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510(k) Data Aggregation

    K Number
    K140657
    Device Name
    CUROS RED PORT PROTECTOR
    Manufacturer
    IVERA MEDICAL, INC.
    Date Cleared
    2014-12-04

    (265 days)

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

    IVERA MEDICAL, INC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Curos Red is intended for use on dialysis catheter female Luers and open female ports on stopcocks as a disinfecting cleaner prior to line connection and to act as a cover between line accesses. In three (3) minutes after application, the Curos Red will disinfect the female Luer and act as a cover until removed. The Ivera Curos Red was tested in vitro against Staphylococcus aureus, Staphylococcus epidermidia coli, Pseudomonas aeruginosa, Candida glabrata, and Candida albicans. The Curos Red in the home or healthcare facility.
    Device Description
    The Curos Red Port Protector contains 70% Isopropyl alcohol and is intended for use on dialysis catheter open female luers and open female ports on stopcocks as a disinfecting cleaner prior to line connection and to act as a cover between line accesses. The Curos Red has a highly visible red color that may allow improved compliance monitoring by easy visual verification to ensure that all open female luers are disinfected and covered. The Curos Red may be used in the home or healthcare facility.
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    K Number
    K121171
    Device Name
    CUROS TIP
    Manufacturer
    IVERA MEDICAL, INC.
    Date Cleared
    2012-11-26

    (223 days)

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

    IVERA MEDICAL, INC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Curos Tips ™ are intended for use as a disinfecting cleaner for male luer connectors. Curos Tips will disinfect the male luer (3) minutes after application and will cover the luer until removed. The effectiveness of the Curos Tips was tested in vitro against Staphylococcus aureus, Staphylococcus epidermidis, Escherichia coli, Pseudomonas aeruginosa, Candida glabrata, and Candida albicans. The Curos Tips may be used in the home or healthcare facility.
    Device Description
    The Curos Tips™ are intended for use on IV administration lines Male luer as a disinfecting cleaner, which contains 70% IPA, prior to line connection and to act as a physical barrier to contamination between line accesses. The Curos Tips have a highly visible green color that may allow improved compliance by easy visual verification. The Curos Tips may be used in the home or healthcare facility.
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    K Number
    K111992
    Device Name
    CUROS PORT PROTECTOR
    Manufacturer
    IVERA MEDICAL, INC.
    Date Cleared
    2012-01-12

    (183 days)

    Product Code
    QBP, LKB, OBP
    Regulation Number
    880.5440
    Why did this record match?
    Applicant Name (Manufacturer) :

    IVERA MEDICAL, INC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Curos is intended for use on swab-able luer access valves as a disinfecting cleaner prior to line access and to act as a physical barrier to contamination between line accesses. Curos ™ will disinfect the valve three (3) minutes after application and act as a physical barrier to contamination for up to seven (7) days (168 hours) if not removed. The effectiveness of Curos Protectors were tested in vitro against Staphylococcus aureus. Staphylococcus epidermidis, Escherichia coli and Pseudomonas aeruginosa, Candida glibrata, Candida albicans and was found to have >4 log reduction. The Curos Port Protector may be used in the home or healthcare facility.
    Device Description
    The Curos™ Port Protector device is a single use, sterile device that contains 70% lsopropyl Alcohol and is intended to be used as a disinfectant for needleless luer activated valves
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    K Number
    K110826
    Device Name
    CUROS PORT PROTECTOR
    Manufacturer
    IVERA MEDICAL
    Date Cleared
    2011-06-23

    (91 days)

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

    IVERA MEDICAL

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Curos™ Port Protector is a device containing 70% Isopropyl alcohol. When left in place for 5 to 15 minutes the Curos™ Port Protector decontaminates the injection port; thereafter the Curos™ Port Protector provides a physical barrier during the intended use.
    Device Description
    The Curos™ Port Protector device is a single use, sterile device that contains 70% Isopropyl Alcohol and is intended to be used as a disinfectant for needleless luer activated valves.
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