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FILL NEEDLE NRFit, 18G, blunt, 5 µm filter, sterile, s.u.

https://unicat.msf.org/cat/product/80096
STD SINSTRNR01-

Valid Article

The product is supplied (and stored) sterile, it must remain sterile until its use. Sterile = state of being free from all living microorganisms.
Single use
A single-use device, also referred to as a disposable device, is intended for use on one patient during a single procedure. It is not intended to be reprocessed (i.e., cleaned and disinfected or sterilized).
CE marking: declaration that the product meets EU standards for health, safety, and environmental protection. The CE marking indicates that the product may be sold freely in any part of the European Economic Area, regardless of its country of origin.
A019001 - Blunt needles
European Medical Device Nomenclature (EMDN) is the nomenclature of use by manufacturers when registering their medical devices in the EUDAMED database. EMDN is characterised by its alphanumeric structure that is established in a seven-level hierarchical tree.
I sterile
In Europe, medical material that fulfills the definition of a medical device according to the MDR (Medical Device Regulation) is classified into 4 classes
OC subscriptions: included in supply or field order tools (e.g. UniField)
SC subscriptions: included in supply or field tools
OC validations: approved for procurement and use by an OC for international or local orders specifying context and activity in Medical Standard Lists (MSL)
https://unicat.msf.org/web/image/product.template/587640/image_1920?unique=1431ed4

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FILL NEEDLE, NRFit

Definition

A sterile, slender, rigid, blunt metallic tube intended to be attached to a NRFit syringe and used to aspirate and transfer fluid medication from a vial/ampule.

It includes an integral filter (e.g., a microporous stainless-steel filter) intended to retain micro-particles from the drug as it flows through the needle to reduce the risk of particle contamination of the patient medication.

Synonym

neuraxial filter needle

Specifications

Image

Quality standards

  • ISO 80369-1, 2018, edition 2, Small-bore connectors for liquids and gases in healthcare applications - Part 1: General requirements
  • ISO 80369-6, 2016, edition 1, Small bore connectors for liquids and gases in healthcare applications Part 6: Connectors for neuraxial applications

Quality Standards Comment

ISO 80369-6:2016 specifies requirements for small-bore connectors intended to be used for connections in neuraxial applications. Neuraxial applications involve the use of medical devices intended to administer medications to neuraxial sites, wound infiltration anaesthesia delivery, and other regional anaesthesia procedures or to monitor or remove cerebro-spinal fluid for therapeutic or diagnostic purposes.

NOTE 1 Sites for the neuraxial application include the spine, intrathecal or subarachnoid space, ventricles of the brain, and the epi-, extra-, or peri-dural space. Neuraxial application anaesthetics can be administered regionally affecting a large part of the body, such as a limb, and include plexus blocks, such as the branchial plexus blocks or single nerve blocks. Neuraxial application procedures include continuous infusion of wounds with local anaesthetic agents.

Technical specifications

  • Length : 4 – 5 cm
  • Diameter : 18 – 19 G
  • Integrated 5 µm filter
  • Blunt point
  • With locking cap
  • NRFit connection
  • Sterile, for single use

MSF requirements

Included in the rachi set

The blunt point diminishes the risk of needle accidents but is sharp enough to perforate the rubber stopper of medication vials.

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