UroShield® User Manual
20-100-0022 Ver. 02
5
Disclaimer for Physicians and Patients
in the USA
The UroShield has neither been cleared or approved to aid in the
reduction of catheter-associated urinary tract infection (CAUTI)
incidence in patients requiring long-term (≥ 14 days) indwelling
catheterization.
The UroShield is under Enforcement Discretion for use during the
COVID-19 epidemic; and,
The UroShield is under Enforcement Discretion only for the duration of
the declaration that circumstances exist justifying the authorization of
the emergency use of medical devices under section 564(b)(1) of the
Act, 21 U.S.C. § 360bbb-3(b)(1)
Note for Healthcare Facilities:
Healthcare facilities using the UroShield should make available to
patients the accompanying Patient Insert and healthcare providers the
accompanying Healthcare Provider Insert.
Healthcare facilities using the UroShield should make NanoVibronix,
Inc., and FDA aware of any adverse events under 21 CFR Part 803.
Healthcare facilities should ensure healthcare providers using the
UroShield are adequately equipped, trained, capable, and will
maintain records of device usage
