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510(k) Data Aggregation

    K Number
    K142806
    Device Name
    DualCap
    Manufacturer
    CATHETER CONNECTIONS, INC.
    Date Cleared
    2015-05-22

    (235 days)

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

    CATHETER CONNECTIONS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    When left in place for 30 seconds the Light Blue DualCap® disinfects needleless luer access valves and the Dark Blue DualCap® disinfects the IV administration line male luer connections; the caps provide a physical barrier to contamination up to 7 days, under normal conditions if not removed.
    Device Description
    The DualCap® Disinfectant Cap is designed to fit securely on Luer access valves and IV administration line male Luer connections. The cap contains 70% isopropyl alcohol. The Subject device is not made with natural rubber latex, is non-pyrogenic, non-preservative and is not made with DEHP. The product consists of a Light Blue DualCap® for use on Luer access valves and a Dark Blue DualCap® for use on IV administration line male Luer connections. The Light Blue DualCaps® and Dark Blue DualCaps® are available in a number of packaging combinations such as two Light Blue DualCaps®, a Light Blue DualCap® and Dark Blue DualCap® combination, and as singles. Additionally, DualCap® Disinfectant Caps will be marketed for use as an accessory in procedure kits. When being used in procedural kits, the product will be shipped bulk to the kitting manufacturer.
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    K Number
    K142399
    Device Name
    DualCap IV Pole Strips(Disinfectant Caps for Male Luers)
    Manufacturer
    CATHETER CONNECTIONS, INC.
    Date Cleared
    2014-11-19

    (84 days)

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

    CATHETER CONNECTIONS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    When left in place for five (5) minutes, the Dark Blue DualCap disinfects male luer connectors; thereafter the caps provide a physical barrier to contamination up to ninety-six (96) hours under normal conditions if not removed.
    Device Description
    The Dark Blue DualCap" is designed to Internet on all ISO standard mater and man and newides effective disintection of the male luer fromector after five minutes of applicat sterite. This device is not made with natural rubber latex, is non-pyrogenic, preservative free and is not made with DEHP, Additionally Datk Blue DualCap® will be marketed for use as an accessory in procedure kits. When being used in procedural kits, the product will be shipped bulk sterite to the kitting manufacturer for incorporation into the procedure Kits,
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    K Number
    K123967
    Device Name
    CATHETER CONNECTIONS' DARK BLUE DUALCAP FOR MALE LUERS
    Manufacturer
    CATHETER CONNECTIONS, INC.
    Date Cleared
    2013-01-22

    (27 days)

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

    CATHETER CONNECTIONS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    When left in place for five (5) minutes, the dark blue DualCap™ for male luer connectors disinfects the IV administration line male luer connectors; thereafter the caps provide a physical barrier to contamination up to ninety-six (96) hours under normal conditions if not removed.
    Device Description
    The dark blue DualCap™ for male luers is designed to fit securely on IV administration male luer connections. The cap contains 70% isopropyl alcohol. The product is intended for single-use and is provided sterile. This device is not made with natural rubber latex, non-pyrogenic, preservative free and DEHP free.
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    K Number
    K123065
    Device Name
    CATHETER CONNECTIONS DUALCAP SOLO
    Manufacturer
    CATHETER CONNECTIONS, INC.
    Date Cleared
    2012-12-14

    (74 days)

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

    CATHETER CONNECTIONS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    When left in place for five (5) minutes, DualCap Solo™ disinfects needleless luer access valves; thereafter the caps provide a physical barrier to contamination up to ninety-six (96) hours under normal conditions if not removed.
    Device Description
    The DualCap Solo™ is designed to fit securely on luer access valves. The cap contains 70% isopropyl alcohol. The product is intended for single-use and is provided sterile, this device is not made with natural rubber latex, non-pyrogenic, preservative free and DEHP free.
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    K Number
    K113842
    Device Name
    CATHETER CONNECTIONS' DUALCAP SOLO
    Manufacturer
    CATHETER CONNECTIONS, INC.
    Date Cleared
    2012-01-27

    (30 days)

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

    CATHETER CONNECTIONS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    When left in place for five (5) minutes, DualCap Solo™ disinfects needleless luer access valves; thereafter the caps provide a physical barrier to contamination up to ninety-six (96) hours under normal conditions if not removed.
    Device Description
    The DualCap Solo™ is designed to fit securely on luer access valves. The cap contains 70% isopropyl alcohol. The product is intended for single-use and is provided sterile, this device is not made with natural rubber latex, non-pyrogenic, preservative free and DEHP free.
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    K Number
    K112985
    Device Name
    CATHETER CONNECTIONS' DUALCAP DUO
    Manufacturer
    CATHETER CONNECTIONS, INC.
    Date Cleared
    2011-11-09

    (34 days)

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

    CATHETER CONNECTIONS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    When left in place for five (5) minutes, DualCap Duo™ disinfects needleless Luer access valves; thereafter the caps provide a physical barrier to contamination up to ninety-six (96) hours under normal conditions if not removed.
    Device Description
    The DualCap Duo™ is designed to fit securely on Luer access valves. The cap contains 70% isopropyl alcohol. The product is intended for single-use and is provided sterile, latex free, non-pyrogenic, preservative free and DEHP free.
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    K Number
    K093229
    Device Name
    CATHETER CONNECTIONS DUALCAP
    Manufacturer
    CATHETER CONNECTIONS, INC.
    Date Cleared
    2010-04-08

    (176 days)

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

    CATHETER CONNECTIONS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    When left in place for five (5) minutes the female component of DualCap™ disinfects needleless Luer access valves and the male component of DualCap™ disinfects the IV administration line male Luer connections; thereafter the caps provide a physical barrier to contamination up to ninety-six (96) hours under normal conditions if not removed.
    Device Description
    The DualCap™ is designed to fit securely on Luer access valves and IV administration line male Luer connections. The cap contains 70% isopropyl alcohol. The product is intended for single-use and is provided sterile, latex free, non-pyrogenic, preservative free and DEHP free. Additionally DualCap™, the device will be marketed for use as an accessory in procedure kits. When being used in procedural kits, the product will be shipped bulk sterile to the kitting manufacturer (DualCap™ will be packaged in metalized unit container and will be impervious to ETO). The Catheter Connections' DualCap™ will be incorporated into the procedure kit.
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