| Primary Device ID | 00714196437709 |
| NIH Device Record Key | afd52f1a-e3cb-4f5c-b4be-54043873fa8b |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | ComfortFoam Border |
| Version Model Number | 43770 |
| Company DUNS | 883925562 |
| Company Name | DERMARITE INDUSTRIES LLC |
| Device Count | 5 |
| 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 | 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 | false |
| OTC Over-The-Counter | false |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00714196437709 [Primary] |
| GS1 | 01714196437708 [Unit of Use] |
| NAD | Dressing, Wound, Occlusive |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2020-09-09 |
| Device Publish Date | 2020-09-01 |
| 00714196437709 | 43770 |
| 00714196436801 | 43680 |
| 00714196434807 | 43480 |
| 00714196434128 | 43412 |
| 00714196433305 | 43330 |
| 00714196432506 | 43250 |
| 00714196432209 | 43220 |
| 00714196318664 | 00318E |
| 00714196317445 | 00317E |
| 00714196390882 | 43770 |
| 00714196390868 | 43680 |
| 00714196390844 | 43480 |
| 00714196390820 | 43412 |
| 00714196390806 | 43330 |
| 00714196390783 | 43250 |
| 00714196390769 | 43220 |
| 00714196390745 | 00318E |
| 00714196390721 | 00317E |