FDA.reportPublic FDA data

CARDINAL HEALTH

Primary DI
10198956624269
Brand
CARDINAL HEALTH
Company
Cardinal Health 200, LLC
Model
SAN44ADM21
Catalog number
SAN44ADM21
Device description
ANGIO DRAPE CATH LAB SYSTEM PK
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
OEQAngiography/angioplasty kit

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OEQAngiography/Angioplasty KitCardiovascular2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
50198956624267PackageGS14In Commercial Distribution
10198956624269PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
5019895662426750198956624267
1019895662426910198956624269

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
B098AMS19657A0Aligned Medical SolutionsAligned Medical SolutionsOEQ2026-11-02
00884450436936Merit Medical®Merit Medical Systems, Inc.OEQ2026-10-30
B098AMS202330Aligned Medical SolutionsAligned Medical SolutionsOEQ2026-10-30
00884450254677Merit Medical®Merit Medical Systems, Inc.OEQ2026-10-29
10198956560505CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-10-29
10198956568075CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-10-29
10198956586154CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-10-29
10198956588646CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-10-29
10198956590052CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-10-29
10198956610682CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-10-29
10198956611221CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-10-29
10198956615342CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-10-29
10198956618640CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-10-29
10198956618725CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-10-29
10198956619630CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-10-29
10198956619852CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-10-29
10198956620254CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-10-29
10198956620261CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-10-29
10198956621336CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-10-29
10198956622418CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-10-29
10198956622425CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-10-29
00884450429150Merit Medical®Merit Medical Systems, Inc.OEQ2026-10-27
10809160541814Medical Action IndustriesMEDICAL ACTION INDUSTRIES INC.OEQ2026-10-27
10198956605091CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-10-26
10198956607590CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-10-26
10198956610873CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-10-26
10198956620322CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-10-26
10198956106666CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-10-23
10198956530157CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-10-23
10198956563063CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-10-23