Drawtex Hydroconductive Wound Dressing with LevaFiber Edema Wrap 00352

GUDID 00851383003528

Drawtex Hydroconductive Wound Dressing with LevaFiber Edema Wrap (1 bx of 10 dressings) is a nonmedicated dressing made up of natural and synthetic fibers: viscose, cotton and polyester. It is for the management of acute wounds, including complex surgical wounds and burns (first and second degree) and management of chronic wounds including leg ulcers, diabetic foot ulcers and pressure ulcers (stages II - IV).

URGO MEDICAL NORTH AMERICA, LLC

Wound-nonadherent dressing, absorbent, sterile Wound-nonadherent dressing, absorbent, non-antimicrobial Wound-nonadherent dressing, absorbent, non-antimicrobial Wound-nonadherent dressing, absorbent, non-antimicrobial Wound-nonadherent dressing, absorbent, non-antimicrobial Wound-nonadherent dressing, absorbent, non-antimicrobial Wound-nonadherent dressing, absorbent, non-antimicrobial Wound-nonadherent dressing, absorbent, non-antimicrobial Wound-nonadherent dressing, absorbent, non-antimicrobial Wound-nonadherent dressing, absorbent, non-antimicrobial Wound-nonadherent dressing, absorbent, non-antimicrobial Wound-nonadherent dressing, absorbent, non-antimicrobial Wound-nonadherent dressing, absorbent, non-antimicrobial Wound-nonadherent dressing, absorbent, non-antimicrobial Wound-nonadherent dressing, absorbent, non-antimicrobial Wound-nonadherent dressing, absorbent, non-antimicrobial Wound-nonadherent dressing, absorbent, non-antimicrobial

Primary Device ID	00851383003528
NIH Device Record Key	6dd4289e-272f-4684-b040-533e4c94e724
Commercial Distribution Status	In Commercial Distribution
Brand Name	Drawtex Hydroconductive Wound Dressing with LevaFiber Edema Wrap
Version Model Number	00352
Catalog Number	00352
Company DUNS	052758618
Company Name	URGO MEDICAL NORTH AMERICA, LLC
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	1-855-888-8273
Email	info@us.urgo.com
Phone	1-855-888-8273
Email	info@us.urgo.com
Phone	1-855-888-8273
Email	info@us.urgo.com
Phone	1-855-888-8273
Email	info@us.urgo.com
Phone	1-855-888-8273
Email	info@us.urgo.com
Phone	1-855-888-8273
Email	info@us.urgo.com
Phone	1-855-888-8273
Email	info@us.urgo.com
Phone	1-855-888-8273
Email	info@us.urgo.com
Phone	1-855-888-8273
Email	info@us.urgo.com
Phone	1-855-888-8273
Email	info@us.urgo.com
Phone	1-855-888-8273
Email	info@us.urgo.com
Phone	1-855-888-8273
Email	info@us.urgo.com
Phone	1-855-888-8273
Email	info@us.urgo.com
Phone	1-855-888-8273
Email	info@us.urgo.com
Phone	1-855-888-8273
Email	info@us.urgo.com
Phone	1-855-888-8273
Email	info@us.urgo.com
Phone	1-855-888-8273
Email	info@us.urgo.com

Device Dimensions

Height	39 Inch
Width	4 Inch
Height	39 Inch
Width	4 Inch
Height	39 Inch
Width	4 Inch
Height	39 Inch
Width	4 Inch
Height	39 Inch
Width	4 Inch
Height	39 Inch
Width	4 Inch
Height	39 Inch
Width	4 Inch
Height	39 Inch
Width	4 Inch
Height	39 Inch
Width	4 Inch
Height	39 Inch
Width	4 Inch
Height	39 Inch
Width	4 Inch
Height	39 Inch
Width	4 Inch
Height	39 Inch
Width	4 Inch
Height	39 Inch
Width	4 Inch
Height	39 Inch
Width	4 Inch
Height	39 Inch
Width	4 Inch
Height	39 Inch

Operating and Storage Conditions

Storage Environment Temperature	Between 46 Degrees Fahrenheit and 59 Degrees Fahrenheit
Storage Environment Humidity	Between 0 Percent (%) Relative Humidity and 40 Percent (%) Relative Humidity
Storage Environment Temperature	Between 46 Degrees Fahrenheit and 59 Degrees Fahrenheit
Storage Environment Humidity	Between 0 Percent (%) Relative Humidity and 40 Percent (%) Relative Humidity
Storage Environment Temperature	Between 46 Degrees Fahrenheit and 59 Degrees Fahrenheit
Storage Environment Humidity	Between 0 Percent (%) Relative Humidity and 40 Percent (%) Relative Humidity
Storage Environment Temperature	Between 46 Degrees Fahrenheit and 59 Degrees Fahrenheit
Storage Environment Humidity	Between 0 Percent (%) Relative Humidity and 40 Percent (%) Relative Humidity
Storage Environment Temperature	Between 46 Degrees Fahrenheit and 59 Degrees Fahrenheit
Storage Environment Humidity	Between 0 Percent (%) Relative Humidity and 40 Percent (%) Relative Humidity
Storage Environment Temperature	Between 46 Degrees Fahrenheit and 59 Degrees Fahrenheit
Storage Environment Humidity	Between 0 Percent (%) Relative Humidity and 40 Percent (%) Relative Humidity
Storage Environment Temperature	Between 46 Degrees Fahrenheit and 59 Degrees Fahrenheit
Storage Environment Humidity	Between 0 Percent (%) Relative Humidity and 40 Percent (%) Relative Humidity
Storage Environment Temperature	Between 46 Degrees Fahrenheit and 59 Degrees Fahrenheit
Storage Environment Humidity	Between 0 Percent (%) Relative Humidity and 40 Percent (%) Relative Humidity
Storage Environment Temperature	Between 46 Degrees Fahrenheit and 59 Degrees Fahrenheit
Storage Environment Humidity	Between 0 Percent (%) Relative Humidity and 40 Percent (%) Relative Humidity
Storage Environment Temperature	Between 46 Degrees Fahrenheit and 59 Degrees Fahrenheit
Storage Environment Humidity	Between 0 Percent (%) Relative Humidity and 40 Percent (%) Relative Humidity
Storage Environment Temperature	Between 46 Degrees Fahrenheit and 59 Degrees Fahrenheit
Storage Environment Humidity	Between 0 Percent (%) Relative Humidity and 40 Percent (%) Relative Humidity
Storage Environment Temperature	Between 46 Degrees Fahrenheit and 59 Degrees Fahrenheit
Storage Environment Humidity	Between 0 Percent (%) Relative Humidity and 40 Percent (%) Relative Humidity
Storage Environment Temperature	Between 46 Degrees Fahrenheit and 59 Degrees Fahrenheit
Storage Environment Humidity	Between 0 Percent (%) Relative Humidity and 40 Percent (%) Relative Humidity
Storage Environment Temperature	Between 46 Degrees Fahrenheit and 59 Degrees Fahrenheit
Storage Environment Humidity	Between 0 Percent (%) Relative Humidity and 40 Percent (%) Relative Humidity
Storage Environment Temperature	Between 46 Degrees Fahrenheit and 59 Degrees Fahrenheit
Storage Environment Humidity	Between 0 Percent (%) Relative Humidity and 40 Percent (%) Relative Humidity
Storage Environment Temperature	Between 46 Degrees Fahrenheit and 59 Degrees Fahrenheit
Storage Environment Humidity	Between 0 Percent (%) Relative Humidity and 40 Percent (%) Relative Humidity
Storage Environment Temperature	Between 46 Degrees Fahrenheit and 59 Degrees Fahrenheit

Device Identifiers

Device Issuing Agency	Device ID
GS1	00851383003528 [Primary]
GS1	10851383003525 [Package] Package: Carton [10 Units] In Commercial Distribution
GS1	20851383003522 [Package] Contains: 10851383003525 Package: Case [10 Units] In Commercial Distribution

FDA Product Code

NAC	Dressing, Wound, Hydrophilic

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	2020-02-11
Device Publish Date	2020-02-03

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