Procellera FLexEFit VFR-2563

GUDID 00810198030280

Procellera FLexEFit Rx, 2.5"x6.3"

Vomaris Wound Care, Inc.

Bioelectric wound dressing

• Primary Device ID: 00810198030280
• NIH Device Record Key: d0fcc471-28ab-453e-84aa-73d04ae047b1
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Procellera FLexEFit
• Version Model Number: 2.5"x6.3"
• Catalog Number: VFR-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	00810198030204 [Primary]
GS1	00810198030280 [Package]; Contains: 00810198030204; Package: Box [5 Units]; In Commercial Distribution
GS1	00810198030297 [Package]; Contains: 00810198030204; Package: Box [10 Units]; In Commercial Distribution

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"