FDA.reportPublic FDA data

CARDINAL HEALTH

Primary DI
10198956513020
Brand
CARDINAL HEALTH
Company
Cardinal Health 200, LLC
Model
PV4ECVHTI
Catalog number
PV4ECVHTI
Device description
KIT, HMT CV SET UP
Published
2026-07-31
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
50198956513028PackageGS11In Commercial Distribution
10198956513020PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
5019895651302850198956513028
1019895651302010198956513020

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
10192253004243Monoject31143699311436992026-08-03
10192253004250Monoject31143798311437982026-08-03
10192253004304Monoject31300878313008782026-08-03
20192253050353Vistec659165912023-05-24
10192253004458Monoject85121851212026-07-31
10192253004465Monoject8513018513012026-07-31
10192253004472Monoject85131851312026-07-31
10192253004915Monoject890689062026-07-31
10192253005066Monoject89671896712026-07-31
10192253005295Monoject8990Y8990Y2026-07-31
10192253005516Monoject8535Y8535Y2026-07-31
10192253005622Monoject8970Y8970Y2026-07-31
10197106933145CARDINAL HEALTHPV42CJTMZPV42CJTMZ2026-07-31
10197106950012CARDINAL HEALTHSAN56IPIDFSAN56IPIDF2026-07-31
10198956027596CARDINAL HEALTHSCV73CAHFHSCV73CAHFH2026-07-31
10198956327603CARDINAL HEALTH26-8545D26-8545D2026-07-31
10198956342217CARDINAL HEALTHPB15LHFCLPB15LHFCL2026-07-31
10198956352315CARDINAL HEALTHPW45KFMSAPW45KFMSA2026-07-31
10198956353961CARDINAL HEALTHSNEHBNEECDSNEHBNEECD2026-07-31
10198956364998CARDINAL HEALTHSBADHHMCFDSBADHHMCFD2026-07-31

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10809160528464HalyardAVID MEDICAL, INC.OEZ2026-08-03
10809160528563HalyardAVID MEDICAL, INC.OEZ2026-08-03
10809160528600HalyardAVID MEDICAL, INC.OEZ2026-08-03
00884450447093Merit Medical®Merit Medical Systems, Inc.OEZ2026-08-01
10197106933145CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-07-31
10198956027596CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-07-31
10198956421615CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-07-31
10198956439177CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-07-31
10198956464292CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-07-31
10198956491663CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-07-31
10198956500235CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-07-31
10198956512856CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-07-31
10198956523746CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-07-31
10198956533059CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-07-31
10198956534162CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-07-31
10198956535954CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-07-31
10198956536203CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-07-31
10198956536234CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-07-31
10198956536418CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-07-31
10198956536937CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-07-31
10198956538443CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-07-31
10198956538528CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-07-31
10198956538740CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-07-31
10198956538764CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-07-31
10198956539112CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-07-31
10198956539150CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-07-31
10198956539464CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-07-31
10198956541146CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-07-31
10198956541313CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-07-31
10198956541320CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-07-31