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510(k) Data Aggregation

    K Number
    K143583
    Device Name
    Cathivex ¿GV filter units
    Manufacturer
    MERCK MILLIPORE LTD.
    Date Cleared
    2015-08-11

    (236 days)

    Product Code
    FPB
    Regulation Number
    880.5440
    Why did this record match?
    Applicant Name (Manufacturer) :

    MERCK MILLIPORE LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Cathivex®-GV filter units are in-line 0.22um, sterilizing-grade filters for use with intravenously administered aqueous solutions. The filters remove particulates, microbial contamination, and air bubbles in applications where venting and low protein binding membranes are required or desired.
    Device Description
    Cathivex®-GV filter units are sterile, non-pyrogenic, single-use filter devices intended for sterile filtration of aqueous solutions for intravenous infusions. Cathivex®-GV filter units are designed with a Female Luer Lok™ inlet and a Male Luer Lok™ outlet. Cathivex®-GV filter units contain a 0.22um Durapore® hydrophilic filter membrane constructed from polyvinylidene fluoride (PVDF) and a 0.03um hydrophobic vent membrane constructed from polytetrafluoroethylene (PTFE). The filter membrane is designed to remove particles, microorganisms, microprecipitates and undissolved powders which are larger than 0.22 um. The vent membrane is designed to prevent air locks and air emboli by automatically venting air introduced upstream. The filter housing material is molded from PVC.
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    K Number
    K133004
    Device Name
    VENTED MILLEX -GV, CATHIVEX -GV
    Manufacturer
    MERCK MILLIPORE LTD.
    Date Cleared
    2014-03-27

    (183 days)

    Product Code
    BSN
    Regulation Number
    868.5130
    Why did this record match?
    Applicant Name (Manufacturer) :

    MERCK MILLIPORE LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Vented Millex®-GV filter units are syringe filters for sterilization of low volume aqueous solutions for direct patient injection, filtration of laboratory solutions, and filtration of clinical solutions where venting and low protein binding membrane are required or desired. Cathivex®-GV filter units are in-line gravity fed filters for the sterilization of aqueous solutions for administration via the neuraxial route, filtration of laboratory solutions, and filtration of clinical solutions where venting and low protein binding membrane are required or desired.
    Device Description
    Vented Millex®-GV and Cathivex®-GV filter units are sterile, non-pyrogenic, single-use filter devices intended for sterilizing aqueous solutions for medical applications. Vented Millex®-GV is designed with a Female Luer Lok™ inlet and a Male Luer slip outlet, and Cathivex®-GV is designed with a Female Luer Lok™ inlet and a Male Luer Lok™ Both devices contain a 0.22um Durapore® hydrophilic filter membrane outlet. constructed from polyvinylidene fluoride (PVDF) and a 0.03um hydrophobic vent membrane constructed from polytetrafluoroethylene (PTFE). The filter membrane is designed to remove particles, microorganisms, microprecipitates and undissolved powders which are larger than 0.22 um. The vent membrane is designed to prevent air locks by automatically venting air introduced upstream. The filter housing material is molded from PVC.
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