KerraLite Cool Border CWL1009

GUDID 05060077230675

CRAWFORD HEALTHCARE LIMITED

Wound hydrogel dressing, sterile

• Primary Device ID: 05060077230675
• NIH Device Record Key: 894e0c5b-5e92-41df-b756-1ee7a82f7b5a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: KerraLite Cool Border
• Version Model Number: 6x6in
• Catalog Number: CWL1009
• 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: +44 1565654920
• Email: andrew.jackson@acelity.com
• Phone: +44 1565654920
• Email: andrew.jackson@acelity.com
• Phone: +44 1565654920
• Email: andrew.jackson@acelity.com
• Phone: +44 1565654920
• Email: andrew.jackson@acelity.com
• Phone: +44 1565654920
• Email: andrew.jackson@acelity.com
• Phone: +44 1565654920
• Email: andrew.jackson@acelity.com
• Phone: +44 1565654920
• Email: andrew.jackson@acelity.com
• Phone: +44 1565654920
• Email: andrew.jackson@acelity.com
• Phone: +44 1565654920
• Email: andrew.jackson@acelity.com
• Phone: +44 1565654920
• Email: andrew.jackson@acelity.com
• Phone: +44 1565654920
• Email: andrew.jackson@acelity.com
• Phone: +44 1565654920
• Email: andrew.jackson@acelity.com
• Phone: +44 1565654920
• Email: andrew.jackson@acelity.com
• Phone: +44 1565654920
• Email: andrew.jackson@acelity.com

Device Dimensions

• Height: 6 Inch
• Length: 6 Inch
• Height: 6 Inch
• Length: 6 Inch
• Height: 6 Inch
• Length: 6 Inch
• Height: 6 Inch
• Length: 6 Inch
• Height: 6 Inch
• Length: 6 Inch
• Height: 6 Inch
• Length: 6 Inch
• Height: 6 Inch
• Length: 6 Inch
• Height: 6 Inch
• Length: 6 Inch
• Height: 6 Inch
• Length: 6 Inch
• Height: 6 Inch
• Length: 6 Inch
• Height: 6 Inch
• Length: 6 Inch
• Height: 6 Inch
• Length: 6 Inch
• Height: 6 Inch
• Length: 6 Inch
• Height: 6 Inch

Operating and Storage Conditions

• 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 Identifiers

Device Issuing Agency	Device ID
GS1	05060077230675 [Package]; Contains: 05060077231283; Package: Carton [5 Units]; In Commercial Distribution
GS1	05060077231283 [Primary]
GS1	05060077232754 [Package]; Package: Shipper [32 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 Border]

• 05060077230675: 6x6in
• 05060077230668: Soothing, debriding and moisture-balancing dressing.
• 05060077230651: 3x3in