pjur AQUA Natural 14028-02

GUDID 10827160116290

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	10827160116290
NIH Device Record Key	524744cd-569c-49c7-b721-34dcd4151523
Commercial Distribution Status	In Commercial Distribution
Brand Name	pjur AQUA Natural
Version Model Number	pjur AQUA Natural 2ml - USA
Catalog Number	14028-02
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	00827160116293 [Primary]
GS1	10827160116290 [Package] Contains: 00827160116293 Package: pack [50 Units] In Commercial Distribution
GS1	40827160116291 [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

On-Brand Devices [pjur AQUA Natural]

10827160115439	Water-based Personal Lubricant
10827160116290	Water-based Personal Lubricant