare settings where the use of the syringe infusion pump can be monitored or supervised by a clinician. - . Inside the MRI room mounted outside the 150 Gauss line and with shielded magnets of field strength of 1.5 Tesla. The PharmGuard® Toolbox 2 Medication Safety Software is indicated to provide a vehicle to create and securely upload user-defined configuration parameters, a library of drug names and associated user-defined infusion parameters to Medfusion® Model 4000 Syringe Infusion Pump with software version 1.X. The PharmGuard® Toolbox 2 Medication Safety Software collects and downloads operational, infusion and alarm history events, library usage counts, and PharmGuard® safety events from the Medfusion® Model 4000 Syringe Infusion Pump. It is intended to provide a dataset users can collect and analyze to improve overall processes and lessen the likelihood of operator error when entering infusion parameters into the Medfusion® Model 4000 Syringe Infusion Pump. The PharmGuard® Supported Syringes is an accessory to the PharmGuard® Toolbox 2 Medication Safety Software that expands the available supported syringes that can be selected when creating user defined configuration parameters using the PharmGuard® Toolbox 2 Medication Safety Software.

The Medfusion® Model 4000 Syringe Infusion Pump software version 1.1 is a wireless capable electro-mechanical syringe infusion pump. The PharmGuard® Toolbox 2 Medication Safety Software is designed to accommodate the features and capabilities of the 4000 pump with software version 1.X.

This product is indicated for the administration into or withdrawal of fluids from implanted ports. It is designed to help protect against accidental needlestick injuries.

The GRIPPER® Micro needle is comprised of the inserter and the infusion site with extension tubing and a standard luer fitting; there are versions either with or without needless access connector y-site. The inserter incorporates a sharp trocar needle and retractor arm. The infusion site incorporates a small septum and an attached blunt cannula. When fully assembled, the inserter and infusion site are combined with the trocar needle inserted through the septum and blunt cannula. After insertion of the cannula and trocar into the implanted port, the inserter retractor arm is activated removing the trocar needle from the cannula and infusion site septum leaving the blunt cannula in the implanted port. The trocar needle tip is captured in the inserter to prevent needle stick injury, and the inserter is discarded. Upon removal of the infusion site from the implanted port, the blunt cannula is designed to further prevent needle stick injury that may result from rebounding action during infusion site extraction.

The Lockbox is intended to hold a Medfusion™ 3000 Series Syringe Pump and provide reasonably secure access to the medication syringe contained within.

The Lockbox is an accessory to the Medfusion™ 3000 Series Syringe Pump. It is a lockable, plastic enclosure for the pump when the pump is loaded with a commercially available syringe containing medication. The Lockbox may be attached to an IV pole with the Pole Mount Bracket or with modification to a horizontal square rail.

The CADD® -Solis Medication Safety Software - Administrator allows use of a computer to create therapy based protocol libraries to be used with the CADD®-Solis Ambulatory Infusion Pump or CADD-Prizm® PCS II Ambulatory Infusion Pump (software revision H or higher). The CADD"-Solis Medication Safety Software -- Point of Care allows use of a computer to send therapy-based protocols developed by the CADD® -Solis Medication Safety Software -Administrator to the CADD®-Solis Ambulatory Infusion Pump and CADD-Prizm® PCS II Ambulatory Infusion Pump (software revision H or higher).

The Smiths Medical MD, Inc. CADD® -Solis Medication Safety Software, a software program that operates on commercially available personal computers or similar hardware platforms such as tablets, is designed for pump programming of the CADD -Solis Planorms such as lables, is designed for pains programming so managers infusion Pump (software revision H or higher) through a therapy-based protocol database defined by the user. The CADD®-Solis Medication Safety Software consists of an Administrator and a Point-of-Care (POC) software module that employs serial communications to send and receive pump information. Both modules are compatible with barcode scanners (or similar input devices) through various PC connections. Barcode format is determined by the user; but is limited to 20 alphanumerical characters. The CADD®-Solis Medication Safety Software does not allow duplicative Drug, Protocol or User identification entries. The CADD®-Solis Medication Safety Software – Administrator module allows the user to create, cdit, and save therapy-based protocols and pump settings within user-defined protocol libraries. The Administrator user determines POC user access and library editing capabilities. Other Administrator module features include barcode printing, reports, and sending and receiving pump information. The CADD®-Solis Medication Safety Software – Point of Care module allows the user to download therapy based protocols to the CADD® Solis Ambulatory Infusion Pump and CADD-Prizm® PCS II Ambulatory Infusion Pump (software revision H or higher) and send and receive pump settings via serial communication. Additional features include storing and printing pump program settings and reports, verifying pump settings to established protocols and viewing history logs in the easier view of a PC monitor.

The CADD™ Medication Cassette reservoirs are intended for the delivery of medications and fluids for subcutaneous, intramuscular, intravenous, intra-arterial, intraperitoneal, or intraspinal infusion.

The CADD™ Medication Cassette Reservoir with Flow Stop feature is a modification to the current CADD™ Medication Cassette Reservoir with Flow Stop. The modification incorporates a 250 mL reservoir and a two-part housing assembly. It is provided with a medication bag and pump tube, extension tube, pressure plate with Flow Stop feature, rear housing, clamp and leur assembled with the cover set into the rear housing assembly but not snapped together. This two-part housing design is intended to allow manipulation of the medication bag for removal of air bubbles prior to permanently snapping the housing together.

The LockBox is a plastic enclosure designed to hold a CADD®-Solis infusion pump and a medication reservoir or syringe.

The LockBox is an accessory to the CADD® -Solis ambulatory infusion pump. It is a plastic enclosure for the CADD®-Solis ambulatory infusion pump when it is attached to commercially available medication rescrvoir. The reservoir may be a flexible IV bag up to 500 mL in size or a syringe up to 60 mL. The Lockbox may be attached to a CADD-Prizm Polcmount Bracket.

The CADD -Solis ambulatory infusion pump is indicated for intravenous, intraarterial, subcutaneous, intraperitoneal, in close proximity to nerves, into an intraoperative site (soft tissue, body cavity/surgical wound site), epidural space, or subarachnoid space infusion. The pump is intended for therapies that require a continuous rate of infusion, patient-controlled demand doses, or both (such as patientcontrolled analgesia). The CADD®-Solis Medication Safety Software consists of the Administrator and the Point of Care software applications. This software allows you to create a set of standard pump Protocols to be used with the CADD®-Solis Ambulatory Infusion Pump and CADD-Prizm® PCS II Ambulatory Infusion Pump. The Point of Care software application is used for the CADD-Prizm® PCS II Ambulatory Infusion pump (with software revision H or higher) only.

The CADD® -Solis ambulatory infusion pump ("Solis Pump") provides measured drug therapy to patients in the hospital setting. The pump can be programmed to deliver medication at a continuous rate, patient controlled analgesia (PCA), clinician bolus, continuous rate plus PCA, and continuous rate plus clinician bolus. The Smiths Medical MD, Inc. CADD® -Solis Medication Safety Software -Administrator ("Solis Safety Software - Administrator"), a server based software program that operates on commercially available computers, is designed to establish user defined therapy based protocols for use by the Solis Pump or for use by use CADD®-Solis Medication Safety Software – Point of Care (POC) to program the CADD-Prizm® PCS II Ambulatory Infusion Pump (software revision H or higher). The Solis Safety Software - Administrator does not allow duplicative Drug, Protocol or User identification entries.

The CADD-Sentry Pro"" Medication Safety Software – Administrator allows you to establish a therapy-based protocol library that will be used by the CADD-Sentry Pro Medication Safety Software - Point of Care to program the CADD-Prizm® PCS II Ambulatory Infusion Pump (software revision H or higher). The CADD-Sentry Pro" Medication Safety Software – Point of Care allows use of a personal computer to send CADD-Sentry Pro "Medication Safety Software --Administrator established therapy-based protocols to the CADD-Prizm® PCS II Ambulatory Infusion Pump (software revision H or higher).

The Smiths Medical MD, Inc. CADD-Sentry Pro™ Medication Safety Software, a software program that operates on commercially available personal computers or similar hardware platforms such as tablets, is designed for pump programming of the CADD-Prizm" PCS II Ambulatory Infusion Pump (software revision H or higher) through a therapy-based protocol database defined by the user. The CADD-Sentry Pro™ Medication Safety Software consists of an Administrator and a Point-of-Care (POC) software module that employs serial communications to send and receive pump information. Both modules are compatible with barcode scanners (or similar input devices) through various PC connections. Barcode format is determined by the user; but is limited to 20 alphanumerical characters. The CADD-Sentry Pro™ Medication Safety Software does not allow duplicative Drug, Protocol or User identification entries. The CADD-Sentry Pro™ Medication Safety Software - Administrator module allows the user to create and save therapy-based protocols, including pump settings. The Administrator module allows therapy-based protocols to be stored and edited within user-defined protocol libraries. The Administrator user determines POC user access and editing capabilities of these libraries. Other Administrator module features include barcode printing, reports, and sending and receiving pump identification. The CADD-Sentry Pro™ Medication Safety Software - Point-of-Care module allows the user to send and receive pump settings via serial communication sourced from protocol libraries established using the Administrator module. Additional features include storing and printing pump programs and reports, verifying pump settings to established protocols and viewing history logs in the easier view of the PC monitor.

POWER P.A.C. Implantable Venous Access Systems: The POWER P.A.C. implantable venous access systems are implantable vascular access devices designed to provide long term repeated access to the vascular system. Smiths Medical MD, Inc. POWER P.A.C. Implantable Venous Access Systems are indicated when patient therapy requires repeated vascular access for injection or infusion therapy and/or venous blood sampling. When used with a GRIPPER PLUS® POWER P.A.C. Safety Huber Needle or other power injectable huber needle, the Smiths Medical MD, Inc. POWER P.A.C. implantable venous access systems are indicated for power injection of contrast media. For power injection of contrast media. the maximum recommended infusion rate is 5 ml/sec. GRIPPER PLUS® POWER P.A.C. Needle: The GRIPPER PLUS® POWER P.A.C. Safety Huber Needle is designed for the administration into or withdrawal of fluids from implanted ports. The GRIPPER PLUS® POWER P.A.C. Safety Huber Needle is indicated for the administration into or withdrawal of fluids from implanted ports. It is designed to help protect against exposure to bloodborne pathogens caused by accidental needlestick injuries. When used with power injectable implantable venous access ports, the GRIPPER PLUS® POWER P.A.C. Safety Huber Needle is indicated for power injection of contrast media.

POWER P.A.C. Implantable Venous Access Systems: The POWER P.A.C. implantable venous access systems are similar to the current PORT-A-CATH® and PORT-A-CATH® II implantable venous access systems and Power Injectable Implantable Infusion Port. They both are totally implantable venous access systems designed to permit repeated access to the venous system for the parenteral delivery of medications, fluids, nutritional solutions, and for the sampling of venous blood. However, when used with a power indicated huber needle, the POWER P.A.C. implantable venous access systems are indicated for power injection of contrast media. The POWER P.A.C. implantable.vanous access systems can be placed in the chest or arm. The POWER P.A.C. implantable venous access systems are supplied sterile and non-pyrogenic. All POWER P.A.C. implantable venous access systems are designed and intended for single patient use only. A system consists of a portal with one or two self-sealing septa and a single or dual lumen catheter and is accessible by percutaneous puncture with a non-sopina neede. GRIPPER PLUS® POWER P.A.C. Needle: The GRIPPER PLUS® POWER P.A.C. Needle is similar to the current GRIPPER PLUS® needle, with the addition of an added indication. Both are supplied sterile and non-pyrogenic and are intended for the administration into or withdrawal of fluids from implanted ports. In addition, they both have a passive needle stick protection feature that is designed to help protect against exposure to bloodborne pathogens caused by accidental needlestick in its protection in help not protect against other routes of bloodborne pathogen transmission. The GRIPPER PLUS® POWER P.A.C. Needle is indicated for power injection of contrast media.