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510(k) Data Aggregation
(245 days)
The BD PhaSeal™ Optima system is an airtight and leakproof closed system drug transfer device (CSTD) that mechanically prohibits the transfer of environmental contaminants into the system and the escape of drug vapor concentrations outside the system, thereby minimizing individual and environmental exposure to drug vapor, aerosols and spills. The BD PhaSeal™ Optima system also prevents microbial ingress for up to 168 hours.
BD PhaSeal™ Optima Closed System Transfer Devices (CSTD) are sterile, single use closed system drug transfer devices intended for the reconstitution and transfer of antineoplastic or other hazardous drugs in the healthcare setting. The BD PhaSeal™ Optima system is comprised of four devices—Protector, Injector, Connector, and Infusion Adapter.
The closed transfer of liquid drugs takes place through a double membrane utilizing self-sealing elastomeric membranes that are tightly fitted together through the collet-style fitting on each of the BD PhaSeal™ Optima system devices. During use, the single lumen cannula of the Injector perforates the double membranes for the transfer of liquids. When the cannula is retracted, the membranes seal to prevent the transfer of environmental contaminants into the system and/or escape of drug or vapor concentrations outside the system, thereby minimizing the individual and environmental exposure to drug vapor, aerosols, leaks and spills. The BD PhaSeal™ Optima system prevents microbial ingress for up to 168 hours. Performance of the self-sealing membrane has been substantiated for up to 10 penetrations.
The BD PhaSeal™ Optima Connecting Set (C83-O) is a sterile, single patient use sterile device that enables the administration of non-hazardous and hazardous parenteral drugs when used with the devices that have the compatible mating component - the BD PhaSeal™ Optima Spike Set and/or Connector. The BD PhaSeal™ Optima Connecting Set will be utilized by healthcare workers who administer parenteral hazardous drugs.
The BD PhaSeal™ Optima Spike Set (C180-O) is a sterile, single patient use sterile bag access device that enables the preparation and administration of non-hazardous and hazardous parenteral drugs when used with devices that have the compatible mating component - the BD PhaSeal™ Optima Injector and/or Connecting Set. The BD PhaSeal™ Optima Spike Set will be utilized by healthcare workers who prepare and administer parenteral hazardous drugs.
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