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The B. Braun Omnifix Syringe NRFit is intended for neuraxial use for aspiration/injection of fluids used by healthcare professionals in healthcare facilities.

B. Braun Medical Inc. Omnifix Syringe NRFit configurations are sterile, single use syringes with ISO 80369-6 NRFit compliant fittings. They are available in 1mL, 3mL, 10mL, and 20mL lock and slip configurations. The NRFit tips allow for connections of neuraxial specific applications while reducing the likelihood of misconnections to non-neuraxial devices. The syringe assembly consists of a barrel with a printed graduated scale in milliliters (mL), a stopper and a plunger rod. The plunger rod is yellow to designate a device intended to only connect to ISO 80369-6 compatible devices such as spinal or epidural needles. The plunger rod is pulled back to aspirate fluids or depressed to inject or expel fluids.

The Artiglass NRFit tip Glass Syringe is intended for use, in conjunction with an epidural needle, to verify the needle tip placement in the epidural space by the Loss of Resistance technique as explained in standard textbooks. These syringes are not intended for injection or aspiration.

The Artiglass NRFit TM tip Glass Syringes provided not sterile with ISO 80369-6 (NRFit™) compliant fittings. They are available in 5mL and 10mL, lock and slip configurations and 5mL and 10mL lock configurations. The NRFit™ tips allow for connections of neuraxial specific applications while reducing the likelihood of misconnections to non-neuraxial devices. The syringe assembly consists of a borosilicate neutral with a graduated scale in milliliters (mL), a borosilicate neutral glass plunger and a nickel-plated brass tip. The plunger rod is amber colored to designate a device intended to only connect to ISO 80369-6 compatible devices such as spinal or epidural needles.

The NRFit® cap is a sterile, single-use device intended to provide positive closure to prevent fluid loss and contamination in Neuraxial devices CADD Cassettes or Syringes utilizing NRFit® connections. The NRFit® cap is intended to be used for less than 24 hours on any single application.

The NRFit® Caps (abbreviated as "NRFit") are ISO 80369-6 compliant caps designed to prevent fluid loss in Neuraxial devices. The NRFit cap is made from medical grade polypropylene with yellow colorant. The NRFit cap is available with either a male neuraxial lock connection or a female neuraxial lock connection. The NRFit cap is made of materials appropriate for a limited exposure duration, externally communicating, tissue/bone/dentin contacting medical device.

The BD® Syringe NRFit™ Lok and BD® Syringe NRFit™ Slip are intended for neuraxial use by healthcare professionals for aspiration/injection of fluids.

The BD® Syringe NRFit™ Lok and BD® Syringe NRFit™ Slip are sterile, single use syringes with ISO 80369-6 (NRFit™) compliant fittings. They are available in 3mL, 5mL and 10mL, lock and slip configurations and 20mL and 50mL lock configurations. The NRFit™ tips allow for connections of neuraxial specific applications while reducing the likelihood of misconnections to non-neuraxial devices. The syringe assembly consists of a lubricated polypropylene barrel with a graduated scale in milliliters (mL), a lubricated synthetic rubber stopper and a polypropylene plunger rod. The plunger rod is yellow to designate a device intended to only connect to ISO 80369-6 compatible devices such as spinal or epidural needles. The plunger rod is pulled back to aspirate fluids or depressed to inject or expel fluids.

The device is indicated for local administration, and regional administration, specifically, wound infiltrations, peripheral nerve block, and epidural block. The device is not indicated for subarachnoid/spinal blocks.

The proposed device is a disposable neuraxial syringe consist of three components: piston, plunger and barrel; and provided in a variety of volumes: 1ml, 3ml, 6ml, 10ml, 30ml, 35ml, 50ml, 30ml and 60 ml. The barrel of the syringe is printed with graduated markings indicating the volume of liquid inside the barrel. The proposed device is used to inject anesthesia medicine with the cooperation of the spinal anesthesia needles and epidural anesthesia needles which has an NRFit connectors in compliance with ISO 80369-6. The NRFit tip could help to reduce the residual risk of misconnections. The proposed device is provided in two statuses: sterile. The non-sterile NRFit syringe is intended to be sterilized prior to use to repackagers/medical device manufacturers, and the sterile NRFit syringe is supplied to the end user. The sterilized product is sterilized by Ethylene Oxide Gas to achieve a SAL of 10th and supplied sterility maintenance package which could maintain the sterility of the device during the shelf life of five years.