Luxamend

GUDID 10369489522067

Journey Medical Corporation

Dry skin moisture barrier dressing Dry skin moisture barrier dressing Dry skin moisture barrier dressing Dry skin moisture barrier dressing Dry skin moisture barrier dressing Dry skin moisture barrier dressing Dry skin moisture barrier dressing Dry skin moisture barrier dressing Dry skin moisture barrier dressing Dry skin moisture barrier dressing Dry skin moisture barrier dressing Dry skin moisture barrier dressing Dry skin moisture barrier dressing Dry skin moisture barrier dressing Dry skin moisture barrier dressing Dry skin moisture barrier dressing Dry skin moisture barrier dressing

• Primary Device ID: 10369489522067
• NIH Device Record Key: 02e3dde8-b83c-4960-8fea-e3e858d8d66c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Luxamend
• Version Model Number: 1
• Company DUNS: 079640860
• Company Name: Journey Medical Corporation
• Device Count: 10
• 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: false
• 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	00369489522060 [Primary]
GS1	10369489522067 [Unit of Use]

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