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510(k) Data Aggregation
K Number
K120384Device Name
PROTECTOR, INJECTOR, CONNECTOR
Manufacturer
BD MEDICAL-MEDICAL SURGICAL SYSTEMS
Date Cleared
2012-09-12
(218 days)
Product Code
LHI
Regulation Number
880.5440Why did this record match?
Applicant Name (Manufacturer) :
BD MEDICAL-MEDICAL SURGICAL SYSTEMS
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The PhaSeal system is a closed system drug transfer device (CSTD) that mechanically prohibits the transfer of environmental contaminants into the system and the escape of drug or vapor concentrations outside the system, thereby minimizing individual and environmental exposure to drug vapor, aerosols and spills. The PhaSeal Protector also prevents microbial ingress.
Device Description
The PhaSeal® System is a sterile single-use closed system drug transfer device. The closed transfer of liquid takes place through a double membrane technique utilizing self-sealing elastomeric membranes, tightly fitted together through a bayonet fitting on all PhaSeal components. A single lumen cannula perforates the double membranes for the transfer of liquid. When the cannula is retracted the membranes seal off and transfer of environmental contaminants into the system and/or escape of drug or vapor concentrations outside the system, thereby minimizing individual and environmental exposure to drug vapor, aerosols and spills. The PhaSeal® Protector also prevents microbial ingress.
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