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Item Number (DPCI): 245-07-0335
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Been looking for some replacement carbon filters for your filter pocket equipped mask? We’ve got you covered with the ICU Health Carbon Filter Mask Insert. The Carbon Filter Mask Insert is made from non-woven, splash proof fiber on either outer side, with melt blown polypropylene inner layers which surround a non-woven, activated carbon filter layer in the very middle. Carbon Filters made from Particular Matter 2.5 are proven, effective combatants to airborne fluid transmissions, as well as for countering smoke. Each ICU Health 5-Layer Carbon Filter Mask Insert Box contains 30 replacement filters compatible with any mask with a filter pocket. Filter replacements are in the shape of a rounded rectangle and measure approximately 3 and 1/8 inches tall by 4 and ¾ inches wide.
• The product has not been FDA cleared or approved
• The product has been authorized by FDA under an EUA for use as source control by the general public as well as by HCP in healthcare settings as to help prevent the spread of infection or illness during the -19 pandemic.
• This product is authorized only for the duration of the declaration that circumstances exist justifying the authorization of the emergency use of medical devices, including alternative products used as medical devices, during the -19 outbreak, under section 564(b)(1) of the Act, 21 U.S.C. § 360bbb-3(b)(1) unless the authorization is terminated or revoked sooner.
Not recommended for use in any surgical setting or where significant exposure to liquid, bodily or other hazardous fluids may be expected, or use in a clinical setting where the infection risk level through inhalation exposure is high, or use in the presence of a high intensity heat source or flammable gas.
The 5-Layer Carbon Filters are manufactured in China for ICU Health, an FDA registered company located in Hollister, California, USA.