FDA.reportPublic FDA data

CARDINAL HEALTH

Primary DI
10198956563407
Brand
CARDINAL HEALTH
Company
Cardinal Health 200, LLC
Model
PV63CVS52
Catalog number
PV63CVS52
Device description
KIT, CARDIOVASCULAR
Published
2026-08-26
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
50198956563405PackageGS11In Commercial Distribution
10198956563407PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
5019895656340550198956563405
1019895656340710198956563407

GMDN Terms#

Term, Definition table
TermDefinition
Cardiothoracic surgical procedure kit, medicated, single-useA collection of various sterile cardiothoracic surgical instruments, dressings, and materials including a pharmaceutical component, intended to be used to assist a range of cardiothoracic surgical procedures. 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 intended to be sterilized prior to use.

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
true
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10885380152412CARDINAL HEALTHCAX2304BACAX2304BA2017-10-12
10885380152429CARDINAL HEALTHCAX2304BDCAX2304BD2017-10-12
10885380152559CARDINAL HEALTHCAX2330LACAX2330LA2021-10-27
10885380152566CARDINAL HEALTHCAX2330LDCAX2330LD2021-10-27
10885380171109CARDINAL HEALTHCAX1230LACAX1230LA2020-06-21
10885380171116CARDINAL HEALTHCAX1230LDCAX1230LD2020-06-21
10885380171147CARDINAL HEALTHCAX3030LACAX3030LA2020-06-21
10885380171154CARDINAL HEALTHCAX3030LDCAX3030LD2020-06-21
10885380164545CARDINAL HEALTHCAX5030LACAX5030LA2020-03-18
10885380164552CARDINAL HEALTHCAX5030LDCAX5030LD2020-03-18
10198956286306CARDINAL HEALTHSOPOCLRWSHSOPOCLRWSH2026-08-26
10198956330221CARDINAL HEALTHSBA5FLCABBSBA5FLCABB2026-08-26
10198956346246CARDINAL HEALTHSCVHDVPAGCSCVHDVPAGC2026-08-26
10198956373105CARDINAL HEALTHSNE43LMSUBSNE43LMSUB2026-08-26
10198956384330CARDINAL HEALTHSMA45DCWPBSMA45DCWPB2026-08-26
10198956409767CARDINAL HEALTHSEN18EAVBOSEN18EAVBO2026-08-26
10198956417533CARDINAL HEALTHSEY13EPLHMSEY13EPLHM2026-08-26
10198956423633CARDINAL HEALTHPOCGEXBLJPOCGEXBLJ2026-08-26
10198956437746CARDINAL HEALTH38-8433D38-8433D2026-08-26
10198956461048CARDINAL HEALTHSOP18FTSTMSOP18FTSTM2026-08-26

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10809160531907HalyardAVID MEDICAL, INC.OEZ2026-08-27
10809160532072HalyardAVID MEDICAL, INC.OEZ2026-08-27
00884450437766Merit Medical®Merit Medical Systems, Inc.OEZ2026-08-26
10198956346246CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-08-26
10198956473836CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-08-26
10198956532243CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-08-26
10198956534810CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-08-26
10198956542266CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-08-26
10198956542730CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-08-26
10198956545816CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-08-26
10198956547858CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-08-26
10198956548138CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-08-26
10198956549951CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-08-26
10198956557314CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-08-26
10198956559295CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-08-26
10198956560963CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-08-26
10198956561755CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-08-26
10198956561786CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-08-26
10198956561830CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-08-26
10198956562158CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-08-26
10198956562165CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-08-26
10198956562318CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-08-26
10198956562547CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-08-26
10198956562868CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-08-26
10198956563353CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-08-26
10198956563711CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-08-26
10198956563971CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-08-26
10809160531808HalyardAVID MEDICAL, INC.OEZ2026-08-26
00884450432082Merit Medical®Merit Medical Systems, Inc.OEZ2026-08-25
10809160531600HalyardAVID MEDICAL, INC.OEZ2026-08-25