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510(k) Data Aggregation

    K Number
    K142590
    Device Name
    All Safe Huber Safety Infusion Set
    Manufacturer
    NEXUS MEDICAL, LLC
    Date Cleared
    2015-01-16

    (123 days)

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

    NEXUS MEDICAL, LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The All Safe Huber Safety Infusion Sets are used to access surgically implanted vascular ports for the administration of fluids and withdrawal of blood. The All Safe Huber Safety Infusion Sets facilitate the safe removal of the needle and may aid in the prevention of needle stick injuries. The All Safe Huber Safety Infusion Sets are also indicated for power injection of contrast media into the central venous system with implanted vascular ports indicated for power injection. The maximum recommended infusion rate at 11.8 cps is 5 ml/sec for 19 and 20 gauge. Maximum pressure is 325 psi for all gauge sizes.
    Device Description
    Not Found
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    K Number
    K130879
    Device Name
    NEXUS IV TUBING SET WITH LUER-ACCESSBILE ONE-WAY CHECK VALVE - IV PLUS
    Manufacturer
    NEXUS MEDICAL, LLC
    Date Cleared
    2013-07-09

    (102 days)

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

    NEXUS MEDICAL, LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The NIVTS-LACV (Nexus IV Tubing Sets with Luer-Accessible One-Way Check Valve) are intended to administer IV fluids/medication to the patient's vascular system through a needle-free device system that aids in the elimination of needle-stick injury. The Nexus Luer-Accessible One-Way Check Valve (LACV) is designed to allow fluid flow in one direction and stop or check fluid flow in the opposite direction.
    Device Description
    Nexus IV Tubing Sets with Luer-Accessible One-Way Check Valve
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    K Number
    K130416
    Device Name
    NEXUS TKO-6P LUER ACTIVATED DEVICE
    Manufacturer
    NEXUS MEDICAL, LLC
    Date Cleared
    2013-06-12

    (113 days)

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

    NEXUS MEDICAL, LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Nexus TKO®-6P is a pressure-rated, luer-activated, normally closed, bidirectional, neutral pressure anti-reflux device intended for use as an accessory to an IV catheter placed in the vein or artery for intravenous administration of blood, IV drugs and IV fluids to the patient including neonatal, pediatric and immunocompromised patients. The Nexus TKO®6P may also be safely used with power injectors at 10mL/sec and pressures up to 325 psi. The Nexus TKO®-6P incorporates anti-reflux technology which prevents blood reflux resulting from the following conditions: bag run-dry, connection and disconnection of luer lock devices, syringe plunger compression and patient vascular changes, such as coughing or sneezing. The Nexus TKO®-6P has a pre-slit septum which does not require the use of a stainless steel needle and passively aids in the reduction of needlestick injuries.
    Device Description
    Not Found
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    K Number
    K113398
    Device Name
    NEXUS TKO-6, LUER-ACTIVATED DEVICE
    Manufacturer
    NEXUS MEDICAL, LLC
    Date Cleared
    2012-04-18

    (153 days)

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

    NEXUS MEDICAL, LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Nexus TKO®-6 is a luer-activated, normally closed, bi-directional, anti-reflux device intended for use as an accessory to an IV catheter placed in the vein or artery for intravenous administration of blood, IV drugs and IV fluids to the patient including neonatal, pediatric and immunocompromised patients. The Nexus TKO®-6 incorporates anti-reflux technology which prevents blood reflux resulting from the following conditions: bag run-dry, connection and disconnection of luer lock devices, syringe plunger compression and patient vascular changes, such as coughing or sneezing. The Nexus TKO®6 has a pre-slit septum which does not require the use of a stainless steel needle and passively aids in the reduction of needlestick injuries.
    Device Description
    The Nexus TKO®-6 is a luer-activated, normally closed, bi-directional, anti-reflux device intended for use as an accessory to an IV catheter placed in the vein or artery for intravenous administration of blood, IV drugs and IV fluids to the patient including neonatal, pediatric and immunocompromised patients. The Nexus TKO®-6 incorporates anti-reflux technology which prevents blood reflux resulting from the following conditions: bag run-dry, connection and disconnection of luer lock devices, syringe plunger compression and patient vascular changes, such as coughing or sneezing. The Nexus TKO®6 has a pre-slit septum which does not require the use of a stainless steel needle and passively aids in the reduction of needlestick injuries.
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    K Number
    K092382
    Device Name
    NEXUS PRESSURE RATED EXTENSION SETS
    Manufacturer
    NEXUS MEDICAL, LLC
    Date Cleared
    2010-04-26

    (264 days)

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

    NEXUS MEDICAL, LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Nexus Pressure Rated Extension Sets are intended for use in today's growing professional healthcare environment, including healthcare facilities that utilize infusion systems to administer IV fluids, medications, blood and blood products to the patient's vascular system and may be safely used with power injectors at pressures up to 325 psi. The needle-free design allows the user to add medication into the primary line and may also aid in the prevention of needle stick injuries.
    Device Description
    Not Found
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    K Number
    K092930
    Device Name
    NEXUS INTRAVASCULAR TUBING SETS-PRE-PIERCED
    Manufacturer
    NEXUS MEDICAL, LLC
    Date Cleared
    2010-03-10

    (169 days)

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

    NEXUS MEDICAL, LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The NIVTS-P (Nexus IV Tubing Sets – Pre-Pierced) are intended for use to administer IV fluids/medication to the patient's vascular system through a needle.
    Device Description
    Not Found
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    K Number
    K092527
    Device Name
    NEXUS INJECTION SITE, MODEL NIS-8
    Manufacturer
    NEXUS MEDICAL, LLC
    Date Cleared
    2010-02-04

    (170 days)

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

    NEXUS MEDICAL, LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The NIS is a needle-less device intended as an intravascular administration set accessory for the delivery of drugs and fluids. The NIS device may aid in the prevention of needle stick injuries.
    Device Description
    The NIS is a needle-less device intended as an intravascular administration set accessory for the delivery of drugs and fluids.
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    K Number
    K081123
    Device Name
    NEXUS I.V. NEEDLESS ACCESS CANNULA FOR INTRAVASCULAR ADMINISTRATION SETS
    Manufacturer
    NEXUS MEDICAL, LLC
    Date Cleared
    2008-11-14

    (207 days)

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

    NEXUS MEDICAL, LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Nexus I.V. Needless Access Cannula are intended for use to administer IV fluids / medication to the patients vascular system through a needle free system that aids in the prevention of necdle stick injuries.
    Device Description
    Not Found
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    K Number
    K080976
    Device Name
    NEXUS I.V. FLUID TRANSFER DEVICE
    Manufacturer
    NEXUS MEDICAL, LLC
    Date Cleared
    2008-11-10

    (217 days)

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

    NEXUS MEDICAL, LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Nexus I.V. Vial Access Device is intended for use to aid healthcare professionals in mixing and transferring I.V. fluids / medication from a rubber-stopper medication vial to another device, through a needle-free system that aids in the elimination of needle stick injuries.
    Device Description
    Not Found
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    K Number
    K062551
    Device Name
    NEXUS IRRIGATION TUBING SET
    Manufacturer
    NEXUS MEDICAL, LLC
    Date Cleared
    2006-12-15

    (107 days)

    Product Code
    LJH
    Regulation Number
    876.5130
    Why did this record match?
    Applicant Name (Manufacturer) :

    NEXUS MEDICAL, LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Nexus Irrigation Tubing Set is intended for delivery of irrigating solutions from a container to an irrigation site during bladder irrigation, or endoscopic procedures such as cystoscopy, transurethral resection (TUR) and arthroscopic procedures.
    Device Description
    Not Found
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