Amerigel A2001

GUDID 00361470101414

Amerigel Hydrogel Wound Dressing

Amerx Health Care Corp.

Wound hydrogel dressing, non-antimicrobial

• Primary Device ID: 00361470101414
• NIH Device Record Key: 410e22c0-cb54-4188-b667-06c74746c191
• Commercial Distribution Discontinuation: 2023-10-31
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Amerigel
• Version Model Number: 1
• Catalog Number: A2001
• Company DUNS: 836425694
• Company Name: Amerx Health Care Corp.
• Device Count: 1
• DM Exempt: true
• 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: true
• Single Use: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• 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	00361470101414 [Primary]

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: 2023-10-06
• Device Publish Date: 2023-09-28