| 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 |
| Phone | (480) 921-4948 |
| customerservice@vomaris.com | |
| Phone | (480) 921-4948 |
| customerservice@vomaris.com | |
| Phone | (480) 921-4948 |
| customerservice@vomaris.com | |
| Phone | (480) 921-4948 |
| customerservice@vomaris.com | |
| Phone | (480) 921-4948 |
| customerservice@vomaris.com | |
| Phone | (480) 921-4948 |
| customerservice@vomaris.com | |
| Phone | (480) 921-4948 |
| customerservice@vomaris.com | |
| Phone | (480) 921-4948 |
| customerservice@vomaris.com | |
| Phone | (480) 921-4948 |
| customerservice@vomaris.com | |
| Phone | (480) 921-4948 |
| customerservice@vomaris.com | |
| Phone | (480) 921-4948 |
| customerservice@vomaris.com |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00810198031140 [Primary] |
| FRO | Dressing, Wound, Drug |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2022-11-28 |
| Device Publish Date | 2022-11-18 |
| 00810198031140 | Procellera FLexEFit OTC, 2.5"x6.3" |
| 00810198030280 | Procellera FLexEFit Rx, 2.5"x6.3" |