FDA.reportPublic FDA data

CARDINAL HEALTH

Primary DI
10198956586123
Brand
CARDINAL HEALTH
Company
Cardinal Health 200, LLC
Model
SAN0VCCU15
Catalog number
SAN0VCCU15
Device description
CARDIAC CATH MOTT PACK
Published
2026-09-22
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
OESCardiac catheterization kit

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OESCardiac Catheterization KitCardiovascular2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
50198956586121PackageGS14In Commercial Distribution
10198956586123PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
5019895658612150198956586121
1019895658612310198956586123

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.

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
10197106992753CARDINAL HEALTHSCV40VP52CSCV40VP52C2026-09-25
10198956169357CARDINAL HEALTHSCV69EVWKASCV69EVWKA2026-09-25
10198956172715CARDINAL HEALTHSBA21PPSCCSBA21PPSCC2026-09-25
10198956321335CARDINAL HEALTHPEHDTRVCKPEHDTRVCK2026-09-25
10198956339729CARDINAL HEALTHSBA22ATMRASBA22ATMRA2026-09-25
10198956374232CARDINAL HEALTHSOP41KASRBSOP41KASRB2026-09-25
10198956383043CARDINAL HEALTHORC3R7765BORC3R7765B2026-09-25
10198956388239CARDINAL HEALTHSOT53CYPOFSOT53CYPOF2026-09-25
10198956393288CARDINAL HEALTHSBA73GPMVBSBA73GPMVB2026-09-25
10198956400801CARDINAL HEALTHSOP3MHPCVCSOP3MHPCVC2026-09-25
10198956402522CARDINAL HEALTHSMA13GLEXDSMA13GLEXD2026-09-25
10198956424654CARDINAL HEALTHPO54TKCMDPO54TKCMD2026-09-25
10198956439849CARDINAL HEALTHSAN69PCKOGSAN69PCKOG2026-09-25
10198956444263CARDINAL HEALTHPV36HPCHEPV36HPCHE2026-09-25
10198956450684CARDINAL HEALTHSMA58CSLOPSMA58CSLOP2026-09-25
10198956461086CARDINAL HEALTHSBACGBPGSHSBACGBPGSH2026-09-25
10198956462205CARDINAL HEALTHPV08TCGHHPV08TCGHH2026-09-25
10198956466159CARDINAL HEALTH03-2656S03-2656S2026-09-25
10198956466838CARDINAL HEALTHSNE35LSFSGSNE35LSFSG2026-09-25
10198956484382CARDINAL HEALTHANE306276AANE306276A2026-09-25

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
B098DDS1159D0Aligned Medical SolutionsAligned Medical SolutionsOES2026-09-26
10198459754210MEDLINEMEDLINE INDUSTRIES, INC.OES2026-09-25
10198459754524MEDLINEMEDLINE INDUSTRIES, INC.OES2026-09-25
10198459755699MEDLINEMEDLINE INDUSTRIES, INC.OES2026-09-25
10198459755705MEDLINEMEDLINE INDUSTRIES, INC.OES2026-09-25
10198459758287MEDLINEMEDLINE INDUSTRIES, INC.OES2026-09-25
10198459758294MEDLINEMEDLINE INDUSTRIES, INC.OES2026-09-25
10198459759291MEDLINEMEDLINE INDUSTRIES, INC.OES2026-09-25
10198459761850MEDLINEMEDLINE INDUSTRIES, INC.OES2026-09-25
10198459766336MEDLINEMEDLINE INDUSTRIES, INC.OES2026-09-25
10198459771224MEDLINEMEDLINE INDUSTRIES, INC.OES2026-09-25
10198459774126MEDLINEMEDLINE INDUSTRIES, INC.OES2026-09-25
10198459775437MEDLINEMEDLINE INDUSTRIES, INC.OES2026-09-25
10198459775666MEDLINEMEDLINE INDUSTRIES, INC.OES2026-09-25
10198459775673MEDLINEMEDLINE INDUSTRIES, INC.OES2026-09-25
10198459775680MEDLINEMEDLINE INDUSTRIES, INC.OES2026-09-25
10198459778827MEDLINEMEDLINE INDUSTRIES, INC.OES2026-09-25
10198459779985MEDLINEMEDLINE INDUSTRIES, INC.OES2026-09-25
10198459784996MEDLINEMEDLINE INDUSTRIES, INC.OES2026-09-25
10198459786808MEDLINEMEDLINE INDUSTRIES, INC.OES2026-09-25
10198459787690MEDLINEMEDLINE INDUSTRIES, INC.OES2026-09-25
10198459788130MEDLINEMEDLINE INDUSTRIES, INC.OES2026-09-25
10198459789717MEDLINEMEDLINE INDUSTRIES, INC.OES2026-09-25
10198459789724MEDLINEMEDLINE INDUSTRIES, INC.OES2026-09-25
10198459791994MEDLINEMEDLINE INDUSTRIES, INC.OES2026-09-25
10198459792007MEDLINEMEDLINE INDUSTRIES, INC.OES2026-09-25
10198459795138MEDLINEMEDLINE INDUSTRIES, INC.OES2026-09-25
10198459796975MEDLINEMEDLINE INDUSTRIES, INC.OES2026-09-25
10198459799143MEDLINEMEDLINE INDUSTRIES, INC.OES2026-09-25
10198459809187MEDLINEMEDLINE INDUSTRIES, INC.OES2026-09-25