UroShield Kit 10-200-0004

GUDID 07290103420260

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).

NANOVIBRONIX INC.

Urinary catheter ultrasonic bacterial adhesion inhibition system Urinary catheter ultrasonic bacterial adhesion inhibition system Urinary catheter ultrasonic bacterial adhesion inhibition system Urinary catheter ultrasonic bacterial adhesion inhibition system Urinary catheter ultrasonic bacterial adhesion inhibition system Urinary catheter ultrasonic bacterial adhesion inhibition system Urinary catheter ultrasonic bacterial adhesion inhibition system Urinary catheter ultrasonic bacterial adhesion inhibition system Urinary catheter ultrasonic bacterial adhesion inhibition system Urinary catheter ultrasonic bacterial adhesion inhibition system Urinary catheter ultrasonic bacterial adhesion inhibition system Urinary catheter ultrasonic bacterial adhesion inhibition system Urinary catheter ultrasonic bacterial adhesion inhibition system Urinary catheter ultrasonic bacterial adhesion inhibition system
Primary Device ID07290103420260
NIH Device Record Key0b479ec3-27e0-46a6-b3b6-e8bc4a4263f7
Commercial Distribution StatusIn Commercial Distribution
Brand NameUroShield Kit
Version Model Number3.0
Catalog Number10-200-0004
Company DUNS080326793
Company NameNANOVIBRONIX INC.
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusMR Unsafe
Human Cell/Tissue Productfalse
Device Kittrue
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numbertrue
Manufacturing Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone(914) 233 3004
Emailinfo@nanovibronix.com
Phone(914) 233 3004
Emailinfo@nanovibronix.com
Phone(914) 233 3004
Emailinfo@nanovibronix.com
Phone(914) 233 3004
Emailinfo@nanovibronix.com
Phone(914) 233 3004
Emailinfo@nanovibronix.com
Phone(914) 233 3004
Emailinfo@nanovibronix.com
Phone(914) 233 3004
Emailinfo@nanovibronix.com
Phone(914) 233 3004
Emailinfo@nanovibronix.com
Phone(914) 233 3004
Emailinfo@nanovibronix.com
Phone(914) 233 3004
Emailinfo@nanovibronix.com
Phone(914) 233 3004
Emailinfo@nanovibronix.com
Phone(914) 233 3004
Emailinfo@nanovibronix.com
Phone(914) 233 3004
Emailinfo@nanovibronix.com
Phone(914) 233 3004
Emailinfo@nanovibronix.com

Device Identifiers

Device Issuing AgencyDevice ID
GS107290103420260 [Primary]

FDA Product Code

QMKExtracorporeal Acoustic Wave Generating Accessory To Urological Indwelling Catheter For Use During The Covid-19 Pandemic

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-12-30
Device Publish Date2020-12-22

Devices Manufactured by NANOVIBRONIX INC.

07290103420277 - UroShield 3.0 Driver2023-08-02 The UroShield driver is an electronic unit intended to drive an accessory (Ultrasonic Actuator) that creates surface acoustic wa
07290103422011 - PainShield Patch2023-08-01 PainShield patch is a component of the PainShield MD system.
07290103421144 - PainShield 3.0 Actuator2023-07-24 PainShield actuator is part of the PainShield MD System.
07290103421328 - PainShield Plus Actuator 2023-07-24 PainShield Plus Actuator is part of the PainShield Plus system.
07290103422028 - PainShield 3.0 Driver 2023-07-24 PainShield MD applies ultrasound energy through a treatment patch that is placed at, or close to, the center of the painful area
07290103422035 - PainShield Plus 3.0 Driver 2023-07-24 PainShield MD Plus is intended to apply ultrasonic energy to generate deep heat within body tissues for the treatment of selecte
07290103421014 - PainShield2022-11-14 PainShield MD applies ultrasound energy through a treatment patch that is placed at, or close to, the center of the painful area
07290103421267 - PainShield MD Plus Monnthly kit2022-05-24 The Monthly kit includes a treatment actuator that incorporates an ultrasonic transducer and connects to the driver with a cable
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