Luxamend

GUDID 00369489522145

Journey Medical Corporation

Dry skin moisture barrier dressing

• Primary Device ID: 00369489522145
• NIH Device Record Key: 8d128793-daf6-4c20-b1e0-6cfbaa3b646b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Luxamend
• Version Model Number: 1
• Company DUNS: 079640860
• Company Name: Journey Medical Corporation
• 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: false
• Lot Batch: true
• Serial Number: true
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00369489522145 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K122595

FDA Product Code

• FRO: Dressing, Wound, Drug

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: 2023-02-20
• Device Publish Date: 2023-02-10

On-Brand Devices [Luxamend]

• 00369489522145: 1
• 10369489522067: 1