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The BD Intelliport™ System is an automated record keeping system that incorporates patient safety features that are aligned with hospital patient records and protocols. The system is comprised of an injection port and software that enables the identification, measurement, alerting and documentation of the administration of medications to patients. The BD Intelliport™ System allows the clinician to record anesthesia-related medication administration events during pre-procedure, intra-procedure and recovery phase. The system is indicated for use by healthcare professionals in a hospital or medical center setting with patients who are receiving manually administered bolus intravenous injections as part of their care to facilitate documentation of the medications. The BD Intelliport™ System is intended for patients with body weights >20 kg. Do not use the BD Intelliport™ System with blood, blood products, biologics, or chemotherapeutics.

BD Intelliport™ System integrates into an intravenous line and automatically captures information about the anesthesia medications administered to the patient. It wirelessly transmits anesthesia medication administration information to the patient's Electronic Medical Record (EMR) via hospital server applications (Gateway software). The BD Intelliport™ System provides core technologies that enable key functions of the system: • Medication Identification: Informs clinician of medication and concentration along with any informational notifications such as patient allergy and expired medication reminders. This occurs when syringes with the correct type of RFID encoded label are attached. • Dose Measurement: Measures volume of drug administered to the patient through the system, then calculates dose weight. • Automatic Charting: Wirelessly transmits measured doses to the EMR. The following are the main system components: • BD Intelliport™ Injection Site which is comprised of the following two components: - BD Intelliport™ Sensor - BD Intelliport™ Reader • BD Intelliport™ Mount (optional accessory) • BD Intelliport™ 2-Bay Charger (accessory) • BD Intelliport™ Gateway

The Iradimed Corporation's MRidium 3870 MRI Infusion Pump System is indicated for general hospital or clinical use by medical professionals whenever it is required to infuse patients with intravenous fluids where a large magnetic field could be present such as Magnetic Resonance Imaging (MRI). The MRidium 3870 MRI Infusion pump can also be used during transport within the clinical environment as part of the periprocedural care before or after the MRI exam. The MRidium 3870 MRI Infusion Pump can be used with up to a 3.0 Tesla MRI system when placed as close as clinically possible to the MR system, without being placed within the magnet's bore, up to a 15,000 Gauss magnetic field line. The pump and infusion sets are designed to deliver saline and IV medication. The system is useful in the administration of fluids requiring precisely controlled infusion rates. The system can operate in primary, loading, bolus, or KVO delivery mode. The dedicated Iradimed 1056, 1058, and 1059 Infusion Sets for the MRidium 3870 MRI Infusion Pump are intended for single patient use up to 6 hours. The device is intended for Adult and Pediatric patients, including Neonates. Careful clinical considerations involving drug and dosing should always be applied especially with regard to neonatal subpopulations (i.e., low and extremely low birth weight). This device is available for sale only upon the order of a physician or other related licensed medical professional, and not intended for any home use applications.

The MRidium 3870 MRI Infusion Pump System is indicated for general hospital or clinical use by medical professionals whenever it is required to infuse patients with intravenous fluids where a large magnetic field could be present such as Magnetic Resonance Imaging (MRI). The MRidium 3870 MRI Infusion Pump can also be used during transport within the clinical environment as part of the periprocedural care before or after the MRI exam. The MRidium 3870 MRI Infusion Pump can be used with up to a 3.0 Tesla MRI system allowing placement as close as physically possible to the MRI scanner without being placed within the magnet's bore, up to a 15,000 Gauss magnetic field line. The magnetic content of the Pump is such that there is no hazard of magnetic attraction, up to 3T (30,000 gauss). The pump unit is designed with an integral single peristaltic pump channel utilizing an ultrasonic (non-magnetic) motor. The integral infusion set mounting channel is horizontally oriented in the front of the pump with position detection sensors and graphical user feedback to aid the user in the correct infusion set loading process. The main assembly of the pump unit contains the controls, display, power supply, battery, and processor/memory functions suitable to meet all system requirements. A remote display (3875) is also available as an option for independent viewing and control from the adjacent MRI Control Room area (Zone III). The Dose Rate Calculator feature allows the user to set up a patient's infusion rate based upon user selected parameters, including volume to be infused, dose, concentration, weight, and/or time. The Dose Rate Calculator feature also provides a Drug Library, allowing the user to program a patient's infusion protocol from selected parameters, including volume to be infused, dose, concentration, weight and/or time with soft and hard limits for each drug. These Drug Library inputs can only be created or modified by the Iradimed in-house clinical team based on input and validation from the healthcare facility. Once programmed, the library is digitally signed requiring proper verification by a software 'key' within the 3870 MR IV pump upon loading. Loading of the drug library requires access to the Password protected Service Menu. The Dose Error Reduction System (DERS) feature allows user-facilities to provide input to custom names, and doses, with hard and soft limits for use in the Drug Library. The Drug Library supports care area specific infusion protocols for primary, bolus, loading dose, and KVO delivery modes, retrievable by drug/protocol name. The library, as prescribed by the healthcare facility, is programmed with nominal starting values for: Dose, Concentration, and Time. Also, hard limits (maximum and minimum allowable) and soft limits (high and low limits that require a user confirmation to exceed) for Dose, Concentration, Time and Patient Weight can be programmed.

The BD Alaris Infusion System with Guardrails Suite MX is a modular infusion pump and monitoring system for the continuous or intermittent administration of fluids to adult, pediatric, and neonatal patients through clinically accepted routes of administration: intravenous (IV), intra-arterial (IA), subcutaneous, epidural, or irrigation of fluid spaces. See Pediatric*, Neonate**, and Adult Patient Population Tables 2 and 3 for the module-specific variations. Administered fluids include pharmaceutical drugs, red blood cells, and other blood components (platelets and fresh frozen plasma) as required for patient therapy. The BD Alaris Infusion System with Guardrails Suite MX is an interoperable system capable of communicating and exchanging data with compatible information technology systems. The BD Alaris Infusion System with Guardrails Suite MX includes the PC Unit (PCU) and one or more of the following: Pump Module, Syringe Module, end-tidal CO2 (EtCO2) Module, Auto-ID Module, Patient-Controlled Analgesia (PCA) Module, and associated software applications. EtCO2 Module is a capnograph that continuously monitors end-tidal carbon dioxide (EtCO2), fractional inspired carbon dioxide (FiCO2), and respiratory rate (RR). BD Alaris Pump Module and Syringe Module and the Alaris PCA Module are indicated for varying patient populations, routes of administration, and infusates.

The BD Alaris Infusion System with Guardrails Suite MX is a modular infusion and monitoring system designed to provide controlled delivery of drugs and fluids, and to provide monitoring of respiratory parameters. The BD Alaris Infusion System with Guardrails Suite MX has three (3) major components: 1. **System Hardware:** A core hardware unit with user interface (BD Alaris PC Unit or PCU) and attachable modules each with a distinct function. * BD Alaris Pump Module (LVP) * BD Alaris Syringe Module (SYR) * Alaris PCA Module (PCA) * BD Alaris EtCO2 Module (EtCO2) * Alaris Auto-ID Module (Auto-ID) 2. **Guardrails Suite MX Software:** Software applications for support and interaction with the system hardware * BD Guardrails Editor (GRE) * BD Alaris Systems Manager (SM) * BD Alaris Systems Maintenance (ASM) 3. **Interoperability Software:** Software applications for facilitating bi-directional communication between the PCU and attached LVP and SYR modules, and an electronic medical records (EMR) system via BD Alaris Infusion Systems Manager (SM) and Care Coordination Engine (CCE), a non-medical device Medical Device Data System (MDDS). * Calculation Services * Infusion Adapter (IA) The PCU is the core of the BD Alaris Infusion System with Guardrails Suite MX and necessary for its operation. It provides a common user interface for programming, and powering and monitoring attached modules. Modules must be physically connected to the PCU to operate. The connection is made by direct attachment to a PCU or through attachment to a module that is attached to a PCU. The attachment is made using inter-unit interface (IUI) connectors built into both sides of the PCU and modules, which also serve to provide power to the modules and communication between the PCU and attached modules. The PCU is powered by AC power and has a rechargeable battery to allow for continued therapy during power interruptions. The attachable modules are dedicated to controlled delivery of fluids, pharmaceutical drugs, parenteral nutrition, and blood and blood products into patients, patient-controlled administration of analgesics, monitoring of end-tidal carbon dioxide, and scanning identifications of patient, physician, and infusates into the system. - **The BD Alaris Pump Module (LVP)** delivers fluids accurately over programmed times and can detect and notify the user of situations that could impact patient safety, such as improper set loading, occlusion, and air-in-line. It can deliver fluids continuously or intermittently from any compatible container using a dedicated BD Alaris infusion set. Flow rates range from 0.1 to 999 mL/h and bolus doses can be programmed at the start or during continuous infusion. - **BD Alaris Syringe Module (SYR)** is designed for injecting fluids from compatible syringes and can detect and notify the user of situations that could impact patient safety, such as an improperly loaded syringe and occlusion. It can deliver continuous or intermittent volumes from 1 to 50 mL syringes at flow rates of 0.01 to 999 mL/hr. - **The Alaris PCA Module (PCA)** is designed for patient-controlled analgesia. It shares core components and functionality with the BD Alaris Syringe Module but includes additional features such as: a dose request cord for self-administering pain medication, software with a dose lockout interval, and a locking syringe enclosure door with a key. When configured for use with the BD Alaris EtCO2 Module, it can also trigger a pause of the PCA infusion if the respiratory rate of a patient falls outside the limits. - **The BD Alaris EtCO2 Module (EtCO2)** a capnograph used for continuous, non-invasive monitoring of end-tidal CO2, fractional inspired CO2, and respiratory rate. It can be used to monitor respiratory depression in patients when using the Alaris PCA Module. - **The Alaris Auto-ID Module (Auto-ID)** features an internal barcode image scanner and an optional handheld scanner. Scanning a clinician ID unlocks the PCU panel in authorized user mode and links clinical event logs with the clinician. Scanning a patient ID band associates logs with the patient, while scanning IV fluid or medication barcodes selects the specific item from the drug library for infusion modules. The PCU and attachable modules have multiple processors running embedded software. The embedded software provides various functions, such as: bootloader, user interface, networking, sensor monitoring, motor control, data processing, power control, keypad processing, and communication. The PCU with its attached modules is designed to be configured to communicate and interact with the Guardrails Suite MX software applications including software for interoperability with Electronic Medical Record (EMR) systems. Communication between the PCU and the software applications is accomplished through either a direct serial connection or through a wireless connection utilize the respective Guardrails Suite MX Software applications. - **The BD Guardrails Editor (GRE)** allows for the creation of drug and fluid libraries and guidelines, called 'profiles,' for specific patient populations. GRE also provides a transfer tool to transfer a profile to PCU via serial cable. - **The BD Alaris Systems Manager (SM)** manages connectivity and includes a web application, communications server, and database software for managing data, creating reports, connecting with a healthcare facility's network, and storing system configuration, user permissions, and historical data. Use of SM also supports transferring wireless software updates to the PCU during system servicing. - **BD Alaris Systems Maintenance (ASM)** is used for standard maintenance tasks, including module calibration and network configurations - **The BD Alaris Interoperable software** includes the Infusion Adapter (IA) and Calculation Services to support bi-directional communication between the BD Alaris Infusion System with Guardrails Suite MX and the healthcare facility's EMR. The Infusion Adapter facilitates data exchange ensuring correct message formats and content. Calculation Services performs pre-defined rule-based calculations to obtain infusion duration, body surface area (BSA), and weight-based dose. It is important to note that interoperability does not include remote control of the BD Alaris Infusion System with Guardrails Suite MX. The PCU and attached modules cannot be programmed remotely. Only infusion parameters can be prepopulated on the pump using interoperability and these parameters must be manually confirmed by the clinician at the bedside before they are activated.

The Plum Solo™ Precision IV Pump is intended for administration of parenteral fluids, medications, and whole blood and blood products through the following routes of administration: intravenous, intra-arterial, and subcutaneous. The Plum Solo™ Precision IV Pump is intended for use in clinical environments in the hospital and other outpatient healthcare facilities by licensed healthcare professionals. These healthcare professionals are trained in the use of the infusion pump and the administration of therapies consistent with the intended use. The Plum Solo™ Precision IV Pump is intended for adults, pediatric (including infants and children), and neonatal patient populations.

The Plum Solo™ Precision IV Pump is a large volume pump (LVP) with one pump channel that can deliver fluid to a patient from 1 to 2 lines independently. The Plum Solo™ Precision IV Pump can only be used with dedicated PlumSet™ administration sets (not subject of this filing). The pump channel accepts a cassette that is part of a PlumSet™ administration set and can connect to a primary and/or secondary container. The fluid is delivered from the upstream lines either serially (piggyback) or concurrently through the cassette to the downstream line. The flow rate accuracy precision has been improved (lower allowed variance) by implementing the new motor mechanism, as well as increased precision for programming concentration, flow rate and VTBI entries. The overall delivery accuracy of the system has improved to +/- 3% per TIR 101 standard condition testing and +/-5% for non-standard conditions.

The Plum Duo™ Precision IV Pump is intended for administration of parenteral fluids, medications, and whole blood and blood products through the following routes of administration: intravenous, intra-arterial, and subcutaneous. The Plum Duo™ Precision IV Pump is intended for use in clinical environments in the hospital and other outpatient healthcare facilities by licensed healthcare professionals. These healthcare professionals are trained in the use of the infusion pump and the administration of therapies consistent with the intended use. The Plum Duo™ Precision IV Pump is intended for adults, pediatric (including infants and children), and neonatal patient populations.

The Plum Duo™ Precision IV Pump is a large volume pump (LVP) with two independent pump channels that can deliver fluid to a patient from 1 to 4 lines independently. In addition, although the channels can operate independently, patient parameters can be shared across the channels to aid in ease of programming. The Plum Duo™ Precision IV Pump can only be used with dedicated PlumSet™ administration sets (not subject of this filing). Each pump channel accepts a cassette that is part of a PlumSet™ administration set and can connect to a primary and/or secondary container. The fluid is delivered from the upstream lines either serially (piggyback) or concurrently through the cassette to the downstream line. Each pump channel cassette has an independent downstream line (patient line), so the clinician can connect each downstream line to a single infusion site or two separate infusion sites. The flow rate accuracy precision has been improved (lower allowed variance) by implementing the new motor mechanism, as well as increased precision for programming concentration, flow rate and VTBI entries. The overall delivery accuracy of the system has improved to +/- 3% per TIR 101 standard condition testing and +/-5% for non-standard conditions.

The LifeShield™ Infusion Safety Software Suite is a collection of software products that facilitates networked communication between compatible systems. The Infusion Safety Software Suite provides trained healthcare professionals the ability to manage data for compatible infusion pumps. All data entry and validation of infusion parameters on compatible infusion pumps is performed by a trained healthcare professional. LifeShield™ Infusion Safety Software Suite is indicated for use in patients including adult, pediatric and neonate undergoing infusion therapy with connected compatible infusion pumps (as per the indications for use specified for the compatible infusion pump). The LifeShield™ Drug Library Management (DLM) software product is intended to be used by pharmacists to create, configure, edit, and manage drug library data, including infusion pump settings, for use with compatible infusion pumps. Drug library contents are constructed based on the healthcare provider's defined best practices. The LifeShield™ Clinical Dashboards & Reports (CDR) software product provides trained healthcare professionals with the capability to view and manage infusion information collected from compatible infusion pumps. Healthcare professionals may choose to use the collected infusion information to support continuous quality improvement programs, or to analyze and trend various aspects of the infusion pumps and therapies used. It is not intended to be a substitute for good clinical management practices, nor does its operation create decisions or treatment pathways. The LifeShield™ Data Flow Management (DFM) software product is intended to facilitate bi-directional communication with compatible infusion pumps, information technology systems, and other LifeShield™ Infusion Safety Software Suite products. LifeShield™ DFM provides a way to automate the programming of infusion parameters, thereby decreasing the number of manual steps necessary to enter infusion data. LifeShield™ DFM forwards infusion-related information received from the infusion pump to compatible information technology systems.

The LifeShield™ Infusion Safety Software Suite is a cloud-based platform provided as a software-as-a-service (SaaS) designed to be compatible with the Plum Duo™ Precision IV infusion pump and Plum Solo™ Precision IV infusion pump. The LifeShield Infusion Safety Software Suite is hosted by Amazon Web Services (AWS) as its cloud provider. LifeShield™ Infusion Safety Software Suite consists of a collection of software services which, when used together, provide a comprehensive set of data management capabilities for trained healthcare professionals when working with infusion pumps. LifeShield™ Infusion Safety Software Suite does not remotely control or program the infusion pump or provide the ability to remotely manage pump alarms such as real-time monitoring, clearing and silencing alarms. The LifeShield™ Drug Library Management (DLM) software is used by pharmacists to create approved drug libraries that can be downloaded by the infusion pumps. The latest software version introduces enhancements to its user interface and additional drug library settings for support of Plum Duo™ and Plum Solo™ pumps. The LifeShield™ Clinical Dashboards & Reports (CDR) software is used by clinical administrators to view infusion or device-related information received from the infusion pumps via the LifeShield™ DFM. The information presented by the software does not create decisions or treatment pathways for patients. The latest version of the software improves the data presented for ongoing infusions and dashboards. LifeShield™ Data Flow Management (DFM) software facilitates bidirectional communications between the infusion pump and hospital information systems (HIS); it routes pharmacy-validated orders to the connected pumps and infusion-related information to the HIS. The latest software version adds the ability to forward alarms to the HIS.

The RemunityPRO™ Pump for Remodulin® (treprostinil) Injection (the RemunityPRO System) is intended for continuous subcutaneous delivery of Remodulin (treprostinil) Injection for use in patients, ages 17 and older.

The RemunityPRO™ Pump for Remodulin® (treprostinil) Injection is a wearable infusion pump designed to deliver Remodulin® (treprostinil) subcutaneously for the treatment of pulmonary arterial hypertension (PAH). Remodulin® was FDA-approved under NDA 021272. The system consists of several components: a wearable pump assembly, a remote interface, and accessories (e.g., rechargeable batteries, battery charger, charging cable, power adapter). A commercially available subcutaneous infusion set is connected to the pump assembly via a standard luer connector for the delivery of Remodulin® from the system to the patient. The RemunityPRO™ Pump for Remodulin® (treprostinil) Injection is prescription use only. The pump assembly is composed of a durable pump and a disposable, single-use cassette with a userfilled drug reservoir. The pump infuses Remodulin® subcutaneously into the patient based on an individualized programmed rate. Each disposable cassette may be used for up to 72 hours after attachment to the pump. The subject system utilizes a micro-dosing pump mechanism supplemented with acoustic volume sensor feedback to ensure delivery accuracy. The subject device has updated branding and also modifies the predicate device to be used with an additional infusion set.

The VIA360™ Surgical System is indicated for delivery of controlled amounts of viscoelastic fluid during ophthalmic surgery. It is also indicated to cut trabecular meshwork tissue during trabeculotomy procedures.

The VIA360™ Surgical System is a manually operated surgical instrument used by ophthalmologists to deliver controlled amounts of ophthalmic viscoelastic fluid into the anterior segment of the eye. The VIA360™ Surgical System is comprised of a surgical-grade stainless steel cannula and a nylon microcatheter. The cannula is attached to a nose piece that can be rotated to a desired position for use in either eye. The microcatheter is advanced and retracted up to 40 mm per cycle by rotating the scroll wheel. The microcatheter has patterned markings every 10 mm to help measure the extended length. A controlled amount of viscoelastic fluid is dispensed through multiple outlets located on the microcatheter's distal tip by depressing the scroll wheel or the surrounding button. An external reservoir is included for the purpose of priming the device. The device is single-use only.

The Remunity® 2.0 Pump for Remodulin® (treprostinil) Injection (the Remunity 2.0 System) is intended for continuous subcutaneous delivery of Remodulin (treprostinil) Injection for use in patients, ages 17 and older.

The Remunity 2.0 System is a wearable infusion pump designed to deliver Remodulin® (treprostinil) subcutaneously for the treatment of pulmonary arterial hypertension (PAH). Remodulin® was FDA-approved under NDA 021272. The system consists of several components: a wearable pump assembly, a remote interface, and accessories (e.g., rechargeable batteries, battery charger, charging cable, power adapter). A commercially available subcutaneous infusion set is connected to the pump assembly via a standard luer connector for the delivery of Remodulin® from the system to the patient. The Remunity 2.0 System is prescription use only. The pump assembly is composed of a durable pump and a disposable, single-use cassette with a user-filled drug reservoir. The pump infuses Remodulin® subcutaneously into the patient based on an individualized programmed rate. Each disposable cassette may be used for up to 72 hours after attachment to the pump. The subject system utilizes a micro-dosing pump mechanism supplemented with acoustic volume sensor feedback to ensure delivery accuracy.

The Belmont Rapid Infuser RI-2 is designed to be used in general or alternative care environments to provide warmed blood and fluids to any patients ≥ 10 kg requiring warmed infusion from 2.5 mL/min to 1000 mL/min. - Infusion of crystalloid, colloid, or blood product, including packed red blood cells, as volume replacement for patients suffering from blood loss due to trauma or surgery. - Infusion of warmed fluid to rewarm patients after surgery or for hypothermia. - Infusion of warmed fluid for irrigation in urology procedures. The 3.0L reservoir is an optional accessory for use in adults only.

The Belmont® Rapid Infuser, RI-2 combines advanced microprocessor technology with an efficient mechanical system to provide a high speed, simple and safe system for rapid infusion of warmed fluids. The Rapid Infuses blood, replacement IV fluids or irrigation fluids warmed to physiologic temperature at user-set rates from 10 to 1000 milliliters per minute (mL/min). Low infusion rates of 2.5 mL/min (150 mL/hr) and 5.0 mL/min (300 mL/hr) are also available to keep the venous line open. The system monitors temperature, line pressure, and air in the fluid path to ensure safe operation and alarms at all unsafe conditions. A hardware override circuit prevents unsafe operation in case of system computer failure. A touch screen displays flow rate, total fluid infused, temperature of the infusate, line pressure, alarm and status messages and proper procedures to proceed safely after an alarm situation. A battery backup allows for mobile transport of the patient and system. During battery operation, fluid warming is disabled while pump operation limited to 50mL/min and safety monitoring remain active.