| Primary Device ID | 04054596952447 |
| NIH Device Record Key | 61d47605-da7e-4fa7-843e-c18d0d9caad4 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | 3M™ Kerralite Cool™ |
| Version Model Number | CWL1008-B550 |
| Catalog Number | CWL1008-B550 |
| Company DUNS | 315731711 |
| Company Name | 3M Deutschland GmbH |
| Device Count | 550 |
| 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 | true |
| Expiration Date | true |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | false |
| OTC Over-The-Counter | false |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 04054596952447 [Unit of Use] |
| GS1 | 04054596952485 [Primary] |
| NAE | Dressing, wound, hydrogel without drug and/or biologic |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2024-03-05 |
| Device Publish Date | 2024-02-26 |
| 04054596952515 | 3M™ Kerralite Cool™ Border Moisture-Balancing Hydrogel Adhesive Dressing, CWL1009, 6 in x 6 |
| 04054596952461 | 3M™ Kerralite Cool™ Border Moisture-Balancing Hydrogel Adhesive Dressing, CWL1008, 4 in x 4 |
| 04054596952430 | 3M™ Kerralite Cool™ Border Moisture-Balancing Hydrogel Adhesive Dressing, CWL1007, 3 in x 3 |
| 04054596952409 | 3M™ Kerralite Cool™ Moisture-Balancing Hydrogel Non-Adhesive Dressing, CWL1006, 5 in x 7 in, |
| 04054596952379 | 3M™ Kerralite Cool™ Moisture-Balancing Hydrogel Non-Adhesive Dressing, CWL1005, 5 in x 3.5 i |
| 04054596952348 | 3M™ Kerralite Cool™ Moisture-Balancing Hydrogel Non-Adhesive Dressing, CWL1004, 2 in x 2 in, |
| 04054596952447 | 3M™ Kerralite Cool™ Border Moisture-Balancing Hydrogel Adhesive Dressing, CWL1008-B550, 4 in |