FDA.reportPublic FDA data

CARDINAL HEALTH

Primary DI
10198956627482
Brand
CARDINAL HEALTH
Company
Cardinal Health 200, LLC
Model
SAN4JCCCM7
Catalog number
SAN4JCCCM7
Device description
PK CARDIAC CATH ADULT CM
Published
2026-10-29
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
OEZCardiovascular procedure kit

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OEZCardiovascular Procedure KitCardiovascular2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
50198956627480PackageGS12In Commercial Distribution
10198956627482PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
5019895662748050198956627480
1019895662748210198956627482

GMDN Terms#

Term, Definition table
TermDefinition
Cardiothoracic surgical procedure kit, non-medicated, single-useA collection of various sterile cardiothoracic surgical instruments, dressings, and materials intended to be used to assist a range of cardiothoracic surgical procedures; it does not contain pharmaceuticals. The kit is intended only for use during cardiothoracic surgery but is not dedicated to a specific type of cardiothoracic surgical procedure. 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
10192253069693Curity6309G6309G2026-10-29
10198956253209CARDINAL HEALTHSOTCGUPTRDSOTCGUPTRD2026-10-29
10198956323209CARDINAL HEALTHPGX4LTPREPGX4LTPRE2026-10-29
10198956359888CARDINAL HEALTHSOPOCHAWMCSOPOCHAWMC2026-10-29
10198956381759CARDINAL HEALTH34-6599D34-6599D2026-10-29
10198956423534CARDINAL HEALTHSAN11PD10BSAN11PD10B2026-10-29
10198956428195CARDINAL HEALTHPOV2CHCPUPOV2CHCPU2026-10-29
10198956435292CARDINAL HEALTH03-6720C03-6720C2026-10-29
10198956468184CARDINAL HEALTHSNE7CLMNHMSNE7CLMNHM2026-10-29
10198956485372CARDINAL HEALTHSMA23GLNIGSMA23GLNIG2026-10-29
10198956496101CARDINAL HEALTHSMA4EDCBDCSMA4EDCBDC2026-10-29
10198956503519CARDINAL HEALTHSBA4LGLGRFSBA4LGLGRF2026-10-29
10198956504745CARDINAL HEALTHSCV3MLVCVBSCV3MLVCVB2026-10-29
10198956513310CARDINAL HEALTHSOP23SACACSOP23SACAC2026-10-29
10198956517240CARDINAL HEALTHSOP31KAOSXSOP31KAOSX2026-10-29
10198956521032CARDINAL HEALTHSENCGTACPCSENCGTACPC2026-10-29
10198956531932CARDINAL HEALTHSBA8CBPSPBSBA8CBPSPB2026-10-29
10198956533592CARDINAL HEALTHSAN42PMTMPSAN42PMTMP2026-10-29
10198956533653CARDINAL HEALTHSCV4AAAJHVSCV4AAAJHV2026-10-29
10198956534490CARDINAL HEALTHPU13CPAJEPU13CPAJE2026-10-29

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10198956423534CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-10-29
10198956504745CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-10-29
10198956533592CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-10-29
10198956533653CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-10-29
10198956544727CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-10-29
10198956549289CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-10-29
10198956595224CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-10-29
10198956604162CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-10-29
10198956607040CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-10-29
10198956609952CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-10-29
10198956612235CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-10-29
10198956612327CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-10-29
10198956612471CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-10-29
10198956612778CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-10-29
10198956613430CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-10-29
10198956613447CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-10-29
10198956613546CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-10-29
10198956615557CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-10-29
10198956616608CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-10-29
10198956617896CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-10-29
10198956618428CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-10-29
10198956618619CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-10-29
10198956618732CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-10-29
10198956618770CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-10-29
10198956619463CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-10-29
10198956619845CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-10-29
10198956620360CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-10-29
10198956620667CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-10-29
10198956620841CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-10-29
10198956622272CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-10-29