FDA.reportPublic FDA data

CARDINAL HEALTH

Primary DI
10198956479449
Brand
CARDINAL HEALTH
Company
Cardinal Health 200, LLC
Model
SAN5ADPKSI
Catalog number
SAN5ADPKSI
Device description
DIAGNOSTIC PACK
Published
2026-06-05
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
OIPRadiology-diagnostic kit

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OIPRadiology-Diagnostic KitRadiology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
50198956479447PackageGS12In Commercial Distribution
10198956479449PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
5019895647944750198956479447
1019895647944910198956479449

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
10198956600904CARDINAL HEALTH03B3645M03B3645M2026-11-03
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10198956619388CARDINAL HEALTHCardinal Health 200, LLCOIP2026-11-03
10198956568884CARDINAL HEALTHCardinal Health 200, LLCOIP2026-10-26
10198956318748CARDINAL HEALTHCardinal Health 200, LLCOIP2026-10-23
10198956601932CARDINAL HEALTHCardinal Health 200, LLCOIP2026-10-13
10198956530065CARDINAL HEALTHCardinal Health 200, LLCOIP2026-10-12
10198956582316CARDINAL HEALTHCardinal Health 200, LLCOIP2026-09-29
10198956586369CARDINAL HEALTHCardinal Health 200, LLCOIP2026-09-29
10198956507135CARDINAL HEALTHCardinal Health 200, LLCOIP2026-09-22
10198956561748CARDINAL HEALTHCardinal Health 200, LLCOIP2026-08-26
10198956545496CARDINAL HEALTHCardinal Health 200, LLCOIP2026-08-17
10198956458482CARDINAL HEALTHCardinal Health 200, LLCOIP2026-07-27
10198956507074CARDINAL HEALTHCardinal Health 200, LLCOIP2026-07-27
10198956421226CARDINAL HEALTHCardinal Health 200, LLCOIP2026-07-20
10198956494749CARDINAL HEALTHCardinal Health 200, LLCOIP2026-07-20
10198956491526CARDINAL HEALTHCardinal Health 200, LLCOIP2026-07-09
10198956527959CARDINAL HEALTHCardinal Health 200, LLCOIP2026-07-09
10198956525252CARDINAL HEALTHCardinal Health 200, LLCOIP2026-07-06
10198956498693CARDINAL HEALTHCardinal Health 200, LLCOIP2026-06-08
10198956436220CARDINAL HEALTHCardinal Health 200, LLCOIP2026-06-01
10198956473911CARDINAL HEALTHCardinal Health 200, LLCOIP2026-06-01
10198956484696CARDINAL HEALTHCardinal Health 200, LLCOIP2026-06-01
10809160471623Medical Action IndustriesMEDICAL ACTION INDUSTRIES INC.OIP2025-07-07
10197106094143CARDINAL HEALTHCardinal Health 200, LLCOIP2024-01-10
10809160404553Medical Action IndustriesMEDICAL ACTION INDUSTRIES INC.OIP2023-07-10
10195594704599CARDINAL HEALTHCardinal Health 200, LLCOIP2023-06-01
10195594763831CARDINAL HEALTHCardinal Health 200, LLCOIP2023-05-16
10197106102053CARDINAL HEALTHCardinal Health 200, LLCOIP2023-03-15
10197106050521CARDINAL HEALTHCardinal Health 200, LLCOIP2023-03-08
10197106098493CARDINAL HEALTHCardinal Health 200, LLCOIP2023-03-01
10197106061718CARDINAL HEALTHCardinal Health 200, LLCOIP2023-02-16