NeutralSite™ Valve Sterile

m|devices NeutralSite™ valve provides neutral pressure displacement and is specially designed not only to reduce blood reflux to avoid catheter occlusion, but also to decrease the risk of catheter related bloodstream infections (CRBSI) due to its swabable flat surface with pre-slit septum. In addition, the internal straight fluid pathway helps to minimize the priming volume and address dead space concerns.

The NeutralSite™ is recommended for use for up to 7 days as per an independent laboratory test study following the following guidance for Industry and FDA staff: Intravascular Administration Sets Premarket Notification Submissions [510(k)] and Standard: YY/T 0923-2014 needleless access port for fluid lines and blood lines – Test method for microbial ingress.

The NeutralSite™ was challenged with four ATCC test microorganisms, selected in accordance with the FDA guidelines. The NeutralSite™ was challenged with a high concentration of inoculum, which was assessed to be higher than that normally seen in a clinical setting. The mean results produced show that the valve does have an effective barrier with vigorous disinfection, achieving a bacterial log reduction of 7. The study was conducted over a 7-day period with 140 activations.

Features and Benefits

• Flat swabable pre-slit septum.
• Straight internal fluid pathway.
• Low priming volume.
• Neutral pressure displacement with very minimal reflux volume.
• Transparent housing for clear visibility when flushing.
• Gap-less space between the septum and housing mechanically providing an effective microbial barrier against bacterial contamination.
• Compatible with luer lock and luer slip connectors.

Product Data

• Maximum flow rate at 350psi: 10ml/second.
• Number of accesses: over 200 times.
• Priming volume: 0.08ml
• Reflux volume: 0.0059ml
• PSI rating: 350psi
• Lipid resistant.
• ARTG number: 355439
• DEHP NO = Not detected (Result less than the Method Detection Limit EN 14372)
• Not Made with Natural Rubber Latex.
• Recommended use of up to 7 days*
• Material: PP, ABS and silicone.
• Shelf life: 3 years
• MRI compatible: Yes

*This product image is only for reference.