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510(k) Data Aggregation
K Number
K972527Device Name
PHASEAL, SYSTEM FOR SEALED HANDLING OF CHEMOTHERAPEUTIC AGENTS
Manufacturer
QUALITY SYSTEM CONSULTING
Date Cleared
1997-09-18
(73 days)
Product Code
FPA, LHI
Regulation Number
880.5440Why did this record match?
Applicant Name (Manufacturer) :
QUALITY SYSTEM CONSULTING
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
PhaSeal® closed system for the preparation and administration of parenteral drugs.
PhaSeal Protector 20 - Drug Vial Transfer Adapter: The Protector 20 is fitted to the drug vial and is used as a docking station between the drug vial for the parenteral drug and Injector Luer. In addition the Protector 20 equilibrates the pressure difference which occurs when fluid or air is added or removed from the drug vial. Liquid transfer takes place through tightly fitting elastomeric membranes to minimize exposure to potentially hazardous drug aerosols and spills that can occur during the reconstitution, administration and disposal processes.
PhaSeal Injector Luer - Drug Transfer Needle Device: The Injector Luer has an encapsulated cannula that is permanently locked onto a syringe using a Luer fitting. Sealed transfer of diluent, drug or air, between the single-use syringe and the various components in the system can be made via the Injector Luer in both the preparation and administration phases.
PhaSeal Connector Luer-Lock - Luer Lock Device: The Connector Luer Lock ensures a sealed connection between the single-use syringe and Injector Luer and the patient's IV line. With the help of the Connector Luer Lock, injections can be made without drug spillage.
PhaSeal Infusion Set - Intravascular Administration Set: The Infusion Set is a non-vented infusion device that has a built-in connector to be used as a way of making additions of parenteral drugs to infusion fluids in a closed system. The Infusion Set may be used to administer the infusion fluid.
Device Description
The PhaSeal™ closed system for preparation and administration of parenteral drugs has four component devices that are dedicated to each other to create the system. These single use devices are designed to promote safe handling of medications, particularly cytotoxic drugs. Leakage of drug into the environment is effectively avoided during all three phases of drug handling when the PhaSeal system is used: the preparation of the drug, the administration of the drug to the patient, and waste handling. All drug transferring utilizes a patented double membrane technique. Each element is sealed off with an elastomeric membrane cover. The membranes are joined together and transfer is made via a specially cut injection cannula. When the elements of the system are separated after transfer, the membranes act as tight seals that prevent leakage. PhaSeal utilizes a built-in, patented pressure equalization technique. Air passes from the vial into a special expansion chamber. Neither excess pressure nor vacuum can occur during drug preparation. This effectively prevents aerosol leakage.
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