pjur AQUA Naked 13985-02

GUDID 10827160115422

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

• Primary Device ID: 10827160115422
• NIH Device Record Key: f00836f4-f9b1-4e1a-a681-0957bf434202
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: pjur AQUA Naked
• Version Model Number: pjur AQUA Naked, 100ml USA
• Catalog Number: 13985-02
• 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	00827160115425 [Primary]
GS1	10827160115422 [Package]; Contains: 00827160115425; Package: Pack [12 Units]; In Commercial Distribution
GS1	40827160115423 [Package]; 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: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2022-07-21
• Device Publish Date: 2022-07-13

Devices Manufactured by Pjur Group Luxembourg SA

• 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: 2022-07-21Water-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