Intended purpose of use: for maintenance of a clear airway through the buccal cavity and the pharynx by preventing blockage by the tongue.
Product description:
Oropharyngeal airway/Cannula, Guedel type, Colour coded as per size
Size: Length 50 mm±2.5 mm, ISO size 5, Inner diameter 3.5 mm minimum, Colour code: Blue, paediatric (Baby)
Material: Medical grade plastic such as Polyethylene vinyl acetate (EVA) / Polyvinyl chloride (PVC)
phthalate free
Semi-rigid, clear and transparent.
Surface shall be marked with the size and manufacturer name.
Parts:
curved and flattened distal (of pharyngeal) end with oval aperture
Straight and reinforced proximal (of buccal) end​ to function as bite block
proximal flange (collar) intended to be external to the teeth of gums.
Atraumatic tip.
Smoothly rounded edges.
sterile, Single use only.
The product shall be resistant to steam sterilization at 121 deg C of 134 deg C.
Shelf life 5 years
Instructions for use:
For maintenance of a clear oral airway by preventing blockage by the tongue.
The choice of an oral-pharyngeal Cannula must take into account the size and anatomical configuration of the oropharynx, as these can vary greatly from one person to another.
Packaging and labelling:
One (1) airway Guedel in a plastic bag.
Symbols used according ISO 15223
CE mark
Primary pack labelling shall be as per the device classification and regulatory compliance applied to the device.
Regulatory & Conformity Requirements:
CE mark Comply to EU Council Directive 93/42/EEC (MDD) of EU Regulations 2017/745 (MDR) with valid EC Certificate and Declaration of Conformity for the CE mark is applicable.
US FDA 510(K) clearance
CE certificate available for Class IIa and above devices
Manufacturer’s Quality Management System is certified to ISO 13485 : 2016
Supplied with:
Manufacturer's instruction for use.
Safety & product Standards (as per latest revision):
Must comply with the following standards :
EN ISO 5364: 2016: Anaesthetic and respiratory equipment - Oropharyngeal airways (5th edition)
ISO 18190: 2016: Anaesthetic and respiratory equipment - General requirements for airways and related equipment
ISO10993-1: Biological safety testing
| Pack Size | Avg. Price |
|---|---|
| Pack of 1 | $0.18 |
