JO Agape - Cooling - Lubricant 2 floz / 60 mL

GUDID 10796494001049

Water-Based Personal Lubricant

CC Wellness 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

• Primary Device ID: 10796494001049
• NIH Device Record Key: e6551864-b472-449a-b4c8-4000bd9e2e89
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: JO Agape - Cooling - Lubricant 2 floz / 60 mL
• Version Model Number: 42026
• 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	00796494001042 [Primary]
GS1	10796494001049 [Package]; Contains: 00796494001042; Package: [12 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K200894

FDA Product Code

• NUC: Lubricant, Personal

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2023-04-14
• Device Publish Date: 2022-09-16

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• 10796494004743 - Shibari (Legacy) - Water-based Anal - 8oz: 2024-05-06 Water-Based Personal Lubricant
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