FDA UDI
In Commercial Distribution
🇺🇸 United States
UroShield Actuaor 10 pack
DI: 07290103420123
·
Model: 3.0 Actuator
·
NANOVIBRONIX INC.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- UroShield Actuaor 10 pack
- Primary DI
- 07290103420123
- Version / Model
- 3.0 Actuator
- Catalog Number
- 10-200-0002
- Company Name
- NANOVIBRONIX INC.
- Labeler DUNS
- 080326793
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2021-05-04
- Public Version
- 1
- Public Version Date
- 2021-05-12
- Public Version Status
- New
- Public Device Record Key
- 24d75dab-ab88-424e-b373-fafc180429be
Device Description
A package of 10 x UroShield disposable Actuators The UroShield 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.
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- Yes
- 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
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- Has Expiration Date
- Yes
- 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 The Covid-19 Pandemic |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 63693 | Urinary catheter ultrasonic bacterial adhesion inhibition system actuator | A 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. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 07290103420123 | GS1 |
Customer Contacts
- Phone
- (914) 233 3004
- [email protected]