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STERRAD®


Emergency Use Authorization (EUA)1


Sterilization Systems received to


decontaminate compatible N95 respirators2 up


to two times, to potentially triple the life span of the single-use respirators.


STERRAD®


Systems


can process over 400 compatible N95 respirators per machine daily*


Cycle times range from 24 minutes – 55 minutes depending on the STERRAD® Sterilization System


STERRAD®


Systems are


designed to enhance safety, compliance and operational efficiency in medical device reprocessing.


*Per 24 hour period on models with cycle times less than 30 minutes.


The ASP STERRAD Sterilization Systems have neither been cleared or approved for the prevention of the COVID-19 infection; the ASP STERRAD Sterilization Systems have been authorized by FDA under an EUA; the ASP STERRAD Sterilization Systems are authorized only for the duration of the declaration that circumstances exist justifying the authorization of the emergency use of the ASP STERRAD Sterilization Systems under section 564(b)(1) of the Act, 21 U.S.C. § 360bbb-3(b)(1), unless the authorization is terminated or revoked sooner.


1


2For purposes of the EUA, “compatible N95 respirators” means any N95 or N95-equivalent respirator that does not contain cellulose-based materials. Respirators containing cellulose-based materials are incompatible with the ASP STERRAD Sterilization Systems.


Protecting patients during their most critical moments.™


Important information: Prior to use, refer to the instructions for use supplied with this device for indications, contraindications, warnings and precautions. Capitalized product names and ALLClear®


are trademarks of ASP Global Manufacturing, GmbH. AP-2000039-1


© ASP 2020. All rights reserved. 33 Technology Dr, Irvine, CA 92618 ASP.com


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