FDA.reportPublic FDA data

CARDINAL HEALTH

Primary DI
10198956606203
Brand
CARDINAL HEALTH
Company
Cardinal Health 200, LLC
Model
SANDHCCCM2
Catalog number
SANDHCCCM2
Device description
CMC CARDIAC CATH PACK
Published
2026-10-13
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
OESCardiac catheterization kit

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OESCardiac Catheterization KitCardiovascular2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
50198956606201PackageGS13In Commercial Distribution
10198956606203PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
5019895660620150198956606201
1019895660620310198956606203

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
10198459809224MEDLINEMEDLINE INDUSTRIES, INC.OES2026-11-03
10198459814969MEDLINEMEDLINE INDUSTRIES, INC.OES2026-11-03
10198459815508MEDLINEMEDLINE INDUSTRIES, INC.OES2026-11-03
10198956626232CARDINAL HEALTHCardinal Health 200, LLCOES2026-11-03
B098AMS14230A0Aligned Medical SolutionsAligned Medical SolutionsOES2026-11-02
10198956609877CARDINAL HEALTHCardinal Health 200, LLCOES2026-10-29
10198956612587CARDINAL HEALTHCardinal Health 200, LLCOES2026-10-29
10809160542040HalyardMEDICAL ACTION INDUSTRIES INC.OES2026-10-28
10809160541944HALYARDAVID MEDICAL, INC.OES2026-10-27
10198956593077CARDINAL HEALTHCardinal Health 200, LLCOES2026-10-26
10198956611504CARDINAL HEALTHCardinal Health 200, LLCOES2026-10-26
10198956534834CARDINAL HEALTHCardinal Health 200, LLCOES2026-10-23
10198956605237CARDINAL HEALTHCardinal Health 200, LLCOES2026-10-23
10198956605343CARDINAL HEALTHCardinal Health 200, LLCOES2026-10-23
10198956608009CARDINAL HEALTHCardinal Health 200, LLCOES2026-10-23
10198956608191CARDINAL HEALTHCardinal Health 200, LLCOES2026-10-23
10809160541159HalyardAVID MEDICAL, INC.OES2026-10-22
10809160541241HalyardAVID MEDICAL, INC.OES2026-10-22
10809160541302HalyardAVID MEDICAL, INC.OES2026-10-22
10198956518964CARDINAL HEALTHCardinal Health 200, LLCOES2026-10-19
10198956584419CARDINAL HEALTHCardinal Health 200, LLCOES2026-10-19
10198956590298CARDINAL HEALTHCardinal Health 200, LLCOES2026-10-19
10198956608702CARDINAL HEALTHCardinal Health 200, LLCOES2026-10-19
10809160540688HalyardAVID MEDICAL, INC.OES2026-10-16
10809160540596HalyardAVID MEDICAL, INC.OES2026-10-13
10198956592766CARDINAL HEALTHCardinal Health 200, LLCOES2026-10-12
10198956597518CARDINAL HEALTHCardinal Health 200, LLCOES2026-10-12
10198956598416CARDINAL HEALTHCardinal Health 200, LLCOES2026-10-12
10198956598522CARDINAL HEALTHCardinal Health 200, LLCOES2026-10-12
10198956598539CARDINAL HEALTHCardinal Health 200, LLCOES2026-10-12