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NEEDLELESS CONNECTOR, split-septum, neutral, sterile, s.u.

https://unicat.msf.org/cat/product/73462
STD SINSNLVCSN1

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.
IIa
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)

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NEEDLELESS CONNECTOR, split-septum, neutral

Definition

A small, sterile, stand-alone, needleless plastic valve intended to mate two related intravenous line devices (e.g., hypodermic syringe and catheter port or tubing from an IV administration set) and hold them in a secured, sealed, locked position, and through which IV access is gained. It is intended to eliminate the use of needles for IV administration of medications.

Specifications

Quality standards

ISO 8536-12, 2021, edition 2, Infusion equipment for medical use - Part 12: Check valves for single use

Technical specifications

Neutral: designed to prevent reflux into catheter or tubing with connection or disconnection (possible small amount, 0.02ml, of reflux may occur)

  • Luer activated
  • Smooth septum surface (no valleys, no crevices)
  • Tight seal between septum and housing
  • Straight fluid path
  • Split septum valve: a prepierced septum that can be of blunt cannula or Luer-lock design
  • Minimal residual volume (< 0.2 ml)
  • Clear housing to visualise flushing
  • Compatible with all peripheral and central catheters, with infusion pump sets and with blood products
  • Plastic polycarbonate, latex free
  • No antimicrobial coating
  • Sterile, for single use

Packaging & Labelling

Unit sterile packaging in peel-open pack

Instructions for use

  • Do not over-tighten a Luer beyond the friction fit as this may damage both the Luer and the connector.
  • Do not hold catheter hub during disconnect as this may cause accidental removal of connector from hub.
  • After blood use, the connector can be flushed clean and does not require change-out.
  • Use routine flushing if connector is not used: 10 ml normal saline / 24 hours in order to maintain catheter patency.
  • Change connector in accordance with facility protocol and CDC guidelines: No more frequently than at 96-hour intervals, but at least every 7 days.

MSF requirements

For use with central venous catheters and PICC lines.

​For use with peripheral IV catheters in specific contexts (such as VHF)

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