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OROPHARYNGEAL AIRWAY, s.u., non ster., 60mm, ID 4.0mm, black

https://unicat.msf.org/cat/product/84066
STD SCTDAIRGN060

Valid Article

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).
Article is intended to be used with children (<12 years) ONLY.
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.
R010102 - Guedel airway tubes
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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OROPHARYNGEAL AIRWAY, disposable

Definition

A curved plastic tube inserted through the mouth to facilitate airway patency for gas exchange or suctioning. The device prevents the tongue from obstructing airflow. This rigid tube offers a bite-resistant passage for air from the lips to the posterior pharynx. This is a single-use device.

Synonym

oral airway, OPA, Guedel airway, Mayo cannula

Specifications

Quality standards

  • ISO 5364, 2016, edition 5, (confirmed 2022) Anaesthetic and respiratory equipment - Oropharyngeal airways
  • ISO 18190, 2016, edition 1, Anaesthetic and respiratory equipment - General requirements for airways and related equipment
Image

Technical specifications

  • Design: Guedel
  • Material: plastic, latex-free
  • Parts:
    • curved and flattened distal (or pharyngeal) end
    • oval aperture, same lumen from proximal to distal end
    • Straight and reinforced proximal (or buccal) end​ = bite block
    • proximal flange (collar)
      • indicates the size by number and color code
      • is intended to be external to the teeth or gums
  • Non sterile, for single use

​Different sizes: the size is identified on the flange of the cannula (ISO size = length in cm) and with the standard colour as defined by the ISO.

Code

Use

Size ISO

Length

Internal diameter

Colour

SCTDAIRGN040

Neonate

4

40 +/- 2.5 mm

3 mm

Pink

SCTDAIRGN050

Baby

5

50 +/- 2.5 mm

3.5 mm

Blue

SCTDAIRGN060

Small child

6

60 +/- 2.5 mm

4.0 mm

Black​

SCTDAIRGN070

Child

7

70 +5.0 / -2.5 mm

4.0 mm

White

SCTDAIRGN080

Adolescent

8

80 +/- 5.0 mm

4.5 mm

Green

SCTDAIRGN090

Adult

9

90 +/- 5.0 mm

4.5 mm

Yellow

SCTDAIRGN100

Large adult

10

100 +/- 5.0 mm

5.0 mm

Red

Packaging & Labelling

Quantity per box differs according the manufacturer.

Instructions for use

The proper size is selected by holding the airway against the side of the patient's face and ensuring that it extends from the corner of the mouth to the angle of the jaw. If the airway is improperly sized, it will occlude the airway.

An oral airway is placed by inserting a tongue depressor into the patient's mouth to displace the tongue downward and then passing the airway into the patient's mouth, slipping it over the patient's tongue.

In adults it is inserted into the mouth upside-down, and rotated into the normal position once it is inserted about half way.

Lubricant may be useful if the mouth is excessively dry.

Image
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MSF requirements

Replaces the reusable cannulas as these become rare in the market.

The sterility of the device is not a requirement, but is an option that may be choosen because of availability. In this case the specific NST codes should be used to allow a proper stock management.

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