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The ambIT PCA*PIB Pump is used to infuse medicines and/or fluids into patients primarily for pain management. The routes of administration are generally intravenous, epidural and/or regional. The ambIT PCA*PIB Pump is not intended to supersede, augment, or replace any other medical device or drug indications for use or intended uses. The ambIT PCA*PIB Pump is intended to be used in the home and in healthcare facilities.

The new ambIT PCA*PIB is an electro-mechanically controlled, rotary-peristaltic, infusion pump that consists of two components: (1) the reusable pump driver; and (2) the sterile, single-use cassette (tubing set). The ambIT PCA*PIB Pump has a microprocessor-controlled motor that turns the rollers in the cassette at a set frequency to provide the desired infusion rate/therapy. The ambIT PCA*PIB Pump is powered by two (2) standard 1.5-volt "AA" batteries, and cannot be powered by electrical mains. The batteries are replaceable but cannot be recharged inside the pump. The controls consist of two buttons and an OFF/ON switch. One button toggles the pump between pause and infusing. The other button (BOLUS button) is used to request a bolus. An LCD display shows the pump status, alarms, and history. The pump monitors downstream occlusions, pump malfunctions, and other pump error conditions. The materials of construction are all medical grade plastics. Specifically, the materials are ABS, polycarbonate, nylon, and glass-filled nylon. The part of the pump that comes into indirect contact with the body is the cassette or tubing set. The medications flow through the tubing into a catheter and then into the body. The tubing set is classified to be used for less than 30 days. The length of time the pump is used is based on the therapy requirements. The ambIT PCA*PIB product has been validated and verified to meet healthcare providers', lay users', and patients' needs for pain management infusions. The pump meets all applicable national and international consensus standards.

CADD®- Solis Ambulatory Infusion Pump with Wireless Communication CADD®-Solis Infusion Pump, Model 2110 The CADD®-Solis Pump is indicated for intravenous, intra-arterial, subcutaneous, intraperitoneal, in close proximity to nerves, into an intraoperative site (soft tissue, body cavity/surgical wound site), epidural space. The pump is intended for therapies that require a continuous rate of infermittent bolus, and/or with patientcontrolled demand doses. PharmGuard® Administrator Medication Safety Software The PharmGuard® Administrator Medication Safety Software allows the use of a computer to create therapy-based protocol libraries to be used with the CADD®-Solis Infusion Pump. CADD® Administration Set The CADD® Administration Set is designed for use with the CADD® Infusion pumps (except CADD®-Micro) to allow medication delivery from a flexible container. Wireless Communication Module (CM) The Wireless Communication Module is intended to be used as an accessory to provide wireless capability and battery power to a CADD®-Solis Infusion Pump, Model 2110

The CADD®- Solis Ambulatory Infusion Pump with Wireless Communication, which includes the CADD®-Solis Infusion Pump, Model 2110, the Wireless Communication Module (CM), and the PharmGuard® Administrator Medication Safety Software, work together to provide wireless communication between the pump and the server and are similar to currently marketed products. The CADD®-Solis Infusion Pump, Model 2110 has a microprocessor and linear peristaltic pumping mechanism, similar in design to the Smiths Medical ASD, Inc. CADD®-Solis Ambulatory Infusion Pump, Version 3.0 (K130394). The user activates CADD®-Solis Infusion Pump, Model 2110 via a color LCD screen and keypad user interface. Commands are issued to the microprocessor by activating the user interface. Microprocessor actions are controlled by a program, which is contained in the pump's memory. The CADD® Administration Set is designed for use with the CADD® Infusion pumps (except CADD®-Micro) to allow medication delivery from a flexible container. The Flow Stop feature is a set-based free flow protection component (i.e. Flow Stop) that is designed to occlude the tube if the set is accidentally placed onto the pump incorrectly or becomes detached from the pump. The Flow Stop is located on the set housing, which is attached to the pump.

The LifeCare PCA™ infusion system is intended for intravenous or epidural administration of analgesic medications that are delivered by a continuous rate of infusion and/or with patient-controlled demand doses.

The Hospira LifeCare PCA™ Infusion System is a microprocessor controlled, pole mounted, electromechanical infusion pump that allows a patient to self-administer analgesic using an attached patient pendant, within physician prescribed, programmed parameters. The Hospira LifeCare PCA™ Infusion System also includes a sterile empty vial that can be pharmacy-filled with appropriate medications, and dedicated administration sets to administer the medication. The infuser is powered from an AC power source and has an internal battery to maintain operation for short periods when an AC power source is not available. A stepper motor exerts pressure on an inserted drug vial to control the infusion of analgesic into a patient. The infuser will accept either a pre-filled drug vial manufactured by Hospira or a sterile empty vial that can be filled by a hospital's pharmacy. Administration Sets compatible for use in the LifeCare PCA™ Infuser are provided sterile (fluid path) and intended for single-use application. The infuser is equipped with wireless (802.11 a/b/g) and wired interfaces to Hospira MedNet™ Software. Drug Libraries and Auto-Programs are transferred using these interfaces. The subject device bi-directionally communicates to the hospital information system through the Hospira MedNet™ Server, which is optional software, and the device can also be programmed and used without the Hospira MedNet™ software.

The CADD® -Solis Ambulatory Infusion Pump, Model 2110, Version 3.0, is indicated for intravenous, intra-arterial, 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, and/or an intermittent bolus, and/or with patient-controlled demand doses. 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 VIP Ambulatory Infusion Pump, 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 CADD® -Solis Ambulatory Infusion Pump, Model 2110, Version 3.0 ("CADD"-Solis Version 3.0 Pump") has a microprocessor and linear peristaltic pumping mechanism, similar in design to the Smiths Medical ASD, Inc. CADD®-Solis Ambulatory Infusion Pump, Version 1.0 (K072144) and CADD -Solis VIP Ambulatory Infusion Pump, Version 2.0 (K111275). The user activates CADD® Solis Version 3.0 Pump via a color LCD screen and keypad user interface. Commands are issued to the microprocessor by activating the user interface. Microprocessor actions are controlled by a program, which is contained in the pump's memory. The CADD®-Solis Version 3.0 Pump consists of components, such as the user interface, sensors, communication ports, power ports, structural (housing) components, electronics, pumping mechanism, watchdog timer, pump battery and circuitry, real time clock, onboard memory, and pump log. The CADD® Solis Version 3.0 Pump exterior surface components include the pump housing, LCD lens, labels, and keypad, and the materials of construction for these components are widely used in the medical industry. The CADD -Solis Version 3.0 Pump is designed to be used with a CADD® Infusion Disposable, such as Medication Cassette Reservoir. The CADD™-Solis Medication Safety Software System consists of the Administrator and the Point of Care software applications. This software allows the user 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 Perfusor® Space Infusion Syringe Pump System is an electrical, external, syringe infusion pump system indicated for use with adults, pediatrics and neonates and is intended to provide infusions of parenteral fluids/medications, blood and blood products indicated for infusion through FDA approved routes of administration.

The Perfusor® Space Infusion Syringe Pump System includes an external transportable electronic syringe infusion pump and pump accessories. The Perfusor Space Infusion Syringe Pump System utilizes a swivel-drive pumping mechanism and is intended to provide infusions of parenteral fluids. The Perfusor® Space Infusion Syringe Pump System is intended to be used by trained healthcare professionals in healthcare facilities, home care, outpatient, and medical transport environments. A trained Biomedical Technician must perform a complete set-up of the pump prior to use in a clinical setting. The system is intended to provide intermittent or continuous flow of parenteral fluids to the patient. Parenteral fluids may include standard fluids and/or medications indicated for infusion as well as blood and blood products.

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 intended use of the Multirate Infusor with Patient Control Module includes slow, continuous, subcutaneous or epidural administration of pain medications. It may also include the slow, continuous infusion of pain medications directly into an intraoperative site, subcutaneously for postoperative pain management or the continuous infusion of a local anesthetic near a nerve for regional anesthesia. The Patient Control Module allows for intermittent bolus doses of pain medication on patient demand.

Baxter's Multirate Infusor devices with attached PCM, are single-use disposable infusion pumps designed to deliver solution at a constant flow rate of 1-12mL/hr, depending upon the device configuration and settings, as well as allow for intermittent bolus doses of medication on patient demand.

The Medley PCA Module is intended for use in today's growing professional healthcare environment for facilities that utilize infusion devices for the delivery of medications or fluids. The Medley PCA Module is indicated for use on adults, pediatrics, and neonates for continuous or intermittent delivery through clinically acceptable routes of administration; such as intravenous (IV), subcutaneous, or epidural. The addition of the PCA/Monitoring Protocol provides an optional and hospitalconfigurable feature that is intended to align with healthcare facilities' current protocols that require monitoring of patients while on PCA therapy. All device programming, data entry and validation of PCA/Monitoring Protocol parameters is performed by the trained healthcare professional according to hospital-defined protocol or a physician's order. The Medley PCA Module with PCA/Monitoring Protocol is intended for use with patients that are prescribed PCA pain management therapy with opioid medications, specifically: Fentanyl, Demerol, Morphine, and Hydromorphone. The Medley PCA Module with PCA/Monitoring Protocol is intended for use by healthcare professionals in clinical environments. The Protocol does not replace clinician assessment or therapy decision making, but adds an additional safety net for the clinician at the point of care. All device programming, data entry and validation of the Medley PCA Module with PCA/Monitoring Protocol is performed by the trained healthcare professional according to hospital-defined protocol or a physician's order.

Due to the potential for opioid-induced respiratory depression, hospitals require regular monitoring and assessment of patients prescribed opioid medications. By allowing for the combination of a PCA Module and monitoring module (EtCO2 Module and/or SpO2 module) on the same platform, the Medley System provides a readily available way for the clinician to continuously monitor the patient's respiratory response while receiving opioid infusion therapy. This submission will utilize the current system modularity to add a new hospitalconfigured Guardrails parameter (PCA/ Monitoring Protocol) to the Medley PCA Module. This Protocol is designed to help ensure patient safety when administering opioid medications. This Protocol will be available for use when a PCA Module and monitoring module(s) are attached to the same Medley Point of Care Unit (PCU). The PCA/Monitoring Protocol will be part of the Guardrails data set and will consist of a specified list of opioid medications and hospital-specified pre-configured monitoring limits. The Protocol will activate only when hospital-specified protocol indicates an unsafe state of respiratory depression is detected.

The Hospira LifeCare® PCA3 Infusion System is intended for accurate, volumetric, infusion of analgesic drugs by continuous or patient-demanded (PCA) intravenous administration. The LifeCare PCA® Infusion System is also indicated for short-term (less than 96 hours) continuous epidural administration of analgesic drugs.

The Hospira LifeCare® PCA3 Infusion System is a microprocessor controlled, pole mounted, standalone, electromechanical infusion pump that allows a patient to self administer, analgeric usines, a patient pendant, within physician prescribed, programmed parameters. A stepper motor exerts pressure on an inserted drug vial to control the infusion of analgesic into a patient. The infuser is powered from an AC power source and has an internal battery to maintain operation for short periods when an AC power source is not available. The infuser will accept a pre-filled drug vial manufactured by Haspire and includes one sterile empty vial that can be filled by a hospital's pharmacy.

The LifeCare PCA® Infusion System with Hospira MedNet™ Software is indicated for accurate, volumetric, infusion of analgesic drugs by continuous or patient-demanded (PCA) intravenous administration. The LifeCare PCA® Infusion System with Hospira MedNet™ Software is also indicated for short-term (less than 96 hours) continuous administration of analgesic drugs.

The LifeCare PCA® Infusion System with Hospira MedNet™ Software is an electromechanical infusion pump that uses a stepper motor that exerts pressure on an inserted drug vial to control the infusion of analgesic into a patient. The infuser is pole-mounted and includes an attached patient pendant that allows a patient to self-administer analgesia within physician-prescribed, programmed parameters that include delivery mode, PCA dose, lockout interval, and/or dose limits. The LifeCare PCA® Infusion System with MedNet™ Software consists of: - an infuser that is compliant with IEC 60601-1-2 2nd Edition requirements . - a bar code reader that recognizes Hospira- or Abbott-manufactured drug . vials as well as hospital pharmacy-generated bar codes - . a Nurse Call Port - networked communication capability (Ethernet wired and wireless) with . Medication Management compatible hospital information systems - hardware that is compatible with Hospira MedNet™ Software. .