pjur Aqua

GUDID 40827160100252

Water-based Personal Lubricant

Pjur Group Luxembourg SA

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: 40827160100252
• NIH Device Record Key: b3c71b44-eb97-4f06-8a5b-4a0b577a4b14
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: pjur Aqua
• Version Model Number: pjur Aqua 2 ml - USA (50 pcs.)
• Company DUNS: 400744553
• Company Name: Pjur Group Luxembourg SA
• 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	00827160100254 [Primary]
GS1	40827160100252 [Package]; Contains: 00827160100254; Package: case [20 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K010199

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: 2018-08-09
• Device Publish Date: 2017-01-25

On-Brand Devices [pjur Aqua]

• 40827160110107: Water-based Personal Lubricant
• 40827160110091: Water-based Personal Lubricant
• 40827160110084: Water-based Personal Lubricant
• 40827160100252: Water-based Personal Lubricant