ComfiTel

GUDID 00714196564702

DERMARITE INDUSTRIES LLC

Synthetic polymer semi-permeable film dressing, wound-nonadherent Synthetic polymer semi-permeable film dressing, wound-nonadherent Synthetic polymer semi-permeable film dressing, wound-nonadherent Synthetic polymer semi-permeable film dressing, wound-nonadherent Synthetic polymer semi-permeable film dressing, wound-nonadherent Synthetic polymer semi-permeable film dressing, wound-nonadherent Synthetic polymer semi-permeable film dressing, wound-nonadherent Synthetic polymer semi-permeable film dressing, wound-nonadherent Synthetic polymer semi-permeable film dressing, wound-nonadherent Synthetic polymer semi-permeable film dressing, wound-nonadherent Synthetic polymer semi-permeable film dressing, wound-nonadherent Synthetic polymer semi-permeable film dressing, wound-nonadherent Synthetic polymer semi-permeable film dressing, wound-nonadherent

• Primary Device ID: 00714196564702
• NIH Device Record Key: b7833dfa-5c0c-4ad8-bf9a-9c578d2870ca
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ComfiTel
• Version Model Number: 56470
• 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: false
• 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	00714196564702 [Primary]
GS1	01714196564701 [Unit of Use]

FDA Product Code

• NAD: Dressing, Wound, Occlusive

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 [ComfiTel]

• 00714196564702: 56470
• 00714196563408: 56340
• 00714196562302: 56230
• 00714196390547: 56470
• 00714196390523: 56340
• 00714196390509: 56230