pjur Woman Aqua

GUDID 40827160112125

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 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: 40827160112125
• NIH Device Record Key: 3285e318-4fbd-4dc2-af95-50180d63ac4b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: pjur Woman Aqua
• Version Model Number: pjur Woman Aqua 100 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	00827160112127 [Primary]
GS1	10827160112124 [Package]; Contains: 00827160112127; Package: pack [12 Units]; In Commercial Distribution
GS1	40827160112125 [Package]; Contains: 10827160112124; Package: case [12 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: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2018-08-09
• Device Publish Date: 2017-01-25

Devices Manufactured by Pjur Group Luxembourg SA

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• 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
• 10827160115439 - pjur AQUA Natural: 2022-07-21 Water-based Personal Lubricant
• 10827160115187 - pjur AQUA Aloe: 2022-03-30 Water-based Personal Lubricant
• 10827160114999 - pjur med HYDRO glide: 2021-10-18 Water-based Personal Lubricant