JO Agape Original 2oz/60ml

GUDID B362420080

Water-based Personal Lubricant

United Consortium

Sexual lubricant

• Primary Device ID: B362420080
• NIH Device Record Key: 98dc12b6-9935-4dc9-897f-b2ab1735a537
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: JO Agape Original 2oz/60ml
• Version Model Number: 42008
• Company DUNS: 067692292
• Company Name: United Consortium
• 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
HIBCC	B362420080 [Primary]
HIBCC	B362420081 [Package]; Package: [12 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K171021

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: 4
• Public Version Date: 2018-11-19
• Device Publish Date: 2018-05-21

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