| Primary Device ID | 05060077230668 |
| NIH Device Record Key | 20ceea7c-3fcc-40ad-904b-77055bf194d4 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | KerraLite Cool Border |
| Version Model Number | 4x4in |
| Catalog Number | CWL1008 |
| Company DUNS | 543740310 |
| Company Name | CRAWFORD HEALTHCARE LIMITED |
| Device Count | 1 |
| 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 | false |
| RX Perscription | false |
| OTC Over-The-Counter | false |
| Height | 4 Inch |
| Length | 4 Inch |
| Height | 4 Inch |
| Length | 4 Inch |
| Height | 4 Inch |
| Length | 4 Inch |
| Height | 4 Inch |
| Length | 4 Inch |
| Height | 4 Inch |
| Length | 4 Inch |
| Height | 4 Inch |
| Length | 4 Inch |
| Height | 4 Inch |
| Length | 4 Inch |
| Height | 4 Inch |
| Length | 4 Inch |
| Height | 4 Inch |
| Length | 4 Inch |
| Height | 4 Inch |
| Length | 4 Inch |
| Height | 4 Inch |
| Length | 4 Inch |
| Height | 4 Inch |
| Length | 4 Inch |
| Height | 4 Inch |
| Length | 4 Inch |
| Height | 4 Inch |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Special Storage Condition, Specify | Between 0 and 0 *Store out of direct sunlight |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Special Storage Condition, Specify | Between 0 and 0 *Store out of direct sunlight |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Special Storage Condition, Specify | Between 0 and 0 *Store out of direct sunlight |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Special Storage Condition, Specify | Between 0 and 0 *Store out of direct sunlight |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Special Storage Condition, Specify | Between 0 and 0 *Store out of direct sunlight |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Special Storage Condition, Specify | Between 0 and 0 *Store out of direct sunlight |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Special Storage Condition, Specify | Between 0 and 0 *Store out of direct sunlight |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Special Storage Condition, Specify | Between 0 and 0 *Store out of direct sunlight |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Special Storage Condition, Specify | Between 0 and 0 *Store out of direct sunlight |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Special Storage Condition, Specify | Between 0 and 0 *Store out of direct sunlight |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Special Storage Condition, Specify | Between 0 and 0 *Store out of direct sunlight |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Special Storage Condition, Specify | Between 0 and 0 *Store out of direct sunlight |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Special Storage Condition, Specify | Between 0 and 0 *Store out of direct sunlight |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 05060077230668 [Package] Contains: 05060077231276 Package: Carton [5 Units] In Commercial Distribution |
| GS1 | 05060077231276 [Primary] |
| GS1 | 05060077232747 [Package] Package: Shipper [52 Units] In Commercial Distribution |
| GS1 | 05060077233805 [Package] Contains: 05060077231276 Package: Shipper [550 Units] In Commercial Distribution |
| 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 | 2019-10-09 |
| Device Publish Date | 2019-10-01 |
| 05060077230675 | 6x6in |
| 05060077230668 | Soothing, debriding and moisture-balancing dressing. |
| 05060077230651 | 3x3in |