DermaBlue + Foam Healogics by DermaRite

GUDID 00714196941145

DERMARITE INDUSTRIES LLC

Exudate-absorbent dressing, non-gel, antimicrobial

• Primary Device ID: 00714196941145
• NIH Device Record Key: 70e18e37-7fb2-498b-9845-372bafc80f3d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: DermaBlue + Foam Healogics by DermaRite
• Version Model Number: 94114
• 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	00714196941145 [Primary]
GS1	01714196941144 [Unit of Use]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K060832

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 [DermaBlue + Foam Healogics by DermaRite]

• 00714196941145: 94114
• 00714196941114: 94111