AquaDerm

GUDID 00714196322227

DERMARITE INDUSTRIES LLC

Wound hydrogel dressing, non-antimicrobial

• Primary Device ID: 00714196322227
• NIH Device Record Key: d9d5c24c-56f4-481c-986a-75d4bf8a154b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: AquaDerm
• Version Model Number: 00322E
• Company DUNS: 883925562
• Company Name: DERMARITE INDUSTRIES LLC
• Device Count: 10
• DM Exempt: false
• Pre-market Exempt: true
• 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: true
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00714196322227 [Primary]
GS1	01714196322226 [Unit of Use]

FDA Product Code

• NAE: Dressing, Wound, Hydrogel Without Drug And/Or Biologic

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2020-09-09
• Device Publish Date: 2020-09-01

On-Brand Devices [AquaDerm]

• 00714196324443: 00324E
• 00714196322227: 00322E
• 00714196390042: 00324E
• 00714196390028: 00322E