JO H2O - Warming - Lubricant 8 floz / 240 mL

GUDID 10796494000424

Water-Based Personal Lubricant

CC Wellness LLC

Sexual lubricant

• Primary Device ID: 10796494000424
• NIH Device Record Key: b309c359-6aaa-4219-b5af-490cd9e18dd7
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: JO H2O - Warming - Lubricant 8 floz / 240 mL
• Version Model Number: 40078
• 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: false
• 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	00796494000427 [Primary]
GS1	10796494000424 [Package]; Contains: 00796494000427; Package: [12 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K210972

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: 2022-09-16
• Device Publish Date: 2022-09-08

Devices Manufactured by CC Wellness LLC

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• 10796494005511 - JO - Foil - H2O Watermelon - 5mL - HMC: 2025-01-22 Water-Based Personal Lubricant
• 10796494005528 - JO - Foil - Strawberry Kisses - 5mL - HMC: 2025-01-22 Water-Based Personal Lubricant
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