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The Mix2Vial® Transfer Device is intended for transferring drugs contained in two vials.

The subject device, Mix2Vial® Transfer Device (M2V), is a single-use, gamma sterilized, nonpyrogenic device intended for the transfer of drugs contained in two vials. The M2V consists of two vial adapter bodies with piercing spike and wings, connected back-to-back via a Luer connection, with an in-line filter. The female vial adapter (clear) connects to the drug vial and the male vial adapter (blue) connects to the diluent vial. The vacuum present in the lyophilized drug vial draws in the contents of the diluent vial. The female Luer connection interfaces to a syringe and has an in-line 5um filter that strains the drug or solution when aspirated out of the vial. The male connection has a "Tight Grip" that provides a secure connection to the diluent vial having a 20mm neck diameter. Puncturing the elastomeric closure or "stopper" of a drug or diluent vial is achieved by means of an integral polycarbonate cannulated spike located in the center of each Vial Adapter (VA) body of the M2V. Each side of the device (diluent vial side and drug vial side) is a polycarbonate molded part containing a Luer port. After reconstitution, the drug can be administered by disconnecting the diluent vial and connecting a needleless syringe to the female Luer Lock of the female Vial Adapter. The device does not contain any medicinal substances and can be used with drug vials/diluent vials with a neck diameter of 20mm.

The Vial Adapter is indicated for the transfer of drugs contained in a vial.

The Vial Adapter (VA) 20mm is a single-use device that allows for the transfer of drugs contained in a vial. The device is a one-piece polycarbonate molded part with a standard female Luer port for the connection of a syringe. Puncturing the elastomeric closure of a drug vial is achieved by means of an integral plastic cannulated spike located in the center of the Vial Adapter component. The VA 20mm device is supplied with or without an inline filter, based on catalog number. The VA is sterilized utilizing gamma irradiation and is packaged in a Polyethylene Terephthalate Glycol (PETG) blister enclosure. The VA 20mm is packaged in either a Vial First (VF) or a Syringe First (SF) orientation. The device does not contain any medicinal substances or moving parts and is intended for use with standard drug vials having a neck diameter of 20mm.

The Vial2Bag Advanced® 13mm Admixture Device is indicated to serve as a connection between a 50, 100 or 250mL V bag, vial with 13mm closure, and an external IV administration set. The integrated Vial Adapter makes it possible to reconstitute and/or admix drugs prior to administration to the patient. Indicated for adolescent and adult patients only.

The Vial2Bag Advanced® 13mm Admixture Device is a single use, fluid transfer device that allows for reconstitution and transfer of fluids from drug vials into the IV bag containing infusion solution, through the IV bag administration port. The device consists of the body, Protector, IV Port, and an integrated vial adapter. The device is provided as a sterile, nonpyrogenic product. The device is intended to be used with standard drug vials with a seal diameter of 13mm and an elastomeric stopper. The Vial2Bag Advanced® 13mm device is designed to work with a standard 50, 100, or 250mL IV bag and an external IV infusion set. Users should not attach a Vial2Bag Advanced device to another Vial2Bag Advanced Device. The device does not contain any medicinal substances and there are no additional accessories needed or provided with the Vial2Bag Advanced 13mm Device for the device to meet its intended purpose.

The device is intended for the transfer and injection of drugs contained in a vial.

The subject device, MixJect® Transfer Device (MXJ), is a single-use, gamma sterilized, nonpyrogenic device intended for the transfer and injection of drugs contained in a vial. The MXJ device is intended for use by Healthcare Professionals (HCPs) in a clinical, hospital, or other healthcare environment. The subject device is available by prescription use only and has no known contraindications. The MXJ device does not contain any medicinal substances and is only intended for use with drug vials having a neck diameter of 13mm. The subject device has a 3-year shelf life. The MXJ device configuration consists of four main components inclusive of a 30-gauge needle, a vial adapter including integral cannulated spike, MXJ Body, and MXJ Core. The subject device interfaces with a syringe (not supplied) that connects to the female Luer lock port located in the main body of the MXJ device. The MXJ Vial Adapter component connects to a drug vial having a neck diameter of 13mm. The Vial Adapter component contains a piercing spike and a female Luer lock connector. Puncturing of the drug vial stopper membrane is achieved by means of an integral spike located in the center of the MXJ Vial Adapter component. Once the drug vial stopper membrane is breached by the cannulated spike, fluid can travel from the drug vial into the MXJ device main body. A prefilled diluent syringe (not supplied) is then connected to MXJ female Luer lock port. The diluent is injected from the syringe into the drug vial. The reconstituted medicament is then aspirated back into the syringe. The MXJ device is then twisted in a counterclockwise direction, changing the fluid path from the syringe-vial to the syringe-needle. After reconstitution and aspiration, the drug is ready to be administered through the attached MXJ needle. The MXJ primary device package consists of a polyethylene terephthalate glycol (PETG) blister sealed with a Tyvek® lid sealed on top of the blister pack.

Transfer of drugs contained in a vial.

The Vented Vial Adapter HU, is a single use, sterile, non-pyrogenic medical device intended for the transfer of drugs contained in a vial. The device is intended for use in the preparation of drugs for home use, in hospitals, or outpatient nursing units as used/administered by the patient, caregiver, or Healthcare Professionals (HPCs). The subject device is by prescription use only and does not have contraindications. The device does not contain any medicinal substances and there are no additional accessories provided for use with the product. The device has a 3-year shelf life. The Vented Vial Adapter HU allows for the connection of a standard accessory with a female Luer lock to be connected to a vial. The vial adapter body with tight grip hold ("wings") is intended to be attached to a standard drug vial with a neck diameter of 20mm. The device contains a piercing spike, cap with air filter, vent and a female Luer lock connector for attachment to a standard accessory. This dual lumen spike design facilitates rapid withdrawal of the drug/solution without pressurizing the vial by allowing inbound air aspiration through the air filter. The materials of construction of the VVA HU body and cap are polycarbonate, with a 0.2um hydrophobic air filter comprised of 100% expanded PTFE membrane over non-woven polyester membrane support.