Lubelife - Water Based Cooling - 8oz – International

GUDID 10796494001667

Water-Based Cooling Personal Lubricant

CC Wellness LLC

Sexual lubricant

• Primary Device ID: 10796494001667
• NIH Device Record Key: 1d57f11d-82bd-4c4b-bcfd-f780e13c1e7d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Lubelife - Water Based Cooling - 8oz – International
• Version Model Number: 40812-INT
• Company DUNS: 067692292
• Company Name: CC Wellness 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: 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	00796494001660 [Primary]
GS1	10796494001667 [Package]; Contains: 00796494001660; Package: [72 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K210986

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: 2023-04-11
• Device Publish Date: 2023-04-03

Devices Manufactured by CC Wellness LLC

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• 17964944077699 - LubeLife - Water-based 8oz - Retail - 3pk: 2025-07-30 Water-Based Personal Lubricant
• 17964944078993 - LubeLife - Strawberry 8oz - Retail - 3pk: 2025-07-30 Water-Based Personal Lubricant
• 10796494401375 - Spencer's/LubeLife Water-based Aloe 8oz: 2025-07-25 Water-Based Personal Lubricant
• 10796494401702 - Shibari - Lubricant - Agape w/Aloe - 4oz/120ml: 2025-07-25 Water-Based Personal Lubricant