FDA UDI
In Commercial Distribution
🇺🇸 United States
vH Essentials Moisturizing Vaginal Suppositories
DI: M71353960
·
Model: 5396
·
FIDIA FARMACEUTICI SPA
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- vH Essentials Moisturizing Vaginal Suppositories
- Primary DI
- M71353960
- Version / Model
- 5396
- Company Name
- FIDIA FARMACEUTICI SPA
- Labeler DUNS
- 428453013
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2022-09-15
- Public Version
- 1
- Public Version Date
- 2022-09-23
- Public Version Status
- New
- Public Device Record Key
- 672c9486-7adf-4501-b6df-91116d05c80b
Device Description
vH Essentials Moisturizing Vaginal Suppositories are a non-hormonal moisturizer delivered in an easy-to-use suppository format. vH Essentials Moisturizing Vaginal Suppositories, intended for the temporary relief of vaginal dryness symptoms, moisturize and lubricate the vaginal epithelium to enhance the ease and comfort of intimate sexual activity and supplement the body’s natural lubrication. This product is not compatible with natural rubber latex, polyurethane and polyisoprene condoms.
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- Yes
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- No
- 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 |
|---|---|---|---|---|
| NUC | Lubricant, Personal | Obstetrics/Gynecology | 884.5300 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 34131 | Vaginal lubricant | A non-sterile substance (e.g., a gel or jelly) designed to lubricate the vagina to facilitate entry of a gloved finger(s) or a device, e.g., a vaginal speculum, during a diagnostic or therapeutic treatment. This substance will be compatible to the sensitive mucous and tissue of this area. After application, this device cannot be reused. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | M71353960 | HIBCC |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 33 – 77 Degrees Fahrenheit