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Instructions For Use (IFU) & Fact Sheet


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United States

Instructions for Healthcare Personnel

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Instructions for Healthcare Facilities

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Fact Sheet for Healthcare Personnel

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Canada

Instructions for Healthcare Personnel

English

Download

French

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Instructions for Healthcare Facilities

English

Download

French

Download

Fact Sheet for Healthcare Personnel

English

Download

French

Download


United States Disclaimer:

The ASP STERRAD Sterilization Systems have neither been cleared or approved by FDA, but has been authorized for emergency use by FDA under an EUA for the decontamination of compatible N95 respirators for single-user reuse by HCP to prevent exposure to SARS-CoV-2 and other pathogenic biological airborne particulates;

The emergency use of 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 medical devices during the COVID-19 outbreak, under Section 564(b)(1) of the Federal Food, Drug, and Cosmetic Act, 21 U.S.C. § 360bbb-3(b)(1), unless the declaration is terminated or authorization is revoked sooner.

Canada Disclaimer:

The STERRAD Sterilization Systems have not been licensed or approved for this use by Health Canada but have been authorized under an Interim Order for decontamination of compatible N95 respirators for single-user reuse by healthcare personnel to prevent exposure to SARS-CoV-2 and other pathogenic biological airborne particulates.

The emergency use of the STERRAD Sterilization Systems is authorized only for the duration of the declaration that circumstances exist justifying the authorization of the emergency use of medical devices during the COVID-19 outbreak under the Food and Drugs Act (R.S.C., 1985, c. F-27), s. 30.1 (1) unless the declaration is terminated or authorization is revoked sooner.

If your facility plans to use STERRAD Sterilization Systems for emergency use, please notify us by reaching out to your Account Manager or contact us.