Lubefy

GUDID 00860012900404

SILICONE Personal Lubricant 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 is compatible with natural rubber latex and polyisoprene condoms. This product is not compatible with polyurethane condoms.

Bath Concept Cosmetics (DongGuan) Co., Ltd.

Sexual lubricant

• Primary Device ID: 00860012900404
• NIH Device Record Key: 3c3c4bcb-2394-499e-b0f7-ff8d2e57da85
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Lubefy
• Version Model Number: silicone based lubricant
• Company DUNS: 529623933
• Company Name: Bath Concept Cosmetics (DongGuan) Co., Ltd.
• 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: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: true

Device Identifiers

Device Issuing Agency	Device ID
GS1	00860012900404 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K191654

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: 2024-10-15
• Device Publish Date: 2024-10-07

Devices Manufactured by Bath Concept Cosmetics (DongGuan) Co., Ltd.

• 00860012900411 - First Release: 2026-03-18 First Release Silicone-based Personal Lubricant is a personal lubricant, for penile and/or vaginal application, intended to mois
• 00860012900404 - Lubefy: 2024-10-15SILICONE Personal Lubricant 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 is compatible with natural rubber latex and polyisoprene condoms. This product is not compatible with polyurethane condoms.
• 00860012900404 - Lubefy: 2024-10-15 SILICONE Personal Lubricant is a personal lubricant, for penile and/or vaginal application, intended to moisturize and lubricate