Wound CareKit

Basic Information

• Brand Name: Wound CareKit
• Primary DI: 00860009502901
• Version / Model: MDXWC02
• Catalog Number: MDXWC021
• Company Name: Mirodx, LLC
• Labeler DUNS: 118764449
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2023-02-23
• Public Version: 1
• Public Version Date: 2023-03-03
• Public Version Status: New
• Public Device Record Key: 65e3a262-8b83-42ab-a7c7-00002c50d69c

Device Description

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

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: Yes
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: Yes
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: Yes
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
MCY	Wound Dressing Kit	General Hospital	880.5075	2

GMDN Terms

Code	Name	Definition	Implantable	Status
62744	Wound dressing kit, non-medicated	A collection of instruments and dressings intended to be used to dress a wound. Items typically include scissors, forceps, gauze, and cotton-tip applicators; it does not contain a pharmaceutical. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	00850050570011	GS1	Bundle	15	In Commercial Distribution
Primary	00860009502901	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]