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510(k) Data Aggregation
K Number
K171117Device Name
Carefusion NeutraClear Needle-free connector (EL-NC1000)
Manufacturer
Date Cleared
2017-09-01
(140 days)
Product Code
Regulation Number
880.5440Why did this record match?
Applicant Name (Manufacturer) :
Cair L.G.L
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
Carefusion NeutraClear™ Needle-free connector is a bidirectional valve allowing injections and infusions to be given or sample taken via an intravenous line; or samples taken via arterial line. It seals and protects the line when it is not activated. The Carefusion NeutraClear™ needle-free connector may be used with low-pressure power injectors procedures to a maximum pressure of 325psi with a flow at 10mL per second.
Device Description
Carefusion NeutraClear™ Needle-free connector is a sterile, non-pyrogenic bidirectional needleless injection valve intended for single patient use as an accessory to intravascular administration sets allowing infusions to be given or samples taken via an intravenous line or via arterial line without using a needle, thus eliminating the potential for needle-stick injuries during use. It seals and protects the line when it is not activated. This bidirectional needleless injection valve may be used with low-pressure power injectors to a maximum pressure of 325psi with a flow at 10mL per second. The Carefusion NeutraClear™ can be used for up to 200 activations or 7 days.
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K Number
K171118Device Name
Carefusion NeutraClear multi-fuse Extension Set with needle-free connector(s)
Manufacturer
Date Cleared
2017-08-15
(123 days)
Product Code
Regulation Number
880.5440Why did this record match?
Applicant Name (Manufacturer) :
Cair L.G.L
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
Non- pressure rated: The Carefusion NeutraClear™ multi-fuse Extension Set with needle-free connector(s) is for single use only. The extension set can be used for direction, intermittent infusion, continuous infusion, or aspiration.
Pressure rated: The Carefusion NeutraClear™ multi-fuse Extension Set with needle-free connector(s) is for single use only. The extension set can be used for direct infusion, continuous infusion, or aspiration. This set may be used with power injector procedures to a maximum pressure of 325psi at a flow rate of 10mL/s.
Device Description
Carefusion NeutraClear™ multi-fuse Extension Set with needle-free connector(s) are Extension Sets that are intended for single patient use, including pediatrics and immunocompromised patients, for direct injection, intermittent infusion, continuous infusion or aspiration of drugs, blood or fluids. All Carefusion NeutraClear™ multi-fuse Extension Set with needle-free connector(s) has a Neutraclear connector that is removable or bonded to the extension set tubing. Carefusion NeutraClear™ multi-fuse Extension Set with needle-free connector(s) allows thorough and easy disinfection due to a solid flat smooth surface and eliminates the risk of needle stick injuries. Carefusion NeutraClear™ multi-fuse Extension Set with needle-free connector(s) are sterile single patient devices that can be used for 200 activations and for 7 days. All extension set included are not made from natural rubber latex or DEHP.
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