Single-use 3-piece syringe with NRFit Slip connector for regional anaesthesia
Certifications
CE Marked medical device under Council Directive 93/42/EEC on Medical Devices (as amended by Directive 2007/47/EC), according to the B. Braun Declaration of Conformity for Omnifix NRFit (Document No. 094 008).
Class I sterile measuring function (I steril Messfunktion) for Omnifix Slip syringes including article number 4616005, as specified in the Declaration of Conformity 094 008 Omnifix NRfit.
Class IIa classification for Omnifix Lock syringes within the same Omnifix NRFit product family, as listed in the same Declaration of Conformity (contextual family information).
CE Marked medical device under Council Directive 93/42/EEC on Medical Devices (as amended by Directive 2007/47/EC), according to the B. Braun Declaration of Conformity for Omnifix NRFit (Document No. 094 008).
Class I sterile measuring function (I steril Messfunktion) for Omnifix Slip syringes including article number 4616005, as specified in the Declaration of Conformity 094 008 Omnifix NRfit.
Class IIa classification for Omnifix Lock syringes within the same Omnifix NRFit product family, as listed in the same Declaration of Conformity (contextual family information).
Declaration of Conformity issued by B. Braun Melsungen AG, assessed by Notified Body TÜV SÜD Product Service GmbH (Identification number 0123).
Description
Omnifix Syringe 5ml NRFit Slip is a sterile, single-use, 3-piece hypodermic syringe manufactured by B. Braun for regional anaesthesia procedures. It features an NRFit Slip connector in accordance with ISO 80369-6, designed to reduce the risk of misconnections by being dedicated to neuraxial and regional anaesthesia applications. The syringe has a highly transparent polypropylene barrel with clear graduation markings in millilitres, a polypropylene plunger, and a synthetic rubber plunger stopper with a double sealing ring for smooth, controlled aspiration and injection of small volumes. The internal surface is siliconised to optimise plunger movement. The device is latex- and PVC-free and is supplied in a 5 ml nominal capacity configuration. Medisave UK supplies this product as a box of 100 syringes for clinical use in aspiration, injection and infusion of fluids, admixture of drugs, and extraction of body fluids and tissue in regional anaesthesia contexts, when used with appropriate compatible devices.
Bnefits
Single-use, sterile 3-piece syringe designed for regional anaesthesia applications.
NRFit Slip connector in accordance with ISO 80369-6, reducing the risk of misconnections compared with standard Luer connectors.
Highly transparent barrel with black graduation (in ml) for easy reading and accurate dosing of small volumes.
Double-sealed synthetic rubber plunger stopper enables slow and controlled aspiration and injection.
Siliconised internal barrel surface for smooth plunger movement.
Latex- and PVC-free construction to reduce the risk of latex and PVC-related sensitivities.
Suitable for aspiration, injection, admixture of drugs and extraction of body fluids and tissue in regional anaesthesia procedures when used with compatible devices.
Available as a 5 ml syringe in a box of 100 units for efficient clinical use.
Indications
Aspiration and injection of fluids in combination with appropriate medical devices via clinically intended access routes for regional anaesthesia.
Admixture of drugs to an infusion solution, according to the summary of product characteristics (SmPC) of the medication, when used with compatible medical devices.
Declaration of Conformity issued by B. Braun Melsungen AG, assessed by Notified Body TÜV SÜD Product Service GmbH (Identification number 0123).
Designed and labelled as single Use, sterile syringes for regional anaesthesia ("Single Use Syringes, 3 Piece for Regional Anaesthesia") in the Declaration of Conformity.
NRFit connector complying with ISO 80369 6 for neuraxial and regional anaesthesia applications, aiming to reduce the risk of misconnections.
Manufactured in accordance with relevant syringe standards, including ISO 7886 1, as referenced in manufacturer product information for Omnifix syringes.
Latex Free and PVC Free device construction as stated in the B. Braun Omnifix NRFit product description.
Designed and labelled as single Use, sterile syringes for regional anaesthesia ("Single Use Syringes, 3 Piece for Regional Anaesthesia") in the Declaration of Conformity.
NRFit connector complying with ISO 80369 6 for neuraxial and regional anaesthesia applications, aiming to reduce the risk of misconnections.
Manufactured in accordance with relevant syringe standards, including ISO 7886 1, as referenced in manufacturer product information for Omnifix syringes.
Latex Free and PVC Free device construction as stated in the B. Braun Omnifix NRFit product description.
Single-use 3-piece syringe with NRFit Slip connector for regional anaesthesia
Extraction of body fluids and tissue via aspiration together with appropriate medical devices in the context of regional anaesthesia procedures.
Infusion of fluids when used with infusion pumps released as compatible with Omnifix NRFit syringes, in accordance with manufacturer instructions.
Composition
Barrel material: polypropylene (PP) as stated by B. Braun for Omnifix syringes with NRFit connector.
Plunger material: polypropylene (PP).
Plunger stopper: synthetic rubber (specific rubber type not further specified in publicly available product information).
Three-piece construction consisting of barrel, plunger and plunger stopper.
Internal surface of the barrel siliconised to facilitate smooth plunger movement.
Latex-free and PVC-free materials, as specified by the manufacturer for Omnifix NRFit syringes.
Formulation
Device type: sterile, single-use hypodermic 3-piece syringe for regional anaesthesia.
Nominal capacity: 5 ml, with graduation in millilitres on the transparent barrel.
Connector: NRFit Slip connector in accordance with ISO 80369-6 (neuraxial/regional anaesthesia standard).
Three-piece design (barrel, plunger, plunger stopper) with double sealing ring on the stopper for precise control.
Highly transparent barrel with black, wipe-resistant graduation marks for improved readability and dosing accuracy.
Siliconised internal surface for smooth and controlled plunger movement.
Packaging
Commercial presentation: box of 100 syringes as listed by Medisave UK ("Pack of 100").
Each syringe is supplied sterile and intended for single use only.
Specific primary packaging details (e.g., individual blister configuration) are not publicly listed in the available product literature.
Usage
Use only by appropriately trained healthcare professionals in accordance with institutional protocols and regional anaesthesia practice standards.
Intended for aspiration and injection of fluids, admixture of drugs to infusion solutions, extraction of body fluids and tissue, and infusion in regional anaesthesia when used with compatible equipment.
Connect only to NRFit-compatible devices and accessories designed for neuraxial and regional anaesthesia in line with ISO 80369-6; the NRFit connector is not compatible with standard Luer connectors.
Check the sterile packaging before use; do not use if the packaging is damaged or previously opened.
Use immediately after opening the sterile pack and dispose of the syringe safely after a single use; do not re-use or re-sterilise.
Follow the instructions for use of any infusion pump or other device when using Omnifix NRFit syringes in pump-assisted infusion.
Select syringe volume appropriate for the intended dose and procedure (5 ml nominal capacity in this product).
Contraindications
Not publicly listed in the accessible manufacturer and distributor documentation for the Omnifix Syringe 5ml NRFit Slip. Users should follow regional anaesthesia guidelines and the instructions for use provided with the product and associated equipment.
Adverse Effects
Not publicly listed as device-specific adverse effects; any risks are primarily those associated with invasive regional anaesthesia procedures and the medicinal products administered using the syringe, as described in relevant clinical and medicinal product literature.
Storage Conditions
Not publicly listed in detail; generally, sterile single-use syringes are stored in their original packaging, protected from extreme temperatures, moisture and direct sunlight, and kept in accordance with hospital or clinic storage policies and manufacturer recommendations.
Duration
Not publicly listed (device used peri-procedurally according to clinical judgement and procedure requirements).
Onset
Not publicly listed (not applicable to this medical device in the way it is to medicinal products).
