UroShield 3.0 Driver 10-800-0003

GUDID 07290103420277

The UroShield driver is an electronic unit intended to drive an accessory (Ultrasonic Actuator) that creates surface acoustic waves on Urinary catheter to prevent bacterial adhesion and minimized risk of CAUTI (Catheter Associated Urinary Tract Infections).

NANOVIBRONIX INC.

Urinary catheter ultrasonic bacterial adhesion inhibition system
Primary Device ID07290103420277
NIH Device Record Keyc187b437-af95-4b54-a6cc-5975a19dcb3f
Commercial Distribution StatusIn Commercial Distribution
Brand NameUroShield 3.0 Driver
Version Model Number3.0
Catalog Number10-800-0003
Company DUNS080326793
Company NameNANOVIBRONIX INC.
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusMR Unsafe
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numbertrue
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone914-233-3004
Emailinfo@nanovibronix.com
Phone914-233-3004
Emailinfo@nanovibronix.com
Phone914-233-3004
Emailinfo@nanovibronix.com
Phone914-233-3004
Emailinfo@nanovibronix.com
Phone914-233-3004
Emailinfo@nanovibronix.com
Phone914-233-3004
Emailinfo@nanovibronix.com
Phone914-233-3004
Emailinfo@nanovibronix.com
Phone914-233-3004
Emailinfo@nanovibronix.com
Phone914-233-3004
Emailinfo@nanovibronix.com
Phone914-233-3004
Emailinfo@nanovibronix.com
Phone914-233-3004
Emailinfo@nanovibronix.com
Phone914-233-3004
Emailinfo@nanovibronix.com
Phone914-233-3004
Emailinfo@nanovibronix.com
Phone914-233-3004
Emailinfo@nanovibronix.com
Phone914-233-3004
Emailinfo@nanovibronix.com
Phone914-233-3004
Emailinfo@nanovibronix.com
Phone914-233-3004
Emailinfo@nanovibronix.com
Phone914-233-3004
Emailinfo@nanovibronix.com

Operating and Storage Conditions

Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS107290103420277 [Primary]

FDA Product Code

QMKExtracorporeal Acoustic Wave Generating Accessory To Urological Indwelling Catheter For Use During Public Health Emergen

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2023-08-02
Device Publish Date2023-07-25

Devices Manufactured by NANOVIBRONIX INC.

07290103420277 - UroShield 3.0 Driver2023-08-02The UroShield driver is an electronic unit intended to drive an accessory (Ultrasonic Actuator) that creates surface acoustic waves on Urinary catheter to prevent bacterial adhesion and minimized risk of CAUTI (Catheter Associated Urinary Tract Infections).
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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