JO Gelato Mint Chocolate 1oz/30ml

GUDID B362410220

Water-based Personal Lubricant

United Consortium

Sexual lubricant

• Primary Device ID: B362410220
• NIH Device Record Key: fa1c84cb-0107-45a6-ae80-9053a70514ac
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: JO Gelato Mint Chocolate 1oz/30ml
• Version Model Number: 41022
• 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
GS1	00851271008031 [Primary]
GS1	00851271008048 [Package]; Contains: 00851271008031; Package: [12 Units]; In Commercial Distribution
HIBCC	B362410220 [Previous]

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: 3
• Public Version Date: 2019-05-20
• Device Publish Date: 2018-07-11

On-Brand Devices [JO Gelato Mint Chocolate 1oz/30ml]

• B362410220: Water-based Personal Lubricant
• B362410221: Water-based Personal Lubricant