FDA.reportPublic FDA data

Wound CareKit

Primary DI
00850050570011
Brand
Wound CareKit
Company
Mirodx, LLC
Model
MDXWC02
Catalog number
MDXWC021
Device description
Wound CareKit inclusive of the components needed for a wound dressing change.
Published
2023-02-23
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
MCYWound Dressing Kit

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MCYWound Dressing KitGeneral Hospital2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850050570011PackageGS115In Commercial Distribution
00860009502901PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850050570011008500505700118500505700110850050570011
00860009502901008600095029018600095029010860009502901

GMDN Terms#

Term, Definition table
TermDefinition
Wound dressing kit, non-medicatedA 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.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
1-888-656-3444help@mirodx.com

Regulatory Flags#

DUNS number
118764449
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
true
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850050570097Wound CareKitMDXWC06MDXWC0612023-11-06
00850050570103Wound CareKitMDXWC07MDXWC0712023-11-06
00850050570110Wound CareKit MDXWC03MDXWC0332023-11-06
00860009502987Wound CareKit MDXWC02MDXWC0222023-05-22
00860009502963Wound CareKit MDXWC01MDXWC0122023-02-24
00860009502970Wound CareKit MDXWC01MDXWC0132023-02-24
00860009502918Wound CareKit MDXWC01MDXWC0112023-02-22
00860009502932Wound CareKit MDXWC04MDXWC041 2023-02-22
00860009502956Wound CareKit MDXWC05MDXWC0512023-02-22
00860009502994Wound CareKit MDXWC02MDXWC0232023-02-28
00860009502901Wound CareKit MDXWC02MDXWC0212023-02-23
00860009502925Wound CareKit MDXWC03MDXWC0322023-02-22

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10198459428623MEDLINE INDUSTRIES, INC.MEDLINE INDUSTRIES, INC.MCY2025-07-21
10198459433474MEDLINE INDUSTRIES, INC.MEDLINE INDUSTRIES, INC.MCY2025-07-21
10198459171789Medline Industries, Inc.MEDLINE INDUSTRIES, INC.MCY2024-11-24
10653160381518MEDLINEMEDLINE INDUSTRIES, INC.MCY2024-10-28
10198459057939Medline Industries, Inc.MEDLINE INDUSTRIES, INC.MCY2024-10-20
10195327657833Medline Industries, Inc.MEDLINE INDUSTRIES, INC.MCY2024-07-29
10195327667924Medline Industries, Inc.MEDLINE INDUSTRIES, INC.MCY2024-07-29
10198459053849Medline Industries, Inc.MEDLINE INDUSTRIES, INC.MCY2024-06-30
10195327559182Medline Industries, Inc.MEDLINE INDUSTRIES, INC.MCY2023-12-21
10193489360479Medline Industries, Inc.MEDLINE INDUSTRIES, INC.MCY2023-07-29
10193489417005Medline Industries, Inc.MEDLINE INDUSTRIES, INC.MCY2023-07-29
10193489417043Medline Industries, Inc.MEDLINE INDUSTRIES, INC.MCY2023-07-29
10195327421298Medline Industries, Inc.MEDLINE INDUSTRIES, INC.MCY2023-07-29
10195327297725Medline Industries, Inc.MEDLINE INDUSTRIES, INC.MCY2023-06-13
10193489398335Medline Industries, Inc.MEDLINE INDUSTRIES, INC.MCY2023-06-08
10193489398427Medline Industries, Inc.MEDLINE INDUSTRIES, INC.MCY2023-06-08
10193489399820Medline Industries, Inc.MEDLINE INDUSTRIES, INC.MCY2023-06-08
10193489399929Medline Industries, Inc.MEDLINE INDUSTRIES, INC.MCY2023-06-08
10193489411560Medline Industries, Inc.MEDLINE INDUSTRIES, INC.MCY2023-06-08
10193489416954Medline Industries, Inc.MEDLINE INDUSTRIES, INC.MCY2023-06-08
10193489418286Medline Industries, Inc.MEDLINE INDUSTRIES, INC.MCY2023-06-08
10193489418385Medline Industries, Inc.MEDLINE INDUSTRIES, INC.MCY2023-06-08
10193489418392Medline Industries, Inc.MEDLINE INDUSTRIES, INC.MCY2023-06-08
10193489418408Medline Industries, Inc.MEDLINE INDUSTRIES, INC.MCY2023-06-08
10193489420982Medline Industries, Inc.MEDLINE INDUSTRIES, INC.MCY2023-06-08
10193489421088Medline Industries, Inc.MEDLINE INDUSTRIES, INC.MCY2023-06-08
10193489421606Medline Industries, Inc.MEDLINE INDUSTRIES, INC.MCY2023-06-08
10193489423600Medline Industries, Inc.MEDLINE INDUSTRIES, INC.MCY2023-06-08
10193489432121Medline Industries, Inc.MEDLINE INDUSTRIES, INC.MCY2023-06-08
10193489432138Medline Industries, Inc.MEDLINE INDUSTRIES, INC.MCY2023-06-08