JO Gelato Creme Brulee .1oz/3ml

GUDID B362701251

Water-based Personal Lubricant

United Consortium

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 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 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: B362701251
• NIH Device Record Key: 416f9f66-163d-4d38-b0d6-d4ee24e0be6f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: JO Gelato Creme Brulee .1oz/3ml
• Version Model Number: 70125
• 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	B362701250 [Primary]
HIBCC	B362701251 [Package]; Contains: B362701250; Package: [12 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K172447

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: 5
• Public Version Date: 2019-05-20
• 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