1. All Products
  2. SINS - Injection supplies
  3. RACHI SET NRFit, Whitacre 25Gx90mm, 5ml Lock syringe + acc1
Public Pricelist

RACHI SET NRFit, Whitacre 25Gx90mm, 5ml Lock syringe + acc1

https://unicat.msf.org/cat/product/80088
STD SINSANPSR1-

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.
A01030101 - Spinal anaesthesia needles and kits
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.
III
In Europe, medical material that fulfills the definition of a medical device according to the MDR (Medical Device Regulation) is classified into 4 classes
CT3+
Thermosensitive codes are defined for storage and transportation temperature requirements of the products.
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/587641/image_1920?unique=1431ed4

This combination does not exist.

Add article to list

   
Create Cancel

Add Kit To Wishlist

   
Create Cancel

RACHI SET NRFit

Definition

A collection of devices intended for the administration of an anaesthetic agent (not included) in the cerebrospinal fluid for the management of pain during surgery. It includes a spinal needle and additional procedural devices (e.g., syringe, wipes). The different injection devices have a NRFit connection to avoid errors of connections with Luer devices. This is a single-use device.

Synonym

spinal set, spinal tray

Specifications

    Image
    Some restricted information has been hidden. Sign in to see this information

    Quality standards

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

    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

    • double tray set
    • co-package of the procedure set with the spinal needle (in its primary package) on top of it.
    • sterile, for single use
      • qty = 1: NEEDLE SPINAL ANAESTH. NRFit, pencil point, 25G x 90mm, with guide: the spinal needle is placed (in its primary package) on top of the procedure pack, inside the co-package. All sets will contain the 25G/90mm needle, in case another needle is necessary it will have to be taken from the stock
      • qty = 1: DRAPE, non-woven, fenestrated 7x12cm, adhesive transparent borders, 75x95 cm, on top of the 2 trays
      • qty = 1: DRAPE, non-woven, 75x90cm, used as outer wrap of the 2 trays + the fenestrated drape, can be used as sterile drape for the table.
      • qty = 3: Applicator sponge, small, in the top tray
      • qty = 2: GALLIPOT, 50 - 100 ml, s.u, for NaCl and disinfectant, one red and one transparent, in the top tray
      • qty = 5: Gauze compresses, 10 cm, 8 ply: in the bottom tray
      • qty = 1: NRFit blunt fill needle, 18G, filter needle: in the bottom tray
      • qty = 1: SYRINGE NRFit-Lock, 5 ml, s.u.: in the bottom tray together with the fill needle

    MSF requirements

    With the introduction of the NRFit connector we will move at the same time to the use of a spinal anesthesia set (without medications = avoid importation / sourcing issues). The set is to be used for each spinal anesthesia, only one set is proposed with a 25G needle (technique of choice). In case another needle is preferred, this needle must be used in combination with the set.

    Some restricted information has been hidden. Sign in to see this information