pjur INFINITY silicone-based 13967-02

GUDID 10827160115163

Silicone-based Personal Lubricant

Pjur Group Luxembourg SA

Sexual lubricant

• Primary Device ID: 10827160115163
• NIH Device Record Key: 87da70db-879e-4246-b4b3-cf52fa66046f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: pjur INFINITY silicone-based
• Version Model Number: pjur INFINITY silicone-based, 50ml
• Catalog Number: 13967-02
• 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	00827160115166 [Primary]
GS1	10827160115163 [Package]; Contains: 00827160115166; Package: pack [6 Units]; In Commercial Distribution
GS1	40827160115164 [Package]; Package: case [48 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K133336

FDA Product Code

• NUC: Lubricant, Personal

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2022-10-03
• Device Publish Date: 2022-09-23

On-Brand Devices [pjur INFINITY silicone-based ]

• 10827160115163: Silicone-based Personal Lubricant
• 10827160115255: Silicone-based Personal Lubricant