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510(k) Data Aggregation
K Number
K162826Device Name
Encore Neutral
Manufacturer
Date Cleared
2017-06-15
(251 days)
Product Code
Regulation Number
880.5440Why did this record match?
Applicant Name (Manufacturer) :
RyMed Technologies, LLC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The Encore™ Neutral is intended for single patient use in intravenous and blood administrations and aspiration without the need for needles, thus eliminating the potential for needle-stick injuries during use.
The Encore™ Neutral may be used with low pressure power injectors having a maximum pressure of 325 psi and a maximum flow rate of 10 mL/sec. The subject device does not have to be changed subsequent to use with a low pressure power injector.
Device Description
The Encore™ Neutral is a luer activated needleless IV Connector that is disposable and for single patient use. It includes the following features:
- . smooth swabbable surface
- . tight seal integrity with no gaps or openings
- straight-through fluid pathway resulting in zero dead space ●
- 100% effective blood clearing
- neutral fluid displacement ●
- . low priming volume
- saline-only flush option
- . no clamping sequence or positive pressure syringe technique required
The Encore™ Neutral is a sterile single-use device which is provided individually packaged. The Encore™ Neutral is also provided bulk non-sterile, to be further processed (packaged and sterilized) by another manufacturer.
The Encore™ Neutral is available with an optional protective end cap attached to the male luer of the device.
The Encore™ Neutral is compatible with ISO 594 compliant male luer slip devices and male luer lock devices.
The Encore™ Neutral is composed of medical grade materials that are not made with Bisphenol A (BPA), di-2-ethylhexyl phthalate, diethylhexyl phthalate (DEHP) or natural rubber latex. The materials used have been subjected to and have passed biocompatibility testing per the latest ISO 10993 standards.
The Encore™ Neutral is MR Safe as it does not contain metallic, magnetic or metal components.
The Encore™ Neutral may be used with low pressure power injectors having a maximum pressure of 325 psi and a maximum flow rate of 10 mL/sec. The device does not have to be changed subsequent to use with a low pressure power injector. When used with a low pressure power injector, the Encore™ Neutral must be secured with other devices rated for pressures up to 325 psi with a luer lock connection.
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