pjur Sampler Kit

GUDID 00827160113216

Pjur Group Luxembourg SA

Sexual lubricant

• Primary Device ID: 00827160113216
• NIH Device Record Key: c4783466-9d65-453f-aa8f-bf6f818e74e2
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: pjur Sampler Kit
• Version Model Number: pjur Sampler Kit 4 x 10ml - 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: true
• 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	00827160113216 [Primary]
GS1	10827160113213 [Package]; Package: kit [6 Units]; In Commercial Distribution
GS1	40827160113214 [Package]; Contains: 10827160113213; Package: case [15 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: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2019-01-04
• Device Publish Date: 2018-12-04

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• 10827160115170 - pjur INFINITY water-based: 2022-10-03 water-based Personal Lubricant