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NASOPHARYNGEAL AIRWAY, Robertazzi type, CH24, sterile, s.u.

https://unicat.msf.org/cat/product/68520
STD SCTDNPAR24-

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.
R010101 - Nasopharyngeal 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 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
P
The order of this product needs to be justified and is only acceptable under certain conditions.
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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NASOPHARYNGEAL AIRWAY, Robertazzi type

Definition

A nasopharyngeal airway (NPA) is a soft, flexible, uncuffed tube placed through the nasal passages so that the distal tip rests in the nasopharynx. It is used to maintain the free passage of air to and from the lungs. The purpose of the flared end is to prevent the device from becoming lost inside the patient's nose.

Synonym

also known as an NPA, nasal trumpet (because of its flared end), or nose hose

Specifications

Quality standards

ISO 5364, 2016, edition 5, (confirmed 2022) Anaesthetic and respiratory equipment - Oropharyngeal airways

Technical specifications

  • Soft flexible material: thermoplastic elastomer (such as neoprene), PVC, silkolatex, latex-free is preferred
  • Rounded, beveled tip
  • Trumpet design
  • 8 sizes: CH20 - CH34
  • Length: adult sizes range from 6 to 9 cm.
    • 6 to 7 cm in the small adult
    • 7 to 8 cm in the medium size adult
    • 8 to 9 cm in the large adult.
  • Sterile, for single use

Packaging & Labelling

  • Unit sterile packaging in peel-open pack
  • box of 10 units

Instructions for use

The correct size NPA is chosen by measuring the device on the patient: the device should reach from the patient's nostril to the earlobe or the angle of the jaw. In addition, choose an NPA which has a diameter a little smaller than the patient's nares. The distal tip of the NPA is properly placed beyond the tongue base but should not be in contact with the epiglottis.

CH = FR

Ext Ø mm

Int Ø mm

Length mm

20

5.0

100 – 115

22

5.5

105 – 125

24

8.1

6.0

105 – 125

26

8.6

6.5

110 – 140

28

9.3 - 9.4

7.0

117 – 155

30

10.0

7.5

118 – 165

32

10.6 - 10.8

8.0

140 – 170

34

11.3

8.5

155 - 170

36

12.0

9.0

170 - 180

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Precautions for Use

Insertion of an NPA is absolutely contraindicated in patients with severe head or facial injuries, or have evidence of a basilar skull fracture due to the possibility of direct intrusion into brain tissue.

MSF requirements

The nasopharyngeal airway has advantages over the oropharyngeal airway (Guedel airway) in certain situations as it can be used in patients with an intact gag reflex, trismus or oral trauma.

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