Disclaimers & Legal
- The product has not been FDA cleared or approved.
- The product has been authorized by FDA under an EUA for use by healthcare providers as personal protective equipment.
- This product is only authorized for the duration of the declaration that circumstances justifying the authorization of emergency use under Section 564(b)(1) of the Act, 21 USC 360bbb-3(b)(1) unless the authorization is terminated or revoked sooner.
The scope of this authorization is limited to the use of face shields by HCP as PPE in healthcare settings in accordance with CDC recommendations to cover the front and sides of the face and provide barrier protection during the COVID-19 pandemic. Face shields for use by HCP as PPE are authorized under this EUA when they are intended for use by HCP as PPE in healthcare settings in accordance with CDC recommendations to cover the front and sides of the face and provide barrier protection. This EUA will be effective until the declaration that circumstances exist justifying the authorization of the emergency use of medical devices due to shortages during the COVID-19 outbreak is terminated under Section 564(b)(2) of the Act or the EUA is revoked under Section 564(g) of the Act.
CoResearch Incorporated “CoResearch” MAKES NO REPRESENTATIONS AND EXTENDS NO WARRANTIES OF ANY KIND, EXPRESS OR IMPLIED, REGARDING THE FACE SHIELDS OR THEIR DESIGN, AND MAKES NO EXPRESS OR IMPLIED WARRANTIES OF ANY KIND, INCLUDING, BUT NOT LIMITED TO, ANY WARRANTIES OF MERCHANTABILITY, TITLE, FITNESS, ADEQUACY OR SUITABILITY FOR A PARTICULAR PURPOSE, USE OR RESULT; ANY WARRANTIES OF FREEDOM FROM INFRINGEMENT OF ANY DOMESTIC OR FOREIGN PATENTS, COPYRIGHTS, TRADE SECRETS OR OTHER PROPRIETARY RIGHTS OF ANY PARTY; AND ANY WARRANTIES THAT THE FACE SHIELDS WILL PERFORM OR COMPLY WITH FEDERAL OR STATE LAWS AND REGULATIONS REGARDING MEDICAL SUPPLIES OR MEDICAL USES. CoResearch shall not be liable for any claims, demands, damages, liabilities, or injuries, including, without limitation, for property damage, bodily injury, or death, or for any indirect, special, or consequential damages (the “Claims”), arising out of or in connection with the condition, performance, ownership, use of, or inability to use, the face shields. To the extent the PREP Act does not apply, Recipient and/or user is exclusively responsible for the inspection, storage, transfer, disposal, and/or use of the face shields and any Claims resulting therefrom. ALL PRODUCT, PRODUCT INFORMATION AND DATA ARE SUBJECT TO CHANGE WITHOUT NOTICE.