NanoVibronix UroShield User Manual page 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.
CONTENTS
The UroShield
following items:
UroShield Driver.
Clip-on actuator with its connecting cable.
Lanyard.
Power supply charger.
includes the
®
5
1.1
1.2
1