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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.

The 20mm SmartSite ™ Vented Vial Access Device is intended for use by healthcare professionals, patients, and/or caregivers in a wide variety of healthcare and home use environments for reconstitution or dispensing of medication. The SmartSite Vented Vial Access Device is indicated for use with standard 20 mm rubber-stopper medication vials for reconstitution or dispensing of medications.

The 20mm SmartSite™ Vented Vial Access Device is a stand-alone, sterile, single-use, disposable device which permits access to a medication vial without the use of a needle. It consists of a vial spike, the vial retention shroud, a hydrophobic filter assembly and a SmartSite™ needle-free valve. The SmartSite™ Vented Vial Access Device is microbiologically closed. When used in a USP<797> compliant pharmaceutical compounding and storage environment, the SmartSite™ Vented Vial Access Device is capable of maintaining the sterility of vial medications for up to 7 days.

Arisure® is a Closed System Drug Transfer Device (CSTD) that mechanically prohibits the release of drugs in vapor, aerosol or liquid form during preparation and administration, and prevents the introduction of microbial and airborne contaminants into the drug or fluid path, allowing the system to minimize exposure of individuals, healthcare personnel, and the environment to hazardous drugs.

Arisure® Closed System Drug Transfer Device (CSTD) uses three primary components to prevent the escape of drug and ingress of microbes: Closed Vial Adapter, Closed Male Luer, and Dry Spike. The Closed Vial Adapter attaches to the drug vial allowing access to the vial contents while preventing vial pressurization by capturing displaced vapor and allowing filtered air into the vial. The Dry Spike attaches to an IV container allowing drug to be injected into the container while a separate port accepts the spike of an administration set. The Closed Male Luer syringe adapter provides a means of closed fluid transfer from the drug vial to the IV container. The Closed Male Luer was designed specifically to access the needle-free valve (neutral valve) on the Closed Vial Adapter and Dry Spike. The fluid path of the Closed Vial Adapter, Dry Spike, and Closed Male Luer is normally closed, opening only when the Closed Male Luer is connected to the neutral valve.

The Arisure™ Closed Vial Adapter is intended for use by healthcare professionals in a wide variety of healthcare environments including hospitals, healthcare facilities, and pharmacies for reconstitution or dispensing of medication. The Arisure™ Closed Vial Adapter is indicated for use with rubber-stopper medication vials for reconstitution or dispensing of medications, including chemotherapy agents.

The Arisure Closed Vial Adapter is intended for use by healthcare professionals in a wide variety of healthcare environments including hospitals, healthcare facilities, and pharmacies for reconstitution or dispensing of medication. The Arisure Closed Vial Adapter is indicated for use with rubber-stopper medication vials for reconstitution or dispensing of medications, including chemotherapy agents. The Arisure Closed Vial Adapter is a mechanically closed device, designed to retain vapors produced from medications in the attached vial.

The Arisure™ Dry Spike allows for the addition of liquid medications to IV containers through a needle-free access port, and serves as a connector between an IV container and a standard IV set, while minimizing exposure to drug aerosols and spills.

The Arisure™ Dry Spike connects between IV containers and standard IV sets for the addition or removal of fluids. A needle-free valve on the side of the device provides a swab-able female access port for connection with ISO standard male luers. The needlefree valve provides an alternative fluid path to the IV container, which is normally accessed via a dedicated lumen within the spike. A pierceable septum distal to the device's spike, incorporates a redundant seal ring to minimize or eliminate fluid leakage that might otherwise occur during the spiking of IV containers. Fluid within the bag is then administered through a second, primary lumen within the spike. A third, vented lumen incorporates a check valve with hydrophobic vent media to equalize vacuum created within rigid containers and glass bottles during the administration of fluids. The Arisure™ Dry Spike was designed to comply with ISO 8536-4:2010 as appropriate. The primary components of the Arisure Dry Spike include a vented lumen, handle, and needle-free valve, which are made of ABS, TPE, and PC/Silicone respectively. All materials were tested in accordance with ISO 10993-1.

The Closed Male Luer (CML) is a single use, sterile, swab-able, bi-directional valve intended for use as an accessory to an Intravascular Administration Set. The Closed Male Luer provides access for the administration of fluids from a container to a patient's vascular system through the administration needle or catheter which is inserted into the vein or artery.

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The SmartSite® Vented Vial Access Device is intended for use by healthcare professionals in a wide variety of healthcare environments including hospitals, healthcare facilities, and pharmacies for reconstitution or dispensing of medication. The SmartSite® Vented Vial Access Device is indicated for use with rubber-stopper medication vials for reconstitution or dispensing of medications, including chemotherapy agents.

The 20mm SmartSite® Vented Vial Access Device is a stand alone, sterile, single-use, disposable device which permits access to a medication vial without the use of a needle. It consists of a spike, locking shroud, hydrophobic filter, and SmartSite® needle-free access valve for Luer access. The SmartSite® Vented Vial Access Device is microbiologically closed. When used in a USP<797> compliant pharmaceutical compounding and storage environment, the SmartSite® Vented Vial Access Device is capable of maintaining the sterility of vial medications for up to7 days.

The SmartSite® VialShield is intended for use by healthcare professionals in a wide variety of healthcare environments including hospitals, healthcare facilities, and pharmacies for reconstitution or dispensing of medication. The SmartSite® VialShield is indicated for use with rubber-stopper medication vials for reconstitution or dispensing of medications, including chemotherapy agents.

The SmartSite® VialShield is intended for use by healthcare professionals in a wide variety of healthcare environments including hospitals, healthcare facilities, and pharmacies for reconstitution or dispensing of medication. The SmartSite® VialShield is indicated for use with rubber-stopper medication vials for reconstitution or dispensing of medications, including chemotherapy agents. The SmartSite® VialShield is a mechanically closed device, designed to retain vapors produced from medications in the attached vial. The SmartSite® VialShield is microbiologically closed. When used in a USP <797> compliant pharmaceutical compounding and storage environment, the VialShield is capable of maintaining the sterility of vial medications for up to 7 days. The subject SmartSite® Vialshield device is constructed of polymeric components: - Upper and Lower Housings: Polycarbonate - Check Valves: Silicone - Lubricant: Silicone - Hydrophobic Filter Membrane: PTFE, Polyester - Loctite 3341: UV adhesive - Barrier Film: Polyether Polyurethane - SmartSite® valve, including: - Body: Acrylic - Cap: Polyurethane - Piston: Silicone - Lubricants: Silicone The subject SmartSite® Vialshield device is provided with a molded polyethylene cap, considered part of the packaging, made using low density polyethylene. The subject SmartSite® Vialshield materials do not contain natural rubber latex.

The Vented Single Vial Access Device is a stand-alone, singleuse, disposable device which permits access to a medication vial without the use of a needle. The device is intended for use by healthcare professionals in a wide variety of healthcare environments, including hospitals, healthcare facilities, and pharmacies. The Vented Single Vial Access Device is indicated for use with standard medication vials and mating luer access devices for withdrawal and/or injection of fluid.

The Vented Single Vial Access Device (ViaLokTM / Universal) is a sterile, stand-alone, single-use, disposable device which permits access to a medication vial without the use of a needle. These devices are inserted into a stopper of a medication vial. The healthcare provider uses the Vented Single Vial Access Device to transfer and mix drugs contained in standard medication vials. The Vented Single Vial Access Device includes three product configurations in this submission: - ViaLok™ 20 mm Single Vial Access Device, Vented, Female Luer . - . ViaLok™ 13 mm Single Vial Access Device, Vented, Female Luer - . Universal Single Vial Access Device, Vented, Female Luer The 20mm and 13mm product configurations are intended to mate with standard medication vial enclosure sizes (20mm and 13mm, respectively). The Universal device does not contain a shroud and can be used independent of enclosure size. Each Vented Single Vial Access Device configuration is offered with a female luer.

The ViaLok™ is a stand-alone, single-use, disposable device which permits access to a medication vial without the use of a needle. The device is intended for use by healthcare professionals in a wide variety of healthcare environments, including hospitals, healthcare facilities, and pharmacies. The ViaLok™ is indicated for use with standard medication vials and mating luer access devices for withdrawal and/or injection of fluid.

The ViaLok™ Non-vented (ViaLok™) is a sterile, stand-alone, single-use, disposable device which permits access to a medication vial without the use of a needle. The ViaLok™ is inserted into a stopper of a medication vial. The healthcare provided uses the ViaLok™ to inject or withdrawal fluid from the vial. The ViaLok™ includes four product configurations in this submission: - ViaLok™ Non-vented, 20mm with female luer . - ViaLok™ Non-vented, 20mm with male luer . - ViaLok™ Non-vented, 13mm with female luer - ViaLok™ Non-vented, 13mm with male luer . The ViaLok™ is offered in two sizes: 20mm and 13mm. The ViaLokTM is configured to mate with standard medication vial enclosure sizes (20mm and 13mm). Each ViaLok™ size configuration is offered in female and male luer versions. The ViaLok™ device is made up of a spike, luer access and a shroud. The spike is used to penetrate a standard medication vial stopper and provide a fluid path. The purpose of the ViaLok™ shroud is to secure the device to a standard medication vial after the stopper is penetrated. The ViaLok™ is molded methyl methacrylate acrylonitrile butadiene styrene copolymer (MABS). The ViaLok™ may be provided with a cap which is molded from a low density polyethylene (female luer) or a high density polyethylene (male luer). The ViaLok™ and protective caps do not contain natural rubber latex.