KerraLite Cool Border CWL1008

GUDID 05060077230668

Soothing, debriding and moisture-balancing dressing.

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	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

Device Dimensions

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

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	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

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