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FACE SHIELD, one-way valve, s.u., PVC

https://unicat.msf.org/cat/product/19052
STD SMSUSHIE1--

Valid Article

Former Code(s): -X
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.
R0301 - Respiratory masks
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
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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CPR FACE SHIELD

Definition

A flexible, form-shaped device that is placed over a patient's mouth to administer "mouth-to-mask" exhaled air from the user to the patient during cardiopulmonary resuscitation (CPR). The device is designed to reduce the risk of cross-contamination; it is also used on manikins by students during CPR training. The device typically consists of the mask with a mouthpiece and a non-rebreathing valve and/or bacteria filter. Also referred to as a pocket face mask, it is typically used by emergency medical services (EMS) or as part of first aid kits. This is a single-use device.

Synonym

pocket CPR shield

Specifications

  • PVC transparent sheet with integrated plastic one-way valve
  • Indication allowing to place the sheet on the right side
  • 100 % latex free
  • Folded in a small pouch (± 3 x 2 x 1 cm), optional with key ring
  • Non sterile, for single use

Instructions for use

STRICTLY SINGLE USE

Place the sheet on the lower part of the patient's face and fit the elastic ear bands around the ears.

Make sure to place the right side on the patient's face.

MSF requirements

One-way valve allowing the rescuer to insufflate the patient while avoiding fluids coming from the patient's mouth to go through the valve.

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