FDA.reportPublic FDA data

UroShield 3.0 Driver

Primary DI
07290103420277
Brand
UroShield 3.0 Driver
Company
NANOVIBRONIX INC.
Model
3.0
Catalog number
10-800-0003
Device description
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).
Published
2023-07-25
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
QMKExtracorporeal Acoustic Wave Generating Accessory To Urological Indwelling Catheter For Use During Public Health Emergen

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
QMKExtracorporeal Acoustic Wave Generating Accessory To Urological Indwelling Catheter For Use During Public Health Emergen

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07290103420277PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07290103420277072901034202777290103420277

GMDN Terms#

Term, Definition table
TermDefinition
Urinary catheter ultrasonic bacterial adhesion inhibition systemAn 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.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Humidity10 Percent (%) Relative Humidity80 Percent (%) Relative Humidity
Storage Environment Temperature5 Degrees Celsius40 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
914-233-3004info@nanovibronix.com

Regulatory Flags#

DUNS number
080326793
Device count
1
Premarket exempt
true
Lot or batch
true
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
07290103422028PainShield 3.0 Driver 3.010-800-00022023-07-16
07290103422035PainShield Plus 3.0 Driver 3.010-800-00062023-07-16
07290103421311PainShield MD Plus3.010-400-00012022-05-16
07290103421236PainShield MD Kit3.010-100-00012020-12-22
07290103421267PainShield MD Plus Supplies Kit3.010-400-00022022-05-16
07290103421168PainShield MD Supplies Kit3.0 10-100-00132020-12-22
07290103422011PainShield Patch3.010-500-00072023-07-24
07290103421144PainShield 3.0 Actuator3.010-600-00022023-07-16
07290103421328PainShield Plus Actuator 3.010-600-00072023-07-16
07290103421014PainShieldPS-302019-07-28
07290103420123UroShield Actuaor 10 pack3.0 Actuator10-200-00022021-05-04
07290103420116UroShield Actuator3.0 actuator10-600-00032020-12-22
07290103420260UroShield Kit3.010-200-00042020-12-22
07290103421229Reusable PatchPRP-202019-07-28
07290103421250Reusable Facial PatchPRP-402019-07-28

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
07290103420123UroShield Actuaor 10 packNANOVIBRONIX INC.QMK2021-05-04
07290103420116UroShield ActuatorNANOVIBRONIX INC.QMK2020-12-22
07290103420260UroShield KitNANOVIBRONIX INC.QMK2020-12-22