FDA.reportPublic FDA data

CARDINAL HEALTH

Primary DI
10198956592223
Brand
CARDINAL HEALTH
Company
Cardinal Health 200, LLC
Model
03E5798F
Catalog number
03E5798F
Device description
CENTRAL LINE KIT GTR THAN 1 YR
Published
2026-10-12
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
OXQDressing change tray

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OXQDressing Change TrayGeneral Hospital1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
50198956592221PackageGS125In Commercial Distribution
10198956592223PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
5019895659222150198956592221
1019895659222310198956592223

GMDN Terms#

Term, Definition table
TermDefinition
General surgical procedure kit, medicatedA typically non-dedicated collection of various surgical instruments, sometimes with dressings and/or other materials, and that includes a pharmaceutical component, 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.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature00

Regulatory Flags#

DUNS number
961027315
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
true
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
10198956537798CARDINAL HEALTHSOP53TOWRGSOP53TOWRG2026-10-13
10198956539914CARDINAL HEALTHSOP48EX85ASOP48EX85A2026-10-13
10198956541658CARDINAL HEALTHSAN1DRPUNCSAN1DRPUNC2026-10-13
10198956545182CARDINAL HEALTHSOP53SLVLLSOP53SLVLL2026-10-13
10198956549050CARDINAL HEALTHSOP45THBMJSOP45THBMJ2026-10-13
10198956559516CARDINAL HEALTH08-0857C08-0857C2026-10-13
10198956562950CARDINAL HEALTHSBA43MPMADSBA43MPMAD2026-10-13
10198956563223CARDINAL HEALTHSOP42ARBTHSOP42ARBTH2026-10-13
10198956564237CARDINAL HEALTHSEY45BPPAESEY45BPPAE2026-10-13
10198956570740CARDINAL HEALTHSEN48ESSNASEN48ESSNA2026-10-13
10198956570993CARDINAL HEALTH34-2403F34-2403F2026-10-13
10198956573024CARDINAL HEALTHSMA54MGFMPSMA54MGFMP2026-10-13
10198956577084CARDINAL HEALTH08-0857D08-0857D2026-10-13
10198956578753CARDINAL HEALTH34-7753A34-7753A2026-10-13
10198956588721CARDINAL HEALTHSMA40DERWDSMA40DERWD2026-10-13
10198956589810CARDINAL HEALTHSBAOCRPS30SBAOCRPS302026-10-13
10198956592698CARDINAL HEALTHSAN53ANOV6SAN53ANOV62026-10-13
10198956593770CARDINAL HEALTHSOTOCURGR3SOTOCURGR32026-10-13
10198956595071CARDINAL HEALTH31-826AW31-826AW2026-10-13
10198956597891CARDINAL HEALTHSBA43RPUSESBA43RPUSE2026-10-13

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10653160393443CENTURIONCENTURION MEDICAL PRODUCTS CORPORATIONOXQ2026-10-08
10653160394075CENTURIONCENTURION MEDICAL PRODUCTS CORPORATIONOXQ2026-10-08
10653160394532MEDLINEMEDLINE INDUSTRIES, INC.OXQ2026-10-08
10653160394594MEDLINEMEDLINE INDUSTRIES, INC.OXQ2026-10-08
10653160394921MEDLINEMEDLINE INDUSTRIES, INC.OXQ2026-10-08
10653160395119MEDLINEMEDLINE INDUSTRIES, INC.OXQ2026-10-08
10653160395270MEDLINEMEDLINE INDUSTRIES, INC.OXQ2026-10-08
10653160393344CENTURIONCENTURION MEDICAL PRODUCTS CORPORATIONOXQ2026-10-07
10653160393818CENTURIONCENTURION MEDICAL PRODUCTS CORPORATIONOXQ2026-10-07
10653160393986MEDLINEMEDLINE INDUSTRIES, INC.OXQ2026-10-07
10653160394464CENTURIONCENTURION MEDICAL PRODUCTS CORPORATIONOXQ2026-10-07
10198956570979CARDINAL HEALTHCardinal Health 200, LLCOXQ2026-10-06
10198956586239CARDINAL HEALTHCardinal Health 200, LLCOXQ2026-10-06
10198956588097CARDINAL HEALTHCardinal Health 200, LLCOXQ2026-10-06
10198956589766CARDINAL HEALTHCardinal Health 200, LLCOXQ2026-10-06
10653160393450CENTURIONCENTURION MEDICAL PRODUCTS CORPORATIONOXQ2026-10-05
10198956531673CARDINAL HEALTHCardinal Health 200, LLCOXQ2026-09-30
10198956583771CARDINAL HEALTHCardinal Health 200, LLCOXQ2026-09-30
10198956566088CARDINAL HEALTHCardinal Health 200, LLCOXQ2026-09-29
10198956571143CARDINAL HEALTHCardinal Health 200, LLCOXQ2026-09-29
10198956580428CARDINAL HEALTHCardinal Health 200, LLCOXQ2026-09-29
10198956587120CARDINAL HEALTHCardinal Health 200, LLCOXQ2026-09-29
10198956566644CARDINAL HEALTHCardinal Health 200, LLCOXQ2026-09-25
10198956568280CARDINAL HEALTHCardinal Health 200, LLCOXQ2026-09-25
10198956578357CARDINAL HEALTHCardinal Health 200, LLCOXQ2026-09-25
10198956581654CARDINAL HEALTHCardinal Health 200, LLCOXQ2026-09-25
10198956586178CARDINAL HEALTHCardinal Health 200, LLCOXQ2026-09-25
10198956580268CARDINAL HEALTHCardinal Health 200, LLCOXQ2026-09-22
10198956562271CARDINAL HEALTHCardinal Health 200, LLCOXQ2026-09-21
10198956573550CARDINAL HEALTHCardinal Health 200, LLCOXQ2026-09-21