pjur med HYDRO 14026-02

GUDID 10827160116276

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 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

• 10827160116276 - pjur med HYDRO: 2024-05-08Water-based Personal Lubricant
• 10827160116276 - pjur med HYDRO: 2024-05-08 Water-based Personal Lubricant
• 10827160116283 - pjur med SENSITIVE: 2024-05-08 Water-based Personal Lubricant
• 10827160116290 - pjur AQUA Natural: 2024-05-08 Water-based Personal Lubricant
• 10827160115255 - pjur INFINITY silicone-based: 2022-11-14 Silicone-based Personal Lubricant
• 10827160115262 - pjur INFINITY water-based: 2022-11-14 water-based Personal Lubricant
• 10827160115163 - pjur INFINITY silicone-based: 2022-10-03 Silicone-based Personal Lubricant
• 10827160115170 - pjur INFINITY water-based: 2022-10-03 water-based Personal Lubricant
• 10827160115422 - pjur AQUA Naked: 2022-07-21 Water-based Personal Lubricant