FDA.reportPublic FDA data

CARDINAL HEALTH

Primary DI
10198956600904
Brand
CARDINAL HEALTH
Company
Cardinal Health 200, LLC
Model
03B3645M
Catalog number
03B3645M
Device description
CENTRAL LINE DRSG CHANGE KIT
Published
2026-11-03
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
50198956600902PackageGS150In Commercial Distribution
10198956600904PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
5019895660090250198956600902
1019895660090410198956600904

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
10198956519664CARDINAL HEALTHSOT73CYCHCSOT73CYCHC2026-11-03
10198956545199CARDINAL HEALTH03E0114D03E0114D2026-11-03
10198956548800CARDINAL HEALTHSVA73RVKAGSVA73RVKAG2026-11-03
10198956559851CARDINAL HEALTH08A6335B08A6335B2026-11-03
10198956569805CARDINAL HEALTHSOP73TJKMCSOP73TJKMC2026-11-03
10198956575646CARDINAL HEALTH34-016AF34-016AF2026-11-03
10198956577206CARDINAL HEALTHSOTOCCYKCISOTOCCYKCI2026-11-03
10198956579873CARDINAL HEALTHORC548814BORC548814B2026-11-03
10198956582019CARDINAL HEALTHSBA54LCVVCSBA54LCVVC2026-11-03
10198956592971CARDINAL HEALTHSMA13CSSGFSMA13CSSGF2026-11-03
10198956603806CARDINAL HEALTHPOHDASVCNOPOHDASVCNO2026-11-03
10198956603936CARDINAL HEALTHSOPHDUTVCOSOPHDUTVCO2026-11-03
10198956607231CARDINAL HEALTH03C8060P03C8060P2026-11-03
10198956607811CARDINAL HEALTHSOP13EPJNBSOP13EPJNB2026-11-03
10198956611047CARDINAL HEALTHSOT43CPPPBSOT43CPPPB2026-11-03
10198956612433CARDINAL HEALTHSOP73TJCR8SOP73TJCR82026-11-03
10198956612556CARDINAL HEALTHSOP73TJCR9SOP73TJCR92026-11-03
10198956614406CARDINAL HEALTHSUT40CBJU1SUT40CBJU12026-11-03
10198956615465CARDINAL HEALTHSOP12TJ55LSOP12TJ55L2026-11-03
10198956616455CARDINAL HEALTHSBAHDMNMJFSBAHDMNMJF2026-11-03

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10198956545199CARDINAL HEALTHCardinal Health 200, LLCOXQ2026-11-03
10198956607231CARDINAL HEALTHCardinal Health 200, LLCOXQ2026-11-03
00849884007725VYGONVygon CorporationOXQ2026-10-29
10198956435292CARDINAL HEALTHCardinal Health 200, LLCOXQ2026-10-29
10198956592247CARDINAL HEALTHCardinal Health 200, LLCOXQ2026-10-29
10198956593633CARDINAL HEALTHCardinal Health 200, LLCOXQ2026-10-29
10198956606821CARDINAL HEALTHCardinal Health 200, LLCOXQ2026-10-29
10653160395690MEDLINEMEDLINE INDUSTRIES, INC.OXQ2026-10-29
10653160395874MEDLINEMEDLINE INDUSTRIES, INC.OXQ2026-10-29
10653160396017MEDLINEMEDLINE INDUSTRIES, INC.OXQ2026-10-29
10653160396024MEDLINEMEDLINE INDUSTRIES, INC.OXQ2026-10-29
10653160396031MEDLINEMEDLINE INDUSTRIES, INC.OXQ2026-10-29
10653160395461MEDLINEMEDLINE INDUSTRIES, INC.OXQ2026-10-24
10653160395713MEDLINEMEDLINE INDUSTRIES, INC.OXQ2026-10-24
10653160395720MEDLINEMEDLINE INDUSTRIES, INC.OXQ2026-10-24
10653160395782MEDLINEMEDLINE INDUSTRIES, INC.OXQ2026-10-24
10653160395805MEDLINEMEDLINE INDUSTRIES, INC.OXQ2026-10-24
10653160395812MEDLINEMEDLINE INDUSTRIES, INC.OXQ2026-10-24
10653160395911MEDLINEMEDLINE INDUSTRIES, INC.OXQ2026-10-24
10198956594739CARDINAL HEALTHCardinal Health 200, LLCOXQ2026-10-23
10198956596276CARDINAL HEALTHCardinal Health 200, LLCOXQ2026-10-23
10198956531666CARDINAL HEALTHCardinal Health 200, LLCOXQ2026-10-15
10198956565470CARDINAL HEALTHCardinal Health 200, LLCOXQ2026-10-15
10198956577374CARDINAL HEALTHCardinal Health 200, LLCOXQ2026-10-15
10198956588134CARDINAL HEALTHCardinal Health 200, LLCOXQ2026-10-15
10198956593749CARDINAL HEALTHCardinal Health 200, LLCOXQ2026-10-15
10198956593756CARDINAL HEALTHCardinal Health 200, LLCOXQ2026-10-15
10653160393894MEDLINEMEDLINE INDUSTRIES, INC.OXQ2026-10-15
10653160394310MEDLINEMEDLINE INDUSTRIES, INC.OXQ2026-10-15
10653160394426MEDLINEMEDLINE INDUSTRIES, INC.OXQ2026-10-15