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

• Primary Device ID: 07290103420260
• NIH Device Record Key: 0b479ec3-27e0-46a6-b3b6-e8bc4a4263f7
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: UroShield Kit
• Version Model Number: 3.0
• Catalog Number: 10-200-0004
• Company DUNS: 080326793
• Company Name: NANOVIBRONIX INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• MRI Safety Status: MR Unsafe
• Human Cell/Tissue Product: false
• Device Kit: true
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: (914) 233 3004
• Email: info@nanovibronix.com
• Phone: (914) 233 3004
• Email: info@nanovibronix.com
• Phone: (914) 233 3004
• Email: info@nanovibronix.com
• Phone: (914) 233 3004
• Email: info@nanovibronix.com
• Phone: (914) 233 3004
• Email: info@nanovibronix.com
• Phone: (914) 233 3004
• Email: info@nanovibronix.com
• Phone: (914) 233 3004
• Email: info@nanovibronix.com
• Phone: (914) 233 3004
• Email: info@nanovibronix.com
• Phone: (914) 233 3004
• Email: info@nanovibronix.com
• Phone: (914) 233 3004
• Email: info@nanovibronix.com
• Phone: (914) 233 3004
• Email: info@nanovibronix.com
• Phone: (914) 233 3004
• Email: info@nanovibronix.com
• Phone: (914) 233 3004
• Email: info@nanovibronix.com
• Phone: (914) 233 3004
• Email: info@nanovibronix.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	07290103420260 [Primary]

FDA Product Code

• QMK: Extracorporeal Acoustic Wave Generating Accessory To Urological Indwelling Catheter For Use During The Covid-19 Pandemic

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2020-12-30
• Device Publish Date: 2020-12-22

Devices Manufactured by NANOVIBRONIX INC.

• 07290103420277 - UroShield 3.0 Driver: 2023-08-02 The UroShield driver is an electronic unit intended to drive an accessory (Ultrasonic Actuator) that creates surface acoustic wa
• 07290103422011 - PainShield Patch: 2023-08-01 PainShield patch is a component of the PainShield MD system.
• 07290103421144 - PainShield 3.0 Actuator: 2023-07-24 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 - PainShield: 2022-11-14 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 kit: 2022-05-24 The Monthly kit includes a treatment actuator that incorporates an ultrasonic transducer and connects to the driver with a cable