FDA.reportPublic FDA data

CARDINAL HEALTH

Primary DI
10195594457297
Brand
CARDINAL HEALTH
Company
Cardinal Health 200, LLC
Model
WNDHF5494C
Catalog number
WNDHF5494C
Device description
KIT, COLO ILEO 134, 7146
Published
2021-12-27
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Product Codes#

Code, Name table
CodeName
LRRFirst Aid Kit with drug

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LRRFirst Aid Kit With DrugUnknownN

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
50195594457295PackageGS130In Commercial Distribution
10195594457297PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
5019559445729550195594457295
1019559445729710195594457297

GMDN Terms#

Term, Definition table
TermDefinition
General surgical procedure kit, non-medicated, single-useA typically non-dedicated collection of various surgical instruments, sometimes with dressings and/or other materials, but that does not contain pharmaceuticals, intended to be used during: 1) open abdominal surgery; 2) a range of open surgical procedures across multiple clinical specialties (non-dedicated); 3) non-orthopaedic trauma surgery; 4) minor dermatological surgery; or 5) cosmetic surgery below the head. As a kit that includes procedural devices, it is neither dedicated to surgical scrubbing, surgical patient preparation, nor anaesthesia, and is not a dedicated biopsy kit. This is a single-use device.

Regulatory Flags#

DUNS number
961027315
Device count
1
Premarket exempt
true
Kit
true
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10192253004243Monoject31143699311436992026-08-03
10192253004250Monoject31143798311437982026-08-03
10192253004304Monoject31300878313008782026-08-03
20192253050353Vistec659165912023-05-24
10192253004458Monoject85121851212026-07-31
10192253004465Monoject8513018513012026-07-31
10192253004472Monoject85131851312026-07-31
10192253004915Monoject890689062026-07-31
10192253005066Monoject89671896712026-07-31
10192253005295Monoject8990Y8990Y2026-07-31
10192253005516Monoject8535Y8535Y2026-07-31
10192253005622Monoject8970Y8970Y2026-07-31
10197106933145CARDINAL HEALTHPV42CJTMZPV42CJTMZ2026-07-31
10197106950012CARDINAL HEALTHSAN56IPIDFSAN56IPIDF2026-07-31
10198956027596CARDINAL HEALTHSCV73CAHFHSCV73CAHFH2026-07-31
10198956327603CARDINAL HEALTH26-8545D26-8545D2026-07-31
10198956342217CARDINAL HEALTHPB15LHFCLPB15LHFCL2026-07-31
10198956352315CARDINAL HEALTHPW45KFMSAPW45KFMSA2026-07-31
10198956353961CARDINAL HEALTHSNEHBNEECDSNEHBNEECD2026-07-31
10198956364998CARDINAL HEALTHSBADHHMCFDSBADHHMCFD2026-07-31

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00850070635172FIRST AID REFILL KITNar Medical Depot, LLCLRR2026-07-24
00850070635189FIRST AID KIT CABINETNar Medical Depot, LLCLRR2026-07-24
00850070635196FIRST AID KITNar Medical Depot, LLCLRR2026-07-24
M689PBEFAK010Point Blank Enterprises Employee FAK - Private LabelSafeguard US Operating, LLCLRR2026-07-09
00850070635165KIT, FIRST AIDNar Medical Depot, LLCLRR2026-06-25
00860014697326RiskWise Health KitsRiskWise Supplies LLCLRR2026-06-15
00766588260112Class A 21 - Grab-N-Go Large - Red Velcro BagCertified Safety Manufacturing, Inc.LRR2026-06-04
00888277719081RexallMEDLINE INDUSTRIES, INC.LRR2026-06-03
00842209138890NARNORTH AMERICAN RESCUE, LLCLRR2026-05-27
00842209138906NARNORTH AMERICAN RESCUE, LLCLRR2026-05-27
00842209138913NARNORTH AMERICAN RESCUE, LLCLRR2026-05-27
00842209138920NARNORTH AMERICAN RESCUE, LLCLRR2026-05-27
00842209138944NARNORTH AMERICAN RESCUE, LLCLRR2026-05-27
00842209138951NARNORTH AMERICAN RESCUE, LLCLRR2026-05-27
00050428000021CVS Health WOONSOCKET PRESCRIPTION CENTER, INCORPORATEDLRR2026-05-19
00860014697333RiskWise Health KitsRiskWise Supplies LLCLRR2026-05-18
00092265917841First Aid OnlyAcme United CorporationLRR2026-04-23
00020424221249BE SMART GET PREPAREDTOTAL RESOURCES INTERNATIONAL INC.LRR2026-04-21
00713733293129MEIJERMEIJER, INC.LRR2026-04-20
00760236195603MeijerMEIJER, INC.LRR2026-04-20
00666365119704NanukNanuk Gear Protection USA Inc.LRR2026-04-16
10850015055826Trauma KitULINE, INC.LRR2026-04-06
20020424226811BE SMART GET PREPAREDTOTAL RESOURCES INTERNATIONAL INC.LRR2026-04-02
00020424010157BE SMART GET PREPAREDTOTAL RESOURCES INTERNATIONAL INC.LRR2026-03-31
00020424016432ESSENTIALSTOTAL RESOURCES INTERNATIONAL INC.LRR2026-03-27
00017276241334Bluey First Aid KitAso LLCLRR2026-03-03
00197344173627CURADMEDLINE INDUSTRIES, INC.LRR2026-01-23
00020424060770BE SMART GET PREPAREDTOTAL RESOURCES INTERNATIONAL INC.LRR2025-11-21
00017276240931up&upTARGET CORPORATIONLRR2025-11-03
M68924105050Poolside Medical Rescue RefillSafeguard US Operating, LLCLRR2025-10-14