| Primary Device ID | 00810198031478 |
| NIH Device Record Key | dcf4c2d8-9873-412c-b1f0-19104098c928 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | PowerHeal Kit |
| Version Model Number | 4"x4", 6"x6", 2.3"x3.5" (3-layer) & Energel |
| Catalog Number | PFK-C246-05 |
| 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 | true |
| 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 | true |
| 00810198031515 | PowerHeal Kit, 4"x4" Single Layer, Energel & Tegaderm |
| 00810198031508 | PowerHeal Kit, 2"x2" Single Layer, Energel & Tegaderm |
| 00810198031492 | PowerHeal, 4"x4" Single Layer, & Energel |
| 00810198031485 | PowerHeal Kit, 2"x2" Single Layer & Energel |
| 00810198031478 | PowerHeal Combo Kit, 4"x4", 6"x6", 2.3"x3.5" (3-layer clear adhesive) & Energel |
| 00810198031461 | PowerHeal Kit, 2.3"x 3.5" 3-layer clear adhesive & Energel |
| 00810198031454 | PowerHeal Kit, 6"x6" 3-layer & Energel |
| 00810198031447 | PowerHeal Kit, 4"x4" 3-layer clear adhesive & Energel |