UroShield Kit

Basic Information

• Brand Name: UroShield Kit
• Primary DI: 07290103420260
• Version / Model: 3.0
• Catalog Number: 10-200-0004
• Company Name: NANOVIBRONIX INC.
• Labeler DUNS: 080326793
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2020-12-22
• Public Version: 1
• Public Version Date: 2020-12-30
• Public Version Status: New
• Public Device Record Key: 0b479ec3-27e0-46a6-b3b6-e8bc4a4263f7

Device Description

The UroShield device is a single-patient, extracorporeal accessory to indwelling urinary catheters consisting of a disposable Actuator and a reusable Driver. After the Foley catheter is placed in the patient, the disposable Actuator is clipped on the extracorporeal part of the catheter and then connected to the reusable Driver through the Actuator’s cable connector and Driver’s cable socket connection. When the Driver is turned on, the Actuator creates surface acoustic waves that propagate on the catheter surface. The UroShield surface acoustic waves reduce bacterial adhesion on the catheter surface, thereby designed to minimize the risk of CAUTI (Catheter-Associated Urinary Tract Infections).

Device Characteristics

• Single Use: No
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: Yes
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: MR Unsafe
• Direct Marking Exempt: No
• PM Exempt: Yes
• Has Serial Number: Yes
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
QMK	Extracorporeal Acoustic Wave Generating Accessory To Urological Indwelling Catheter For Use During The Covid-19 Pandemic

GMDN Terms

Code	Name	Definition	Implantable	Status
63691	Urinary catheter ultrasonic bacterial adhesion inhibition system	An assembly of portable, noninvasive, electrically-powered devices designed to deliver ultrasonic vibrations to the external portion of an indwelling urethral catheter to inhibit bacterial attachment/biofilm formation on the catheter surface to reduce risk of infection within the urinary tract; it may in addition be intended to improve patient comfort. It includes a control unit and an ultrasonic actuator intended to be attached (e.g., clipped onto) the catheter. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	07290103420260	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]