UroShield Actuator

Primary DI
07290103420116
Brand
UroShield Actuator
Company
NANOVIBRONIX INC.
Model
3.0 actuator
Catalog number
10-600-0003
Device description
The UroShield disposable Actuator is a single catheter use accessory that is clipped on the catheter's external part.After connection to the reusable Driver and activation, Actuator creates surface acoustic waves that cause small acoustic vibrations on the catheter surface to prevent bacteria adhesion to the catheter surface.
Published
2020-12-22
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
QMKExtracorporeal Acoustic Wave Generating Accessory To Urological Indwelling Catheter For Use During The Covid-19 Pandemic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
QMKExtracorporeal Acoustic Wave Generating Accessory To Urological Indwelling Catheter For Use During The Covid-19 Pandemic

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07290103420116PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07290103420116072901034201167290103420116

GMDN Terms#

Term, Definition table
TermDefinition
Urinary catheter ultrasonic bacterial adhesion inhibition system actuatorA non-sterile, portable, noninvasive device designed to generate and 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 is a small unit with a transducer and integrated ultrasonic actuator intended to be attached (e.g., clipped onto) the catheter. It is designed to be used with a system control unit (not included) from which it is controlled and draws power. This is a single-use device.

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
Kit
true
Lot or batch
true
Expiration 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
07290103420277UroShield 3.0 Driver3.010-800-00032023-07-25
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
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
07290103420277UroShield 3.0 DriverNANOVIBRONIX INC.QMK2023-07-25
07290103420123UroShield Actuaor 10 packNANOVIBRONIX INC.QMK2021-05-04
07290103420260UroShield KitNANOVIBRONIX INC.QMK2020-12-22