pjur AQUA Sachetcard 2021, 2ml USA

GUDID 00827160115029

Pjur Group Luxembourg SA

Sexual lubricant

• Primary Device ID: 00827160115029
• NIH Device Record Key: f2f9f483-b2af-4c07-a02a-ca8fce84a7b9
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: pjur AQUA Sachetcard 2021, 2ml USA
• Version Model Number: pjur AQUA Sachetcard 2021, 2ml 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: true
• 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	00827160115029 [Primary]

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: 2021-08-02
• Device Publish Date: 2021-07-23

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