FDA.reportPublic FDA data

CARDINAL HEALTH

Primary DI
10195594862893
Brand
CARDINAL HEALTH
Company
Cardinal Health 200, LLC
Model
SAN23CRVAB
Catalog number
SAN23CRVAB
Device description
CARDIAC CATH PACK
Published
2022-10-27
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
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
50195594862891PackageGS12In Commercial Distribution
10195594862893PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
5019559486289150195594862891
1019559486289310195594862893

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 Temperature15 Degrees Celsius30 Degrees Celsius

Regulatory Flags#

DUNS number
961027315
Device count
1
Premarket exempt
true
Kit
true
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true
No natural rubber latex
true

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
10809160531884HalyardAVID MEDICAL, INC.OES2026-08-27
10809160531891HalyardAVID MEDICAL, INC.OES2026-08-27
10198956557901CARDINAL HEALTHCardinal Health 200, LLCOES2026-08-26
10198956557918CARDINAL HEALTHCardinal Health 200, LLCOES2026-08-26
10198956561762CARDINAL HEALTHCardinal Health 200, LLCOES2026-08-26
10809160531679HalyardAVID MEDICAL, INC.OES2026-08-26
10809160531273HalyardAVID MEDICAL, INC.OES2026-08-21
10809160531280HalyardAVID MEDICAL, INC.OES2026-08-21
10809160531396HalyardAVID MEDICAL, INC.OES2026-08-21
10809160530801HalyardAVID MEDICAL, INC.OES2026-08-19
10198956546301CARDINAL HEALTHCardinal Health 200, LLCOES2026-08-17
10198956554481CARDINAL HEALTHCardinal Health 200, LLCOES2026-08-17
B098AMS188600Aligned Medical SolutionsAligned Medical SolutionsOES2026-08-03
10198956543287CARDINAL HEALTHCardinal Health 200, LLCOES2026-07-31
10198956543614CARDINAL HEALTHCardinal Health 200, LLCOES2026-07-31
10198956544550CARDINAL HEALTHCardinal Health 200, LLCOES2026-07-31
10809160528259HalyardAVID MEDICAL, INC.OES2026-07-31
10198956517776CARDINAL HEALTHCardinal Health 200, LLCOES2026-07-27
10198956534926CARDINAL HEALTHCardinal Health 200, LLCOES2026-07-27
10198956535404CARDINAL HEALTHCardinal Health 200, LLCOES2026-07-27
10809160527672HalyardAVID MEDICAL, INC.OES2026-07-21
10198956528062CARDINAL HEALTHCardinal Health 200, LLCOES2026-07-20
10809160527580HalyardAVID MEDICAL, INC.OES2026-07-20
10809160527436HalyardAVID MEDICAL, INC.OES2026-07-17
10198956335523CARDINAL HEALTHCardinal Health 200, LLCOES2026-07-16
10198956509283CARDINAL HEALTHCardinal Health 200, LLCOES2026-07-16
10198956524880CARDINAL HEALTHCardinal Health 200, LLCOES2026-07-16
10198956529083CARDINAL HEALTHCardinal Health 200, LLCOES2026-07-16
10198956529410CARDINAL HEALTHCardinal Health 200, LLCOES2026-07-16
10809160527252HalyardAVID MEDICAL, INC.OES2026-07-16