KerraLite Cool CWL1004
GUDID 05060077230590
CRAWFORD HEALTHCARE LIMITED
Wound hydrogel dressing, sterile Wound hydrogel dressing, non-antimicrobial Wound hydrogel dressing, non-antimicrobial Wound hydrogel dressing, non-antimicrobial Wound hydrogel dressing, non-antimicrobial Wound hydrogel dressing, non-antimicrobial Wound hydrogel dressing, non-antimicrobial Wound hydrogel dressing, non-antimicrobial Wound hydrogel dressing, non-antimicrobial Wound hydrogel dressing, non-antimicrobial Wound hydrogel dressing, non-antimicrobial Wound hydrogel dressing, non-antimicrobial Wound hydrogel dressing, non-antimicrobial Wound hydrogel dressing, non-antimicrobial| Primary Device ID | 05060077230590 |
| NIH Device Record Key | cec180c2-3d23-4d6b-ae9e-dc120a0edebe |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | KerraLite Cool |
| Version Model Number | 2.4 x 2.4in |
| Catalog Number | CWL1004 |
| 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 |
Customer Support Contacts
| Phone | +4401565654920 |
| andrew.jackson@acelity.com | |
| Phone | +4401565654920 |
| andrew.jackson@acelity.com | |
| Phone | +4401565654920 |
| andrew.jackson@acelity.com | |
| Phone | +4401565654920 |
| andrew.jackson@acelity.com | |
| Phone | +4401565654920 |
| andrew.jackson@acelity.com | |
| Phone | +4401565654920 |
| andrew.jackson@acelity.com | |
| Phone | +4401565654920 |
| andrew.jackson@acelity.com | |
| Phone | +4401565654920 |
| andrew.jackson@acelity.com | |
| Phone | +4401565654920 |
| andrew.jackson@acelity.com | |
| Phone | +4401565654920 |
| andrew.jackson@acelity.com | |
| Phone | +4401565654920 |
| andrew.jackson@acelity.com | |
| Phone | +4401565654920 |
| andrew.jackson@acelity.com | |
| Phone | +4401565654920 |
| andrew.jackson@acelity.com | |
| Phone | +4401565654920 |
| andrew.jackson@acelity.com |
Device Dimensions
| Height | 2.4 Inch |
| Length | 2.4 Inch |
| Height | 2.4 Inch |
| Length | 2.4 Inch |
| Height | 2.4 Inch |
| Length | 2.4 Inch |
| Height | 2.4 Inch |
| Length | 2.4 Inch |
| Height | 2.4 Inch |
| Length | 2.4 Inch |
| Height | 2.4 Inch |
| Length | 2.4 Inch |
| Height | 2.4 Inch |
| Length | 2.4 Inch |
| Height | 2.4 Inch |
| Length | 2.4 Inch |
| Height | 2.4 Inch |
| Length | 2.4 Inch |
| Height | 2.4 Inch |
| Length | 2.4 Inch |
| Height | 2.4 Inch |
| Length | 2.4 Inch |
| Height | 2.4 Inch |
| Length | 2.4 Inch |
| Height | 2.4 Inch |
| Length | 2.4 Inch |
| Height | 2.4 Inch |
Operating and Storage Conditions
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Store out of direct sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Store out of direct sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Store out of direct sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Store out of direct sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Store out of direct sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Store out of direct sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Store out of direct sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Store out of direct sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Store out of direct sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Store out of direct sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Store out of direct sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Store out of direct sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Store out of direct sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 77 Degrees Fahrenheit |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 05060077230590 [Package] Contains: 05060077231238 Package: Carton [5 Units] In Commercial Distribution |
| GS1 | 05060077231238 [Primary] |
| GS1 | 05060077232709 [Package] Package: Shipper [114 Units] In Commercial Distribution |
FDA Product Code
| NAE | Dressing, Wound, Hydrogel Without Drug And/Or Biologic |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | true |
Device Entry Metadata
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2019-10-09 |
| Device Publish Date | 2019-10-01 |
On-Brand Devices [KerraLite Cool]
| 05060077230613 | 7 x 5in |
| 05060077230606 | 5 x 3.5in |
| 05060077230590 | 2.4 x 2.4in |
Trademark Results [KerraLite Cool]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 KERRALITE COOL 79355796 not registered Live/Pending |
Systagenix Wound Management, Limited 2022-10-24 |
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