ComfortFoam/Ag

GUDID 00714196496607

DERMARITE INDUSTRIES LLC

Exudate-absorbent dressing, non-gel, antimicrobial

• Primary Device ID: 00714196496607
• NIH Device Record Key: 5f0538bc-9bb4-4b84-941c-fa3ee5a09f34
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ComfortFoam/Ag
• Version Model Number: 49660
• Company DUNS: 883925562
• Company Name: DERMARITE INDUSTRIES LLC
• 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: 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	00714196496607 [Primary]
GS1	01714196496606 [Unit of Use]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K160022

FDA Product Code

• FRO: Dressing, Wound, Drug

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 [ComfortFoam/Ag]

• 00714196496607: 49660
• 00714196494504: 49450
• 00714196492203: 49220
• 00714196391063: 49660
• 00714196391049: 49450
• 00714196391025: 49220