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Found 15 results
510(k) Data Aggregation
K Number
K142590Device Name
All Safe Huber Safety Infusion Set
Manufacturer
NEXUS MEDICAL, LLC
Date Cleared
2015-01-16
(123 days)
Product Code
FPA
Regulation Number
880.5440Why 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
K130879Device 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
880.5440Why 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
K130416Device Name
NEXUS TKO-6P LUER ACTIVATED DEVICE
Manufacturer
NEXUS MEDICAL, LLC
Date Cleared
2013-06-12
(113 days)
Product Code
FPA
Regulation Number
880.5440Why 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
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K Number
K113398Device Name
NEXUS TKO-6, LUER-ACTIVATED DEVICE
Manufacturer
NEXUS MEDICAL, LLC
Date Cleared
2012-04-18
(153 days)
Product Code
FPA
Regulation Number
880.5440Why 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
K092382Device Name
NEXUS PRESSURE RATED EXTENSION SETS
Manufacturer
NEXUS MEDICAL, LLC
Date Cleared
2010-04-26
(264 days)
Product Code
FPA
Regulation Number
880.5440Why 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
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K Number
K092930Device Name
NEXUS INTRAVASCULAR TUBING SETS-PRE-PIERCED
Manufacturer
NEXUS MEDICAL, LLC
Date Cleared
2010-03-10
(169 days)
Product Code
FPA
Regulation Number
880.5440Why 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
K092527Device Name
NEXUS INJECTION SITE, MODEL NIS-8
Manufacturer
NEXUS MEDICAL, LLC
Date Cleared
2010-02-04
(170 days)
Product Code
FPA
Regulation Number
880.5440Why 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
K081123Device 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
880.5440Why 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
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K Number
K080976Device Name
NEXUS I.V. FLUID TRANSFER DEVICE
Manufacturer
NEXUS MEDICAL, LLC
Date Cleared
2008-11-10
(217 days)
Product Code
LHI
Regulation Number
880.5440Why 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
K062551Device Name
NEXUS IRRIGATION TUBING SET
Manufacturer
NEXUS MEDICAL, LLC
Date Cleared
2006-12-15
(107 days)
Product Code
LJH
Regulation Number
876.5130Why 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
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