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510(k) Data Aggregation
K Number
K220288Device Name
NP Medical nPulse K150 Neutral Displacement Needle Free Connector, nPulse Neutral displacement needle free connector, nPulse K150 Needle Free Connector
Manufacturer
Date Cleared
2023-04-19
(442 days)
Product Code
Regulation Number
880.5440Why did this record match?
Applicant Name (Manufacturer) :
NP Medical Inc
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The nPulse™ neutral displacement connector is a single patient use, sterile, nonpyrogenic device for needleless access to the IV line and/or IV catheter during IV therapy. The nPulse™ connector can be used for direct injection, intermittent infusion, continuous infusion, or aspiration.
Device Description
The nPulse K150 Neutral Displacement Needle Free Connector is a single patient use, sterile, non-pyrogenic device for needleless access to the IV line and/or IV catheter during IV therapy. The nPulse K150 Neutral Displacement Needle Free Connector can be used for direct injection, intermittent infusion, continuous infusion, or aspiration. The nPulse K150 valve is a normally closed, luer-activated, valved connector which has an open mode that permits bi-directional fluid flow and a closed mode that prevents fluid flow.
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K Number
K221518Device Name
NP Medical nCompass Extension Set with Stabilizing Base
Manufacturer
Date Cleared
2022-11-03
(162 days)
Product Code
Regulation Number
880.5440Why did this record match?
Applicant Name (Manufacturer) :
NP Medical
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The NP Medical Extension Set with stabilizing base is a sterile single patient use device.
The NP Medical Extension Set is intended for direction, intermittent infusion, continuous infusion or aspiration for all patients for which IV therapy is prescribed.
The NP Medical Extension Set incorporates a normally closed bidirectional pressure-activated valve that prevents low pressure retrograde flow and is intended for power injector procedures to a maximum pressure of 325 psi at a flow rate of 10ml per second.
Device Description
The NP Medical Extension Set with Stabilizing Base is a sterile, single use, nonpyrogenic intravenous administration extension set comprised of a side repositionable tube bonded to a connector hub on one end and a female luer on the other end with a clamp in between. The connector hub has a locking male luer and a rotating tube connection joint. The hub houses a bidirectional Pressure-Activated Valve (PAV) and an integral stabilizer under the connector hub. The stabilizing base component (along with IV tape / adhesive) is intended to help anchor the extension set to the patient. This device is not made with plasticizers Diethylhexylphthalate (DEHP). The NP Medical Extension Set with Stabilizing Base may be used with compatible Vascular Access Devices (VAD), Needle Free Connectors, and other commercially available devices.
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K Number
K203265Device Name
nPro Surgical Mask
Manufacturer
Date Cleared
2021-02-09
(96 days)
Product Code
Regulation Number
878.4040Why did this record match?
Applicant Name (Manufacturer) :
NP Medical Inc
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The nPro surgical masks are intended for operating room personnel health care workers to protect both patients and healthcare workers from the transfer of microorganisms, blood and particulate materials. nPro Surgical Masks are single use, disposable devices provided non-sterile.
Device Description
The nPro surgical mask meets ASTM F2100-19 Level 1 performance requirements for bacterial filtration efficiency, differential pressure, sub-micron particulate filtration efficiency, resistance to penetration by synthetic blood and flame spread.
The three-ply pleated mask fabric can be vertically adjusted to cover the user's mouth and nose. The inner and outer layers are constructed of non-woven fabric. The middle layer is constructed of melt-blown negative charge non-woven fabric and includes a flexible nose wire to the user's nose and reduce air gaps. The three layers of the mask body are collated and ultrasonically welded around the edges to enclose the filter media and nose wire. The polyester-spandex ear loops are ultrasonically welded to the mask body. All materials are not made with natural rubber latex. The nPro Surgical Masks are single use, disposable devices that are provided non-sterile in a dispensing carton.
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K Number
K130023Device Name
K100 NEUTRAL DISPLACEMENT NEEDLE FREE CONNECTOR
Manufacturer
Date Cleared
2013-04-03
(90 days)
Product Code
Regulation Number
880.5440Why did this record match?
Applicant Name (Manufacturer) :
NP MEDICAL, INC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The K100 Neutral Displacement Connector is a single patient use, sterile, non-pyrogenic device for needleless access to the IV line and/or IV catheter during IV therapy. The K100 connector can be used for direct injection, intermittent infusion, continuous infusion, or aspiration.
Device Description
The K100 Neutral Displacement Needleless Connector is a sterile, single patient use, swabable, normally closed, luer-activated, valved connector. The K100 valve is comprised of a: a housing (inlet and outlet), a fluid channel, a translating member (or lower gland) secured to a longitudinal wall of the housing and bounding a variable volume region of the fluid channel, a post having a lumen terminating at a distal head of the post and biased in the proximal direction by the lower gland when in the closed mode, and an upper seal having a sealing ring and secured to the longitudinal wall of the housing, the sealing ring contacting the distal head of the post when in the closed mode to prevent flow through the fluid channel, Moving components within the assembly are lubricated with silicone oil.
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K Number
K973916Device Name
NP MEDICAL CAPLESS LUER ACTIVATED VALVE
Manufacturer
Date Cleared
1998-03-09
(146 days)
Product Code
Regulation Number
880.5440Why did this record match?
Applicant Name (Manufacturer) :
NP MEDICAL, INC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The Capless Luer Activated Valve, incorporating a luer activated valve, is intended for use in facilitating needleless fluid delivery and may be swabbed with antiseptic just prior to use, thereby eliminating the need for capping between uses.
Device Description
The Capless Luer Activated Valve is a two-part device consisting of a Gland Housing Assembly and a Gland/Center Post Assembly, as described below:
The Gland is a valve/gasket which provides a seal against the syringe/luer connector when the device is being utilized. The Gland incorporates a slit to accept the syringe/luer connector. The Gland is also the swabbable surface of the Capless Luer Activated Valve. The valve can be easily swabbed per hospital protocol before each connection.
The Center Post mechanically supports the Gland and serves as the primary high pressure seal to keep the fluid path closed during the resting state.
The Gland and the Center Post are mechanically press-fit together to form the Gland/Center Post Assembly.
In the resting state, the Center Post is flush with the walls of the Gland Housing, ensuring that there is no fluid path. As the device is activated by a syringe/male luer connector, the flexible Gland is forced open and the Center Post is pushed down. As the Center Post is forced further down into the Gland Housing, the fluid path is established.
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