| Primary Device ID | 00714196316660 | 
| NIH Device Record Key | 49473cdf-f559-4b8d-a801-3a33c706ed1e | 
| Commercial Distribution Status | In Commercial Distribution | 
| Brand Name | ComfortFoam | 
| Version Model Number | 00316E | 
| Company DUNS | 883925562 | 
| Company Name | DERMARITE INDUSTRIES LLC | 
| Device Count | 10 | 
| 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 | false | 
| 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 | 00714196316660 [Primary] | 
| GS1 | 01714196316669 [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 | 
| 00714196448804 | 44880 | 
| 00714196446800 | 44680 | 
| 00714196444806 | 44480 | 
| 00714196443304 | 44330 | 
| 00714196442208 | 44220 | 
| 00714196316660 | 00316E | 
| 00714196315441 | 00315E | 
| 00714196044457 | 44450 | 
| 00714196390707 | 44880 | 
| 00714196390684 | 44680 | 
| 00714196390660 | 44480 | 
| 00714196390646 | 44450 | 
| 00714196390622 | 44330 | 
| 00714196390608 | 44220 | 
| 00714196390585 | 00316E | 
| 00714196390561 | 00315E | 
| Mark Image Registration | Serial | Company Trademark Application Date | 
|---|---|
|  COMFORTFOAM  97697428  not registered Live/Pending | Upper Echelon Products, LLC 2022-11-30 | 
|  COMFORTFOAM  86028966  4470976 Live/Registered | DermaRite Industries, LLC 2013-08-05 |