Supraglottic Airways Device (3rd Generation)

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Description

Standards

Type of Certifications for productCE
Certification no and date to be indicatedCE 0805 29.04.2014 28.04.2019

Performance Parameters

ApplicationSupraglottic airway devices (SADs) are used to keep the upper airway open to provide unobstructed ventilation
Type of useSingle 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 instantlyYes
Device should not inflate the stomach during IPPVYes
Device should have attachments for suction to keep sump area clearYes
Size of Supraglottic airway device“3 (for children 30- 50 Kg – Inflation volume upto 20 mL)”
Device should have bite block for safetyYes
Airways device must provide advanced airway opening for superior patency of seal increased protection against gastric overflowYes
Advanced self sealing variable pressure cuffYes
Expanding membranous cuff produce a seal which increases proportionally with increasing airway pressure during IPPVYes
Device should have large distal aperture locates at upper esophagus and open into sump cavity for easy drainage of gastric fluidYes

Certifications

Manufacturer should have ISO certificationYes
ISO certification date and numberISO 13485:2003 29.03.2016
Copies of Relevant certifications tand reports to be furnished to buyer on demandYes

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