FDA UDI
In Commercial Distribution
🇺🇸 United States
UroShield 3.0 Driver
DI: 07290103420277
·
Model: 3.0
·
NANOVIBRONIX INC.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- UroShield 3.0 Driver
- Primary DI
- 07290103420277
- Version / Model
- 3.0
- Catalog Number
- 10-800-0003
- Company Name
- NANOVIBRONIX INC.
- Labeler DUNS
- 080326793
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2023-07-25
- Public Version
- 1
- Public Version Date
- 2023-08-02
- Public Version Status
- New
- Public Device Record Key
- c187b437-af95-4b54-a6cc-5975a19dcb3f
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).
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- MR Unsafe
- Direct Marking Exempt
- No
- PM Exempt
- Yes
- Has Serial Number
- Yes
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- Yes
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| QMK | Extracorporeal Acoustic Wave Generating Accessory To Urological Indwelling Catheter For Use During Public Health Emergen |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 63691 | Urinary catheter ultrasonic bacterial adhesion inhibition system | An 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. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 07290103420277 | GS1 |
Customer Contacts
- Phone
- 914-233-3004
- [email protected]
Storage Conditions
- Type
- Storage Environment Humidity
- Temperature Range
- 10 – 80 Percent (%) Relative Humidity
- Type
- Storage Environment Temperature
- Temperature Range
- 5 – 40 Degrees Celsius