pjur med HYDRO 14026-02

GUDID 10827160116276

Water-based Personal Lubricant

Pjur Group Luxembourg SA

Sexual lubricant

• Primary Device ID: 10827160116276
• NIH Device Record Key: 6a73cd20-ac8c-4f19-860b-cb85aae6c420
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: pjur med HYDRO
• Version Model Number: pjur med HYDRO 2 ml - USA
• Catalog Number: 14026-02
• 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	00827160116279 [Primary]
GS1	10827160116276 [Package]; Contains: 00827160116279; Package: pack [50 Units]; In Commercial Distribution
GS1	40827160116277 [Package]; Package: case [20 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K200527

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: 2024-05-08
• Device Publish Date: 2024-04-30

Devices Manufactured by Pjur Group Luxembourg SA

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• 00827160116750 - pjur analyse me! Relaxing, 1,5 ml USA: 2025-04-24 personal lubricant, silicone-based
• 10827160116771 - pjur BACK DOOR Relaxing: 2025-04-24 Silicone-based Personal Lubricant
• 10827160116788 - pjur BACK DOOR Moisturizing: 2025-04-24 Water-based Personal Lubricant
• 00827160114350 - pjur analyse me! Moisturizing glide: 2025-04-18 Water-based Personal Lubricant Part of pjur Mini Collection - 4 X 10 ml USA Package DI 10827160114289
• 10827160116764 - pjur AQUA Naked: 2025-04-01 Water-based Personal Lubricant
• 00827160114367 - pjur WOMAN Nude: 2024-05-31 Water-based Personal Lubricant Mini-Collection USA
• 10827160116276 - pjur med HYDRO: 2024-05-08Water-based Personal Lubricant
• 10827160116276 - pjur med HYDRO: 2024-05-08 Water-based Personal Lubricant