FDA.reportPublic FDA data

CARDINAL HEALTH

Primary DI
10198956110335
Brand
CARDINAL HEALTH
Company
Cardinal Health 200, LLC
Model
SAN3MARCVA
Catalog number
SAN3MARCVA
Device description
ANGIO ARTERIOGRAM PACK
Published
2025-07-07
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
OERAngioscopic valvulotome kit

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OERAngioscopic Valvulotome KitCardiovascular2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
50198956110333PackageGS13In Commercial Distribution
10198956110335PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
5019895611033350198956110333
1019895611033510198956110335

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
10192253047981Kendall923692362026-06-09
10192253047998Kendall923892382026-06-09
10192253048001Kendall923992392026-06-09
10192253048018Kendall924092402026-06-09
10192253048025Kendall924292422026-06-09
10192253048032Kendall924392432026-06-09
10192253046205Webcol511051102024-09-05
10192253047066Webcol68186818-2025-06-10
10192253047073Webcol6818-16818-12025-07-28
10884521008427Dover502750272016-09-24
10885380052538CARDINAL HEALTHC-CB2SC-CB2S2023-08-07
10885380052545CARDINAL HEALTHC-CB3SC-CB3S2023-08-07
10885380052569CARDINAL HEALTHC-CB6SC-CB6S2023-08-07
10885380052613CARDINAL HEALTHC-CB6C-CB62023-08-07
10885380107801CARDINAL HEALTHABP1201ABP12012016-07-22
10885380107818CARDINAL HEALTHASC1201ASC12012016-07-22
10885380107825CARDINAL HEALTHASC1210ASC12102016-07-22
10885380107832CARDINAL HEALTHASC1211ASC12112016-07-22
10885380107849CARDINAL HEALTHASC1220ASC12202016-07-22
10885380107856CARDINAL HEALTHASC1221ASC12212016-07-22

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10198956487345CARDINAL HEALTHCardinal Health 200, LLCOER2026-05-25
10198956454514CARDINAL HEALTHCardinal Health 200, LLCOER2026-04-27
10198956454545CARDINAL HEALTHCardinal Health 200, LLCOER2026-04-15
10198956448421CARDINAL HEALTHCardinal Health 200, LLCOER2026-04-14
10198956422339CARDINAL HEALTHCardinal Health 200, LLCOER2026-03-23
50198956422337CARDINAL HEALTHCardinal Health 200, LLCOER2026-03-23
10198956387522CARDINAL HEALTHCardinal Health 200, LLCOER2026-02-24
10198956385184CARDINAL HEALTHCardinal Health 200, LLCOER2026-02-23
50198956385182CARDINAL HEALTHCardinal Health 200, LLCOER2026-02-23
10198956341951CARDINAL HEALTHCardinal Health 200, LLCOER2026-02-20
50198956341959CARDINAL HEALTHCardinal Health 200, LLCOER2026-02-20
10198956339583CARDINAL HEALTHCardinal Health 200, LLCOER2026-01-26
50198956339581CARDINAL HEALTHCardinal Health 200, LLCOER2026-01-26
10198956268524CARDINAL HEALTHCardinal Health 200, LLCOER2025-12-11
50198956268522CARDINAL HEALTHCardinal Health 200, LLCOER2025-12-11
10198956266599CARDINAL HEALTHCardinal Health 200, LLCOER2025-11-21
10198956248502CARDINAL HEALTHCardinal Health 200, LLCOER2025-10-27
10198956169111CARDINAL HEALTHCardinal Health 200, LLCOER2025-08-18
50198956169119CARDINAL HEALTHCardinal Health 200, LLCOER2025-08-18
10198956160194CARDINAL HEALTHCardinal Health 200, LLCOER2025-08-06
50198956160192CARDINAL HEALTHCardinal Health 200, LLCOER2025-08-06
10198956144958CARDINAL HEALTHCardinal Health 200, LLCOER2025-07-16
50198956144956CARDINAL HEALTHCardinal Health 200, LLCOER2025-07-16
10198956136656CARDINAL HEALTHCardinal Health 200, LLCOER2025-07-10
50198956136654CARDINAL HEALTHCardinal Health 200, LLCOER2025-07-10
50198956110333CARDINAL HEALTHCardinal Health 200, LLCOER2025-07-07
10198956116986CARDINAL HEALTHCardinal Health 200, LLCOER2025-06-23
50198956116984CARDINAL HEALTHCardinal Health 200, LLCOER2025-06-23
10198956104365CARDINAL HEALTHCardinal Health 200, LLCOER2025-06-10
50198956104363CARDINAL HEALTHCardinal Health 200, LLCOER2025-06-10