Procellera FLexEFit VFC-2563

GUDID 00810198031140

Procellera FLexEFit OTC, 2.5"x6.3"

Vomaris Wound Care, Inc.

Bioelectric wound dressing Bioelectric wound dressing Bioelectric wound dressing Bioelectric wound dressing Bioelectric wound dressing Bioelectric wound dressing Bioelectric wound dressing Bioelectric wound dressing Bioelectric wound dressing Bioelectric wound dressing Bioelectric wound dressing

• Primary Device ID: 00810198031140
• NIH Device Record Key: 1c8b840e-f8a7-406f-982b-136a2392a681
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Procellera FLexEFit
• Version Model Number: 2.5"x6.3"
• Catalog Number: VFC-2563
• Company DUNS: 080126901
• Company Name: Vomaris Wound Care, Inc.
• Device Count: 1
• 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: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: (480) 921-4948
• Email: customerservice@vomaris.com
• Phone: (480) 921-4948
• Email: customerservice@vomaris.com
• Phone: (480) 921-4948
• Email: customerservice@vomaris.com
• Phone: (480) 921-4948
• Email: customerservice@vomaris.com
• Phone: (480) 921-4948
• Email: customerservice@vomaris.com
• Phone: (480) 921-4948
• Email: customerservice@vomaris.com
• Phone: (480) 921-4948
• Email: customerservice@vomaris.com
• Phone: (480) 921-4948
• Email: customerservice@vomaris.com
• Phone: (480) 921-4948
• Email: customerservice@vomaris.com
• Phone: (480) 921-4948
• Email: customerservice@vomaris.com
• Phone: (480) 921-4948
• Email: customerservice@vomaris.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00810198031140 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K180533

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: 2022-11-28
• Device Publish Date: 2022-11-18

On-Brand Devices [Procellera FLexEFit]

• 00810198031140: Procellera FLexEFit OTC, 2.5"x6.3"
• 00810198030280: Procellera FLexEFit Rx, 2.5"x6.3"