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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

Clave Neutral-Displacement Connectors (MicroClave™/ NanoClave™/ Clave™Neutron) are intended for the aspiration, injection, or gravity/pump flow of IV fluids and blood upon insertion of a male luer connector. Clave Connectors may be used with power injectors at a maximum pressure of 400 psi and a maximum flow rate of 10ml/sec. Clave Connectors will prevent microbial ingress for seven (7) days.

Clave Neutral-Displacement Connectors are needlefree, bi-directional connectors that utilize a pre-slit septum which prevents microbial ingress when in the un-activated state and allows access to the fluid path when activated with an ISO 80369-7 compliant male luer. The septum offers neutral displacement of fluid during connection or disconnection of a male luer and self-seals upon disconnection to prevent fluid loss or air ingress. The Neutron incorporates additional technology that will prevent fluid displacement resulting from syringe plunger compression; patient vascular pressure changes, such as coughing or sneezing; and IV solution container run-dry. The Clave Family of Connectors do not require a cap but may be used with disinfecting caps containing 70% isopropyl alcohol.

The ProSeal™ CSTD mechanically prohibits environmental contaminants from entering the system and the escape of drug or vapor concentrations from the system, thereby minimizing individual and environmental exposure to drug vapor, aerosols, and spills. The ProSeal™ system also prevents the introduction of microbial contaminations into the drug or fluid path for up to 7 days when used as intended.

The ProSeal™ Bag Spike with Additive Port (or "and Seal Tab" (suffixed ST model no.)) serves as an adaptor between I.V. bags and ProSeal™ CSTD components, facilitating closed system fluid transfer. The spiking port of this device is compatible with generic I.V. spikes. Additionally, the additive port (injection site) allows medication to be added to the bag using the cleared ProSeal™ Injector or Injector Plus (both Syringe Adaptors). The injection site of the ProSeal™ Bag Spike with Additive Port (or "and Seal Tab") and all corresponding interface membranes ensure a dry connection during fluid transfer. Utilizing this component and its appropriate ProSeal™ CSTD connecting component reduces the risk of microbial ingress for up to 168 hours (7 days).

The SteadiSet Infusion Set is indicated for the subcutaneous infusion of insulin administered by an external pump. The infusion set is indicated for single use.

The subject device, Capillary Biomedical, Inc. SteadiSet Infusion Set, is a sterile, non-pyrogenic, intravascular administration set device used to administer insulin from a reservoir cartridge to a patient subcutaneously through a cannula. The infusion set administers insulin by means of a compatible external pump. The infusion set consists of an inserter, tube set, and disconnect cover. The inserter consists of a housing, insertion buttons, an infusion set hub (with cannula) and adhesive patch with protective liner. The inserter facilitates insertion of the cannula subcutaneously. The cannula is a soft medical-grade polymer extruded over a stainless-steel coil. The tube set provides the insulin pathway between the hub's indwelling cannula and an external insulin pump cartridge. The tube set consists of infusion set tubing with a reservoir connector (proximal end) and hub connector (distal end). The disconnect cover can be connected to the hub to provide cover when the infusion set tubing is disconnected from the hub. The device is sterilized by Ethylene Oxide (ETO) and is a single-patient, single-use device.

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.

Qitexio® 4-Way Stopcock is intended to serve as a flow control and delivery device for I.V. fluids injection to the patient's vascular system. The device is indicated for medium pressure injection of fluids. It is also used for delivery of Lipiodol® (Ethiodized Oil) injection. It is intended for single use only. The device is not indicated for use in infusion.

Qitexio® 4-Way Stopcock is intended to serve as a flow control and delivery device for I.V. fluids injection to the patient's vascular system. Qitexio® 4-Way Stopcock is not intended to facilitate bi-directional flows, thus is not designed to be used in infusion. Qitexio® 4-Way Stopcock is designated for single use only (disposable) and is MR safe. Qitexio® 4-Way Stopcock is robust under medium pressure and is verified to be used for Lipiodol (Ethiodized oil) delivery. Qitexio® 4-Way Stopcock is made of a body with four ports (3 female and one male) and one handle with a L-Shape diverter. The L-shaped diverter opens two neighboring ports at the same time, creating a L-shaped communication channel. The male connector includes a mobile ring assembled on the end of male port, and it enables connection locking over female Luer. A small amount of lubricant is applied on the handle stem before placing it in the Stopcock body. The neighboring female port(s) is connected to the I.V. set to accept the delivered drug or fluid. One female port, that is on the opposite side of the male port, does not directly communicate with the patient (male port). This extra port is designed to enable users to inject multiple I.V. fluids, if needed. The operating mechanism is manual and with a simple twisting handle position to determine direction of the fluids. Qitexio® 4-Way Stopcock has only two ports communicating at a time.

The Arisure® Closed Male Luer with Spike Adapter serves as a connector between an IV container and a standard IV set.

The Arisure Closed Male Luer with Spike Adapter, also referred to as Arisure CML with Spike Adapter or CML with Spike Adapter, is an extension of the predicate device, i.e., Closed Male Luer. The primary components of the CML with Spike Adapter include: a Closed Male Luer, a Male Luer Lock Connector, and an Extended Spike Adapter. The subject device allows for administration set preservation when administering multiple drug therapies to the same patient. It provides a needle-free, drip-free connection between an IV bag or a rigid container and an IV administration set. The CML side provides a luer lock connection to a Bag Spike with Neutral Valve. It also gives the user a drip-free disconnect when needing to use multiple bags or bottles for the infusion. The Spike Adapter side allows for a secure connection to any ISO standard IV spike. An IV administration set can be connected safely and securely to the device through a pierceable septum. The CML with Spike Adapter is designed to comply with ISO 8536-4:2019 as appropriate.

For the administration of fluids from a container into the patient's vascular system through a vascular access device.

The proposed devices consist of Solution Administration Sets. These devices include Basic, Secondary, CONTINU-FLO solution sets, Stand-Alone devices and Chemotherapy devices (see Table 2 for a list of subject device set names per product family). They are single use disposable, non-pyrogenic, sterile devices intended for the administration of fluids from a container into the patient's vascular system.

For the administration of fluids from a container into the patient's vascular system through a vascular access device.

The proposed devices are single use disposable devices intended for the administration of fluids from a container to the patient's vascular system. The extension sets consist of a combination of the following components: PVC or PE lined PVC tubing, a clamp, female Luer with non-vented cap, male Luer with filter vented cap. The accessories consist of an anti-siphon valve, back check valve, and 1.2 µm Filter. The accessories are used in combination with IV sets to administer solutions directly from a container to a patient's vascular system.

The ZeroClear™ Bag Access is a component of the ProSeal™ Closed System drug Transfer Device (CSTD) system. The ProSeal™ CSTD mechanically prohibits environmental contaminants from entering the system and the escape of drug or vapor concentrations from the system, thereby minimizing individual and environmental exposure to drug vapor, aerosols, and spills. The ProSeal™ system also prevents the introduction of microbial contaminations into the drug or fluid path for up to 7 days when used as intended.

The ZeroClear" Bag Access is a part of the ProSeal™ Closed System drug Transfer Device (CSTD), used for injecting and infusing IV fluids and drug solutions from a standard IV bag to a patient. It features a bi-directional Luer lock connector, compatible with ISO 80369-7:2021 male Luer connectors and an ISO 8536-4:2019 compliant IV bag spike, including the applicant's eZSURE™ Empty Fluid Container (cleared K223674) and eZSURE™ Empty Fluid Container with ProSeal™ Injection Site (cleared K241442). This sterile, single-use device used with the appropriate connecting devices, ensures dry connections, minimizes exposure to contaminants and drug vapors, and reduces microbial ingress for up to 7 days. It is intended for use by health care professionals in clinical settings for handling hazardous drugs. The Subject device will be a part of a grouping of currently, twelve (12) cleared component device offerings, to the ProSeal™ CSTD system together with Epic Medical's most recently FDA cleared CSTD devices (K241988).