Supraglottic Airways Device (3rd Generation)

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Type of Certifications for product CE
Certification no and date to be indicated CE 0805 29.04.2014 28.04.2019

Performance Parameters

Application Supraglottic airway devices (SADs) are used to keep the upper airway open to provide unobstructed ventilation
Type of use Single use disposable
Airways device should deliver consistently very high IPPV (intermittent positive-pressure ventilation) Yes
Device should be easy to insert and clean the contents of the pharyngeal cavity instantly Yes
Device should not inflate the stomach during IPPV Yes
Device should have attachments for suction to keep sump area clear Yes
Size of Supraglottic airway device “3 (for children 30- 50 Kg – Inflation volume upto 20 mL)”
Device should have bite block for safety Yes
Airways device must provide advanced airway opening for superior patency of seal increased protection against gastric overflow Yes
Advanced self sealing variable pressure cuff Yes
Expanding membranous cuff produce a seal which increases proportionally with increasing airway pressure during IPPV Yes
Device should have large distal aperture locates at upper esophagus and open into sump cavity for easy drainage of gastric fluid Yes


Manufacturer should have ISO certification Yes
ISO certification date and number ISO 13485:2003 29.03.2016
Copies of Relevant certifications tand reports to be furnished to buyer on demand Yes


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