Identity
- Trade Name
- Revive FDA UDI
- Generic Name
- Urinary-incontinence vaginal insert, reusable FDA UDI
- Device Name
- The Revive reusable bladder support is intended for temporary management of urinary leakage caused by stress urinary incontinence (SUI) in women, 18 years and older. FDA UDI
- Model / Reference
- 0025 FDA UDI
- Description
- The Revive reusable bladder support is intended for temporary management of urinary leakage caused by stress urinary incontinence (SUI) in women, 18 years and older. FDA UDI
Identifiers
- Catalog Number
- 0025 FDA UDI
- Primary DI / UDI-DI
- 00854389008009 FDA UDI
- 510(k) Number
- K183468 FDA UDI
- FDA Product Code
- HHW FDA UDI
- GMDN Term
- Urinary-incontinence vaginal insert, reusable FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 884.3575 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
FDA UDI
Over-the-Counter
Yes
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Urinary-incontinence vaginal insert, reusable
Revive by Rinovum Subsidiary 2, Llc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Urinary-incontinence vaginal insert, reusable.
- Uresta® — Resilia, Inc. · Class II
- Yoni.Fit Bladder Support — Watkins-Conti Products, Inc. · Class II
- Uresta® — Resilia, Inc. · Class II
- Yoni.Fit Bladder Support — Watkins-Conti Products, Inc. · Class II
- Yoni.Fit Bladder Support — Watkins-Conti Products, Inc. · Class II
- Uresta® — Resilia, Inc. · Class II
- Yoni.Fit Bladder Support — Watkins-Conti Products, Inc. · Class II
- Yoni.Fit Bladder Support — Watkins-Conti Products, Inc. · Class II
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Rinovum Subsidiary 2, Llc
Sources (1)
- FDA UDI 3e1a4340-7ee8-4073-9dc2-288285337dc5 36 fields · synced Jun 6, 2026