Doc no: PT00098114 Revision A Aircraft Medical Ltd © 2019 www.medtronic.com/mac-first
Disposable Laryngoscope Blade
The device must be used only with McGRATH® disposable laryngoscope blades
Material Medical grade optical polymer
Packaging Packaged sterile for single use only
This device and packaging are latex free
1.4 Regulatory
This product complies with ISO 7376, EN 60601-1 and EN 60601-1-2 safety standards. The
CE mark indicates that it meets the requirements of European Council Directives 93/42/EEC
and 2007/47/EC concerning medical devices.
In addition to the above compliance, sterility aspects of the McGRATH® Disposable
Laryngoscope Blade have been certified by Aircraft Medical’s notified body.
The McGRATH® Disposable Laryngoscope Blade is classified as a type BF applied part in
accordance with section 8.3 of EN60601-1.
The device is regulated in the USA under FDA Regulation Number 868.5540 and device listed under
the name McGRATH® MAC.
“McGRATH” is a registered trademark of Aircraft Medical Limited.
“Aircraft” is a registered trademark of Aircraft Medical Limited.
“CameraStick” is a trademark of Aircraft Medical Limited.
“X blade” and “X3” are trademarks of Aircraft Medical Limited.
“E.T. CONTACT ZONE” is a trademark of Aircraft Medical Limited.
“DepthGuide” is a trademark of Aircraft Medical Limited.
Only personnel trained in and licensed to perform intubation with a laryngoscope may use this device.
The user must contact their Aircraft Medical agent or distributor to arrange responsible
disposal and compliance with Waste Electrical and Electronic Equipment regulations
applicable, and any similar future environmental regulation applicable (including but not
limited to Directives 2002/95/EC and 2002/96/EC as implemented in the country of use).
CAUTION : FEDERAL (USA) LAW RESTRICTS THIS DEVICE TO SALE BY OR ON THE
ORDER OF A LICENSED PRACTITIONER
5
To Next Page
Loading...
