STOPPER, Luer-lock male/female, sterile, s.u.

STD SINSSTOP2--

Valid Article

Former Code(s): -X SINSZBE0072 SINSZFR0089
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.
A0280 - Syringes - accessories
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.
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)

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STOPPER, Luer lock male/female

Definition

Universal Closing Stopper.

Combi-Stoppers are closing cones with luer lock fitting male and female. They are universally suitable for sterile closing of all open male or female luer lock and luer slip connections and provide a contact-free luer taper.

Synonym

universal obturator, dual end stopper

Specifications

Quality standards

ISO 8536-10, 2015, edition 2, (confirmed 2021) Infusion equipment for medical use - Part 10: Accessories for fluid lines for single use with pressure infusion equipment

Technical specifications

  • Thermoplastic polymer and/or polyethylene
  • Latex free
  • Double stopper:
    • one side: male end: to obturate the female Luer-lock hub of an IV catheter, extension tube, stopcock...
    • other side: female end: to obturate the male cone of a syringe
  • Luer lock connections
  • Sterile, for single use

Packaging & Labelling

Unit sterile packaging in peel-open pack.

Box of 100 pieces

Instructions for use

Please consult the “Manual of nursing Care Procedures, MSF, 2020” available online via the Nursing care working Group sharepoint page.

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MSF requirements

Sterile stopper for secure, leakproof connection to close off all kinds of open IV-accesses in IV-sets or pre-filled syringes (e.g. catheter, syringe, infusion set...)

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