AccessGUDID - DEVICE: UroShield Kit (07290103420260)

GUDID

Device Identifier (DI) Information

Brand Name: UroShield Kit
Version or Model: 3.0
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 10-200-0004
Company Name: NANOVIBRONIX INC.

Primary DI Number: 07290103420260
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 080326793 *Terms of Use

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

What MRI safety information does the labeling contain?	MR Unsafe
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	No
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	Yes
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
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.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
QMK	Extracorporeal Acoustic Wave Generating Accessory To Urological Indwelling Catheter For Use During The Covid-19 Pandemic

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: Yes CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 0b479ec3-27e0-46a6-b3b6-e8bc4a4263f7
Public Version Date: December 30, 2020
Public Version Number: 1
DI Record Publish Date: December 22, 2020