Ambu+ Ambu products where no shelf life on product label: - Ambu Resuscitator: Mark IV, SPUR II, Oval + Ambu Facemasks: Transparent Silicone Face mask ‘Ambu has evaluated it as not applicable for these products to state shelf fe on the product label. This evaluation is based upon: + Shelf life testing ofthe products. = The product risk evaluation based on feedback from the use of the products, {Evaluation of the market standard has concluded that shel lite isin general not part of product labeling ofthis kind of products, ‘The actual shelf life of the product does depend on external factors such as the storage conditions. ‘According to the Instruction For Use, the user i to perform a functional test ofthe products after unpacking the device and/or in case of reusable products after reprocessing ofthe device, see the product specie Instruction Far Use Tor turther information. For and on behalf of ambu A/S, Denmark. 25 August, 2010 NL {ila Strange Lundtor, Regulatory Aas Manager