pjur Original

GUDID 40827160112316

Silicone-based Personal Lubricant

Pjur Group Luxembourg SA

Sexual lubricant

• Primary Device ID: 40827160112316
• NIH Device Record Key: b4acaf16-f92c-49e4-89ad-ec7a2fb40aef
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: pjur Original
• Version Model Number: pjur Original 1000 ml - USA
• 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	00827160112318 [Primary]
GS1	40827160112316 [Package]; Contains: 00827160112318; Package: case [18 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K133233

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 Original]

• 40827160112316: Silicone-based Personal Lubricant
• 40827160112293: Silicone-based Personal Lubricant
• 40827160104779: Silicone-based Personal Lubricant
• 40827160100795: Silicone-based Personal Lubricant
• 40827160100771: Silicone-based Personal Lubricant
• 40827160100757: Silicone-based Personal Lubricant
• 40827160100016: Silicone-based Personal Lubricant
• 10827160114920: Silicone-based Personal Lubricant