Mia Vita 01

GUDID 00850035529003

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.

FEMMEPHARMA CONSUMER HEALTHCARE LLC

Sexual lubricant Sexual lubricant Sexual lubricant Sexual lubricant Sexual lubricant Sexual lubricant Sexual lubricant Sexual lubricant Sexual lubricant Sexual lubricant Sexual lubricant Sexual lubricant Sexual lubricant Sexual lubricant Sexual lubricant Sexual lubricant

• Primary Device ID: 00850035529003
• NIH Device Record Key: 1a3bf877-a960-467d-a48e-0d91bbe1c410
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Mia Vita
• Version Model Number: 01
• Catalog Number: 01
• Company DUNS: 116647151
• Company Name: FEMMEPHARMA CONSUMER HEALTHCARE LLC
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: false
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: true

Customer Support Contacts

• Phone: 610-995-0801
• Email: support@femmepharma.com
• Phone: 610-995-0801
• Email: support@femmepharma.com
• Phone: 610-995-0801
• Email: support@femmepharma.com
• Phone: 610-995-0801
• Email: support@femmepharma.com
• Phone: 610-995-0801
• Email: support@femmepharma.com
• Phone: 610-995-0801
• Email: support@femmepharma.com
• Phone: 610-995-0801
• Email: support@femmepharma.com
• Phone: 610-995-0801
• Email: support@femmepharma.com
• Phone: 610-995-0801
• Email: support@femmepharma.com
• Phone: 610-995-0801
• Email: support@femmepharma.com
• Phone: 610-995-0801
• Email: support@femmepharma.com
• Phone: 610-995-0801
• Email: support@femmepharma.com
• Phone: 610-995-0801
• Email: support@femmepharma.com
• Phone: 610-995-0801
• Email: support@femmepharma.com
• Phone: 610-995-0801
• Email: support@femmepharma.com
• Phone: 610-995-0801
• Email: support@femmepharma.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00850035529003 [Primary]
GS1	00850035529010 [Package]; Package: Bag [3 Units]; In Commercial Distribution
GS1	00850035529027 [Package]; Package: Bag [3 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K190752

FDA Product Code

• NUC: Lubricant, Personal

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2022-11-24
• Device Publish Date: 2022-11-16

Devices Manufactured by FEMMEPHARMA CONSUMER HEALTHCARE LLC

• 00850035529003 - Mia Vita: 2022-11-24Mia 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.
• 00850035529003 - Mia Vita: 2022-11-24 Mia Vita vaginal moisturizer and personal lubricant is a non-sterile, water-based, white to off-white, non-irritating, non-greas
• 00860000221511 - Satisfaite: 2020-08-07 Satisfaite vaginal moisturizer and personal lubricant is a non-sterile, water-based, white to off-white, non-irritating, non-g