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510(k) Data Aggregation
K Number
K112073Device Name
INFUSITE NEEDLELESS ACCES DEVICE (STERILE, BULK NON-STERILE) AND INFUSITE NEEDLELESS ACCESS DEVICE 'Y' ADAPTER (BULK...
Manufacturer
Date Cleared
2012-04-11
(266 days)
Regulation Number
880.5440Why did this record match?
Applicant Name (Manufacturer) :
RX DEVICES LLC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The InfuSite Needleless Access Device is a closed system needleless accessory, which permits blood sampling, intermittent injection or infusion of fluids or medications when connected exclusively to luer systems.
Device Description
The InfuSite Needleless Access Device is a closed system needleless multi-purpose catheter accessory, permitting blood sampling, intermittent injection or continuous infusion of fluids or medications. Connection is exclusively with the Luer systems. The InfuSite Needleless Access Device has a polycarbonate male/female luer housing with a swabable silicone membrane, which opens automatically upon connection with a male luer and closes automatically when the male luer is disconnected. Disinfection must be carried out before and after use. The InfuSite contains no metallic components.
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