JO Agape Original 1oz/30ml

GUDID B362410411

Water-based Personal Lubricant

United Consortium

Sexual lubricant

• Primary Device ID: B362410411
• NIH Device Record Key: 5305b4c0-09c9-4cef-bc60-387ae7a50656
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: JO Agape Original 1oz/30ml
• Version Model Number: 41041
• 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	B362410410 [Primary]
HIBCC	B362410411 [Package]; Contains: B362410410; Package: [24 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

Devices Manufactured by United Consortium

• B362410201 - JO Gelato Creme Brulee 1oz/30ml: 2019-05-20 Water-based Personal Lubricant
• B362410211 - JO Gelato Hazelnut Espresso 1oz/30ml: 2019-05-20 Water-based Personal Lubricant
• B362410221 - JO Gelato Mint Chocolate 1oz/30ml: 2019-05-20 Water-based Personal Lubricant
• B362410231 - JO Gelato Salted Caramel 1oz/30ml: 2019-05-20 Water-based Personal Lubricant
• B362410241 - JO Gelato Tiramisu 1oz/30ml: 2019-05-20 Water-based Personal Lubricant
• B362440201 - JO Gelato Creme Brulee 4oz/120ml: 2019-05-20 Water-based Personal Lubricant
• B362440211 - JO Gelato Hazelnut Espresso 4oz/120ml: 2019-05-20 Water-based Personal Lubricant
• B362440221 - JO Gelato Mint Chocolate 4oz/120ml: 2019-05-20 Water-based Personal Lubricant