Wound CareKit MDXWC071

GUDID 00850050570103

Wound dressing kit, non-medicated

Primary Device ID	00850050570103
NIH Device Record Key	edaaae98-0fc9-48fc-8aa1-0a11286cc9dd
Commercial Distribution Status	In Commercial Distribution
Brand Name	Wound CareKit
Version Model Number	MDXWC07
Catalog Number	MDXWC071
Company DUNS	118764449
Company Name	Mirodx, 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	true
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	true
RX Perscription	true
OTC Over-The-Counter	false

Handling Environment Temperature	Between 15 Degrees Celsius and 25 Degrees Celsius
Handling Environment Temperature	Between 15 Degrees Celsius and 25 Degrees Celsius
Handling Environment Temperature	Between 15 Degrees Celsius and 25 Degrees Celsius
Handling Environment Temperature	Between 15 Degrees Celsius and 25 Degrees Celsius
Handling Environment Temperature	Between 15 Degrees Celsius and 25 Degrees Celsius
Handling Environment Temperature	Between 15 Degrees Celsius and 25 Degrees Celsius
Handling Environment Temperature	Between 15 Degrees Celsius and 25 Degrees Celsius
Handling Environment Temperature	Between 15 Degrees Celsius and 25 Degrees Celsius
Handling Environment Temperature	Between 15 Degrees Celsius and 25 Degrees Celsius
Handling Environment Temperature	Between 15 Degrees Celsius and 25 Degrees Celsius
Handling Environment Temperature	Between 15 Degrees Celsius and 25 Degrees Celsius
Handling Environment Temperature	Between 15 Degrees Celsius and 25 Degrees Celsius
Handling Environment Temperature	Between 15 Degrees Celsius and 25 Degrees Celsius
Handling Environment Temperature	Between 15 Degrees Celsius and 25 Degrees Celsius
Handling Environment Temperature	Between 15 Degrees Celsius and 25 Degrees Celsius
Handling Environment Temperature	Between 15 Degrees Celsius and 25 Degrees Celsius
Handling Environment Temperature	Between 15 Degrees Celsius and 25 Degrees Celsius

Device Issuing Agency	Device ID
GS1	00850050570103 [Primary]

MCY	Wound Dressing Kit

Steralize Prior To Use	false
Device Is Sterile	false

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00850050570103	Wound CareKit inclusive of the components needed for a wound dressing change.
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