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SYRINGE, Re-Use Prev., Luer, automat. Retract., 2 ml (SafeR)

https://unicat.msf.org/cat/product/91137
STD SINSSRUPA02

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.
A02010205 - Infusion and irrigation syringes with safety system, single-use
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
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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SYRINGE, Re-Use Prevention, retractable, SafeR

Definition

SafeR® is an automatically Retractable Safety Syringe, it is intended to provide a safe, accurate and reliable method for the injection of fluids and medications.

The syringe, once assembled with its needle (SafeR® Sting), incorporates a passive safety mechanism which retracts and contains the contaminated needle after use aiding in the prevention of possible infections due to needle stick injuries and syringe reuse. Needle retraction is activated by the syringe user with one hand, with one just click.

Specifications

The definition of RUP syringes includes syringes that can measure flexible dosing amounts, have removable needles and a feature that blocks the syringe from being used a second time.

This definition is provided for syringes used in curative services where a broad range of injection procedures are performed and are typically 1.0 – 10.0 ml in size.

SIPs cover AD and RUP syringes that have an additional feature to prevent sharps injury, such as a means to contain the infected sharp after use.

  • SIP = sharp (needle stick) injury prevention
  • RUP = re-use prevention
  • AD = auto-disable
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Quality standards

  • ISO 7886-4, 2018, edition 2, Sterile hypodermic syringes for single use - Part 4: Syringes with re-use prevention feature
  • ISO 23908, 2013, edition 1, Sharps injury protection - Requirements and test methods - Sharps protection features for single-use hypodermic needles, introducers for catheters and needles used for blood sampling

Technical specifications

RUP + SIP syringe type B: the mechanism allows multiple plunger aspirations if reconstitution of the medication or the vaccine is required, or if multiple drugs need to be mixed in the same syringe before being administered to the patient.

  • 3-piece syringe: barrel, plunger, plunger seal
  • central tip, Luer-lock type (but not compatible with other Luer-lock devices)
  • graduation: / 0.1 ml
  • available in sizes: 1ml, 2ml, 3ml, 5ml.
  • sterile device, for single use only

Packaging & Labelling

Unit sterile packaging in peel-open pack

Instructions for use

  • Plan safe handling and disposal before any procedure
  • Use safe and effective needle alternatives when available
  • Immediately dispose of contaminated needles in a sharps container

Storage

Shelf life 3 years.

No special storage or transportation condition. Recommendations to store in room temperature. Store in dry and warm place and not exposed to strong light.

MSF requirements

Allows injections using devices with a sharp injury prevention (SIP) and RUP, important in VHF context.

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