Conforms to ISO 80369 6 neuraxial connector standard (NRFit™) for small Bore connectors.
CE marked medical device with CE Certification number 0050.
Class II piston syringe (general hospital device) with neuraxial connector as per 21 CFR 880.5860 (FDA 510(k) K192538 for BD Syringe NRFit™ Lok and Slip).
Biocompatibility evaluated according to ISO 10993 1 and associated parts (including cytotoxicity, sensitisation, systemic toxicity and pyrogenicity tests).
Performance tested according to ISO 80369 6, ISO 80369 20 and ISO 7886 1/ 2 for leakage, dead space, volumetric accuracy, plunger force and other syringe performance characteristics.
Sterilisation validated for gamma or E Beam irradiation with a sterility assurance level of 10⁻⁶.
Conforms to ISO 80369 6 neuraxial connector standard (NRFit™) for small Bore connectors.
CE marked medical device with CE Certification number 0050.
Class II piston syringe (general hospital device) with neuraxial connector as per 21 CFR 880.5860 (FDA 510(k) K192538 for BD Syringe NRFit™ Lok and Slip).
Biocompatibility evaluated according to ISO 10993 1 and associated parts (including cytotoxicity, sensitisation, systemic toxicity and pyrogenicity tests).
Performance tested according to ISO 80369 6, ISO 80369 20 and ISO 7886 1/ 2 for leakage, dead space, volumetric accuracy, plunger force and other syringe performance characteristics.
Sterilisation validated for gamma or E Beam irradiation with a sterility assurance level of 10⁻⁶.
Neuraxial syringe
Description
Single-use, sterile 10 mL plastic neuraxial syringe with NRFit™ Lok connector from BD, supplied in a shelf box of 200 syringes. The device is designed specifically for neuraxial applications (e.g. spinal, epidural and other regional anaesthesia procedures) and complies with ISO 80369-6 to help reduce the risk of misconnections with non-neuraxial devices. It is a three-piece syringe with a polypropylene barrel, polypropylene plunger rod and elastomeric (polyisoprene) stopper, lubricated with medical-grade silicone. The syringe features a 0.2 mL scale, low dead space (0.10 mL), a yellow neuraxial-specific component for clear identification, and is sterilised by gamma or electron-beam irradiation, with a shelf life of 5 years.
Bnefits
NRFit™ Lok connector compliant with ISO 80369-6, designed to reduce the risk of misconnections to non-neuraxial devices.
Specifically intended for neuraxial use (spinal, epidural and regional anaesthesia) to support safer anaesthetic practice.
10 mL capacity with 0.2 mL graduation scale for accurate aspiration and injection of neuraxial medications or fluids.
Low dead space (approximately 0.10 mL) helps minimise drug waste and improve dosing accuracy.
Three-piece syringe design (barrel, plunger and stopper) with smooth plunger movement for controlled aspiration and injection.
Yellow neuraxial-specific visual cues (plunger/NRFit components) aid quick identification of NRFit syringes in busy clinical areas.
Sterile, single-use construction helps reduce infection risk associated with reuse or cross-contamination.
Supplied in a box of 200 syringes for efficient stock management in theatres, pain clinics and other high-throughput settings.
Manufactured by BD, a globally recognised leader in syringes and medication delivery systems, with extensive biocompatibility and performance testing.
Indications
For neuraxial use by healthcare professionals for aspiration and injection of fluids.
Regional anaesthesia procedures, including spinal and epidural techniques, where neuraxial-specific connectors are required.
Administration of medications intended for neuraxial routes (e.g. intrathecal, epidural) using ISO 80369-6 compatible devices.
Use in operating theatres, anaesthetic departments, pain management services and other clinical environments requiring neuraxial syringes.
Composition
Barrel: Polypropylene, lubricated on the inside surface with medical-grade silicone.
Plunger rod: Polypropylene with yellow colourant to indicate neuraxial-only connection.
Stopper: Elastomeric polyisoprene rubber stopper.
Stopper lubricant: Medical-grade silicone on the outside surface of the stopper.
Tip: NRFit™ Lok connector designed according to ISO 80369-6 neuraxial standard.
Ink/markings: Printed graduated scale in millilitres (mL) on barrel.
Formulation
Three-piece plastic neuraxial syringe (barrel, plunger rod and elastomeric stopper).
10 mL capacity with 0.2 mL graduation scale and low dead space of approximately 0.10 mL.
NRFit™ Lok tip (ISO 80369-6) intended exclusively for neuraxial applications.
Sterile, single-use syringe, supplied ready to use and non-reusable.
Sterilised by gamma or E-beam irradiation with a validated sterility assurance level (SAL) of 10⁻⁶.
Shelf box (inner carton): 200 syringes per box (as marketed: "Box of 200").
Shipping case: 800 syringes per shipping carton (4 shelf boxes of 200).
Outer cartons clearly labelled with BD branding, product description, SKU 400174, GTINs and NRFit/neuraxial identifiers.
Usage
Verify that the packaging is intact and the expiry date has not passed before use; do not use if packaging is damaged or opened.
Remove the sterile syringe from its packaging using aseptic technique.
Attach only to compatible ISO 80369-6 neuraxial devices (e.g. NRFit™ spinal or epidural needles and neuraxial extension sets); do not connect to Luer or other non-neuraxial connectors.
Draw up the prescribed neuraxial medication or fluid by retracting the plunger, using the graduated markings on the barrel to measure the required volume.
Gently expel air bubbles and adjust to the final intended volume using the scale on the barrel.
Connect securely to the neuraxial access device via the NRFit™ Lok connector, ensuring a firm and leak-free connection.
Inject or aspirate slowly and according to the relevant clinical protocol for neuraxial procedures.
Dispose of the syringe safely in an appropriate sharps container immediately after single use; do not recap needles or attempt to reuse or resterilise the syringe.
Contraindications
Do not use for intravenous, arterial, enteral or any non-neuraxial routes; the syringe is intended only for neuraxial applications.
Do not connect to devices with Luer or other non-ISO 80369-6 connectors.
Do not use if the sterile package is damaged, opened or if the product is past its expiry date.
Do not reuse or resterilise; single use only.
Do not use in patients with known hypersensitivity to materials in the fluid path if such hypersensitivity is clinically relevant (e.g. rare silicone or rubber sensitivities).
Adverse Effects
No direct device-specific adverse effects are expected when used correctly; potential risks are related to neuraxial procedures themselves (e.g. infection, bleeding, nerve injury) rather than the syringe as such.
Reuse or improper handling may increase the risk of infection, including meningitis or epidural abscess.
Incorrect connection to non-neuraxial lines or use outside intended neuraxial applications could result in serious medication errors.
Storage Conditions
Store in a clean, dry environment at room temperature, generally between 15°C and 25°C, unless otherwise specified on the packaging.
Protect from excessive heat, direct sunlight and moisture to maintain packaging integrity and sterility.
Keep syringes in their original packaging until point of use to prevent contamination.
Do not freeze or expose to conditions that could damage the plastic components or compromise sterility.
Duration
Not applicable as a medicinal treatment; the syringe is a single-use medical device used transiently during neuraxial procedures. Each syringe is intended to be used once and then discarded.
Onset
Not applicable in pharmacological terms. Functional benefit (secure neuraxial-specific connection and fluid handling) is immediate when the sterile syringe is correctly connected to compatible NRFit\u2122 neuraxial devices.
