Identity
- Trade Name
- Mia Vita FDA UDI
- Generic Name
- Sexual lubricant FDA UDI
- Device Name
- Mia Vita vaginal moisturizer and personal lubricant is a non-sterile, water-based, white to off-white, non-irritating, non-greasy, non-staining low volume gel delivered in a single use disposable applicator for vaginal dryness. The applicator provides convenience and provides for less mess during application. Mia Vita vaginal moisturizer and personal lubricant is intended for ongoing use, not exclusively for use during intimate sexual activity. Mia Vita vaginal moisturizer and personal lubricant contains ingredients commonly used in other products for intravaginal use sold as medical devices and cosmetics. All ingredients used are approved high quality pharmaceutical grade, and considered "generally recognized as safe for their intended use" by the FDA. The quantitative formulation is considered confidential commercial information. FDA UDI
- Model / Reference
- 01 FDA UDI
- Description
- Mia Vita vaginal moisturizer and personal lubricant is a non-sterile, water-based, white to off-white, non-irritating, non-greasy, non-staining low volume gel delivered in a single use disposable applicator for vaginal dryness. The applicator provides convenience and provides for less mess during application. Mia Vita vaginal moisturizer and personal lubricant is intended for ongoing use, not exclusively for use during intimate sexual activity. Mia Vita vaginal moisturizer and personal lubricant contains ingredients commonly used in other products for intravaginal use sold as medical devices and cosmetics. All ingredients used are approved high quality pharmaceutical grade, and considered "generally recognized as safe for their intended use" by the FDA. The quantitative formulation is considered confidential commercial information. FDA UDI
Identifiers
- Catalog Number
- 01 FDA UDI
- Primary DI / UDI-DI
- 00850035529003 FDA UDI
- 510(k) Number
- K190752 FDA UDI
- FDA Product Code
- NUC FDA UDI
- GMDN Term
- Sexual lubricant FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 884.5300 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
Yes
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: Sexual lubricant
Mia Vita by Femmepharma Consumer Healthcare, LLC — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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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
- Femmepharma Consumer Healthcare, LLC
Sources (1)
- FDA UDI 1a3bf877-a960-467d-a48e-0d91bbe1c410 36 fields · synced May 30, 2026