Diva Lubricator

GUDID 00841445001111

This device is a personal lubricant, for penile and/or vaginal application, intended to moisturize and lubricate, to enhance the ease and comfort of intimate sexual activity, and supplement the body's natural lubrication. This product may or may not be compatible with natural rubber latex, polyisoprene, and/or polyurethane condoms.

Diva International Inc

Sexual lubricant

• Primary Device ID: 00841445001111
• NIH Device Record Key: cc62407e-06cd-420d-ba62-6363f84ae1b3
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Diva Lubricator
• Version Model Number: 1
• Company DUNS: 207651758
• Company Name: Diva International Inc
• 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: false
• 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: false

Customer Support Contacts

• Phone: 18664443482
• Email: qaregulatory@divacup.com
• Phone: 18664443482
• Email: qaregulatory@divacup.com
• Phone: 18664443482
• Email: qaregulatory@divacup.com
• Phone: 18664443482
• Email: qaregulatory@divacup.com
• Phone: 18664443482
• Email: qaregulatory@divacup.com
• Phone: 18664443482
• Email: qaregulatory@divacup.com
• Phone: 18664443482
• Email: qaregulatory@divacup.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00841445001111 [Primary]
GS1	10841445000692 [Package]; Package: Case Pack [6 Units]; In Commercial Distribution
GS1	20841445000491 [Package]; Contains: 10841445000692; Package: Master Case [36 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K182027

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: 2025-04-09
• Device Publish Date: 2025-04-01

On-Brand Devices [Diva Lubricator]

• 00841445001104: This device is a personal lubricant, for penile and/or vaginal application, intended to moisturi
• 00841445001111: This device is a personal lubricant, for penile and/or vaginal application, intended to moisturi