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Plastic NRFit™ Lok Syringe 10 mL Box of 200

Plastic NRFit™ Lok Syringe 10 mL Box of 200

Becton Dickinson

Medical disposables
  • 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.

Packaging

  • Primary packaging: Individually sterile-packed syringes (unit dose packaging).
  • 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.

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