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The TECHNOFLEX DMRX Empty solution container is empty container used for administration of intravenous solutions to the patient using an intravascular administration set. Medication transfer in and out of the container is done using aseptic technique. After use the bag is discarded.

The subject device DMRX Empty Solution Container are IV bags for hospital use which consist of two tubes necessary for the filling of the bag itself and the administration of the solution to the patient. a) fill port to fill the container/injection port for additions of other medications and; b) a spike port to connect an intravascular administration set to the bag to dispense medication. One port is an injection port, which will be used for filling the bag with the solution. The filling will be made with a needle, using aseptic technics by a laboratory personnel or pharmacist. The elastomeric plug is auto sealable and does not require a cap after filling. The administration will be performed by nurses or personnel appropriately trained. They will connect an administration set to the second port which is a twist-off port (spike port). The device is an empty flexible container (bag) made of PP (Polypropylene), SEBS (Styrene Butadiene Copolymer), Thermoplastic Elastomer, PC (Polycarbonate), and Polyisoprene with silicone. One port is an injection port. The empty bag is filled by connecting a needle into the injection port. Using aseptic technics by a trained laboratory personnel or pharmacist, the filling is done by the tube with the injection port connector. After filling, the bag remains closed due to the self-sealing plug which secures the contents prior to administration. To make the fluid outflow from the bag towards the patient, the bag is connected to an intravascular administration set via the second port (spike port). When the bag is already filled, other medications can be added using the injection port. The device will be available in four containment volumes (100mL, 250mL, 500mL, and 1000mL). Bags are double packed and proposed sterilized with e beam radiation.

The Empty Fluid Container is used to hold an admixture of compatible fluids for intravenous administration to a patient. Medication transfer in and out of the container is done using aseptic technique.

The eZSURE™ Empty Fluid Container (EFC) devices are empty single-use, sterile, nonpyrogenic flexible IV container devices/ bags. These are discarded after use. The Subject EFC is made of non-PVC materials. The Nexcel Film for IV bag of the Subject EFC device is composed of a flexible plastic film bag and the device is provided in a two-port configuration with closures. A closed system inlet-/ entry-/ additive- port is used for filling one or more compatible fluid(s) into the bag by a transfer set/ syringe without needle with the ProSeal™ Injector or ProSeal™ Injector Plus (cleared K240171) attached, and another port, the spiking/ administration port, is used for accessing the infusate in the bag with a standard bag spike in an IV therapy administration from the EFC. The transfer device with a male Luer lock attached with the ProSeal™ Injector (or ProSeal™ Injector Plus) is used to connect to the filling-/ additive- port for filling. The additive port incorporates a ProSeal™ Injection Site (cleared K240433) as its integrated subcomponent; hence no other injection needle/ cannula is needed. The transfer device is removed at the end of the preparation step, and the self-sealing additive-/ injection-/ filling- port secures the admixture contents until their administration.

The Empty Fluid Container is used to hold an admixture of compatible fluids for intravenous administration to a patient. Medication transfer in and out of the container is done using aseptic technique.

The eZSURE™ Empty Fluid Container (EFC) devices are empty single-use, sterile, nonpyrogenic flexible IV container devices/ bags. These are discarded after use. The Subject EFC device is composed of a flexible plastic film bag and two separate ports with closures, one for injection and another, infusion. An inlet-/ entry-/ additive- port is used for filling one or more compatible fluid(s) into the bag by a transfer set/ syringe without needle, and another port, the spiking/ administration port, is used for accessing the infusate in the bag with a standard bag spike. A transfer device with a male luer lock is used to connect to the filling-/ additive- port for filling. The additive port incorporates a needle-free valve; hence no injection needle/ cannula is needed. The transfer device is removed at the end of the preparation step, and the needle-free self-sealing additive-/ injection-/ filling- port secures the admixture contents until their administration. For administration to a patient, the device is then connected to an external IV set /IV line, via a bag spike. The IV bag is piped by inserting the spike point of a bag spike into the spiking-/administration- port of the IV bag, doing this by performing a twisting motion. When the bag is already filled, other medications can be added using the additive/ injection/ filling port, even during administration. Medication transfer in and out of the container is done using aseptic technique. The bags range in volume capacity of 100 mL, and 500 mL. The device has a hanger hole so it can be placed on an IV bag holder. The EFC is made of non-PVC materials and provided in a two-port configuration: The needle free additive port which is used for filling the container and the other, the spiking -/ administration port, which is used for IV therapy administration from the EFC. The EFC sub-components are externally communicating devices with no contact to the blood path. The contact duration is categorized as B-prolonged, (>24h to 30d), per ISO 10993-1 :2018 biocompatibility guidelines.

The Disposable Infusion Bag for Parenteral Nutrition is for use in compounding and storage of parenteral nutrition solutions prior to and during administration to a patient using an intravascular administration set. The device is not intended to store the fluids for 24 hours or greater.

The proposed device is for use in compounding and storage of parenteral nutrition solutions prior to and during administration to a patient using an intravascular administration set. The proposed device is provided sterile and single use. The proposed device is available in 7 series due to different bag capacities, different tube locations and different tube materials.

The Empty EVA Bag is an empty container used for administration of solutions to the patients using an intravascular administration set. Medication transfer in and out of the container is done using aseptic technique.

The product is an empty flexible container (bag) in plastic material, that is to be filled before use, intended for the administration of intravenous infusion solutions), and provided sterile. It is provided in two different configurations, with three tubes or one tube: - bag with 3 tubes: The empty bag is filled by connecting it to containers (generally glass bottles) filled with the solutions to be administered. The filling is done through the tube with the big bore connector where the non- re-opening clamp is located; this tube is closed with a screwed cap (air-tight closure). After filling, the bag is clamped by means of the non-re-opening clamp and closed with the sealing cap (screwed cap), to secure the contents prior to administration. To make the fluid outflow from the bag towards the patient, the bag is connected to an intravascular administration set via the access port (spike port). When the bag is filled, other drugs can be added using the second access port (injection port). The device is available in multiple containment volumes ranging from 250mL to 5000mL. - bag with 1 tube: the bag is provided with one tube used both for the filling of the bag and the administration of the solution to the patient. The tube is closed with a screwed male Luer cap (air-tight closure). The filling is done by connecting the female Luer connector of the tube to the containers filled with the solutions to be administered. After filling, the bag is clamped by means of a pinch clamp and closed with the sealing cap (screwed cap), to secure the contents prior to administration. To make the fluid outflow from the bag towards the patient, the bag is connected to an intravascular administration line via the same female Luer connector. It is available in multiple containment volumes of 50mL, 100mL, and 250mL.

The SmartSite™ Bag is an empty container used for administration of intravenous solutions to the patient using an intravascular administration set. Medication transfer in and out of the container is done using aseptic technique.

The SmartSite™ Bag is a single-use, empty IV container, which will be available in 100mL, 250mL, and 500mL product sizes. The SmartSite™ Bag is labeled as sterile fluid path, and contains both an add port and a spike port. The add port facilitates aseptic transfer of medication(s) into or out of the bag. The spike port contains a twist-off protective seal. Either the add port or the spike port can be connected to an intravenous (IV) administration set for medication delivery to the patient. The add port may be repeatedly accessed in accordance with the Directions for Use (DFU). The SmartSite™ Bag may be used for up to 24 hours after the initial access of the add port, consistent with prescribing information for the medications used.

The Empty EVA Bag is an empty container used for administration of TPN (Total Parenteral Nutrition) solutions to the patient using an intravascular administration set. Medication transfer in and out of the container is done using aseptic technique.

The device is an empty flexible container (bag) in EVA material (Ethylene-vinyl acetate), that is to be filled up before use and intended for the administration of intravenous infusion solutions (TPN-Total Parenteral Nutrition). The bag is provided with three tubes necessary for the filling of the bag itself and the administration of the solution to the patient. The empty bag is filled by connecting it to containers (generally glass bottles) containing one or more solutions. The filling is done by the tube with the big bore connector where the non-re-opening clamp is located. After filling, the bag is clamped by means of non-re-opening clamp ad closed with the sealing cap (screwed cap), to secure the contents prior to administration. To make the fluid outflow from the bag towards the patient, the bag is connected to an intravascular administration set via the access port (spike port). When the bag is already filled, other medications can be added using the second access port (injection port). The device will be available in multiple containment volumes ranging from 250mL to 5000mL.

An empty container with sterile fluid path used to hold an admixture of compatible fluids for administration to a patient. Medication transfer is done using aseptic technique.

The subject device is an empty two-port style EVA container available in sizes ranging from 50 mL to 4000 mL. The devices are provided sterile and packaged in multi-pack kits. The intended use is to hold an admixture of compatible fluids for administration to the patient. Medication transfer is done using aseptic technique.

The Additive Port Cap is indicated for use on the medication port of Baxter VIAFLEX, Baxter AVIVA, and Baxter ALL-IN-ONE EVA containers to provide both visual evidence that medication has been added and tamper evidence once the device is closed.

The Additive Port Cap (APC) is a polypropylene, single use device designed to snap over the outside of the medication port of compatible Baxter IV container (Baxter VIAFLEX, Baxter INTRAVIA, Baxter AVIVA, and Baxter ALL-IN-ONE EVA) after the addition of medication. Once closed, the device prevents the port from being accessed without causing visible damage to the IV container. The bright red coloration serves as a clear indicator that medication has been added. The APC device is non-fluid path and non-sterile. The APC device is marketed as a stand-alone device and packaged in bulk.

The Empty EVA Bag is an empty container used for administration of intravenous solutions to the patient using an intravascular administration set. Medication transfer in and out of the container is done using aseptic technique.

The Empty EVA Bag is an empty container used for administration of intravenous solutions to the patient using an intravascular administration set. Medication transfer in and out of the container is done using aseptic technique. The empty bags are filled by connecting them to containers - generally glass bottles closed by a pierceable membrane - containing one or more solutions through standard spikes and tubing. After filling, the transfer set is removed and the bags are clamped by means of inviolable clamps to secure the contents prior to their administration. To make the fluid outflow from the bag towards the patient, the container can be then attached to an intravascular administration set via the spike port and twist - off connector. When the bag is already filled, other medications can be added using the injection port. The bags range in volume capacity from 150 ml to 5000 ml. The device is sold sterile and cannot be re-used or re-sterilized; it is discarded after use. The Empty EVA Bag is intended for use by qualified staff.