FDA.reportPublic FDA data

CARDINAL HEALTH

Primary DI
10197106566718
Brand
CARDINAL HEALTH
Company
Cardinal Health 200, LLC
Model
SCVHFOHM22
Catalog number
SCVHFOHM22
Device description
OPEN HEART A AND B PACKS
Published
2024-02-07
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
OEZCardiovascular procedure kit

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OEZCardiovascular Procedure KitCardiovascular2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
50197106566716PackageGS11In Commercial Distribution
10197106566718PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
5019710656671650197106566716
1019710656671810197106566718

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.

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
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
10198956513020CARDINAL 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