FDA.reportPublic FDA data

CARDINAL HEALTH

Primary DI
10195594417369
Brand
CARDINAL HEALTH
Company
Cardinal Health 200, LLC
Model
PVHDCGVC6
Catalog number
PVHDCGVC6
Device description
KIT, ORP CABG
Published
2021-11-05
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
50195594417367PackageGS11In Commercial Distribution
10195594417369PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
5019559441736750195594417367
1019559441736910195594417369

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
10192253072723Curity8441268441262026-10-08
10192253072730Curity8441368441362026-10-08
10192253072747Curity8441468441462026-10-08
10192253072754Curity8441568441562026-10-08
10192253072761Curity8441668441662026-10-08
10192253072778Curity8441768441762026-10-08
10192253072785Curity8442168442162026-10-08
10192253072792Curity8442268442262026-10-08
10192253072808Curity8442368442362026-10-08
10192253072815Curity8442468442462026-10-08
10192253072822Curity8442568442562026-10-08
10885380207150Curity4100A4100A2026-10-08
10885380207167Curity4101A4101A2026-10-08
10885380207174Curity4102A4102A2026-10-08
50885380207202Curity41000410002026-10-08
50885380207219Curity4103A4103A2026-10-08
50885380207226Curity4104A4104A2026-10-08
50885380207233Curity4105A4105A2026-10-08
50885380207240Curity42000420002026-10-08
50885380207257Curity43000430002026-10-08

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10809160540121HalyardAVID MEDICAL, INC.OEZ2026-10-08
10809160540176HalyardAVID MEDICAL, INC.OEZ2026-10-08
10809160540183HalyardAVID MEDICAL, INC.OEZ2026-10-08
00884450031469Merit Medical®Merit Medical Systems, Inc.OEZ2026-10-07
10809160540060HalyardAVID MEDICAL, INC.OEZ2026-10-07
00884450376713Merit Medical®Merit Medical Systems, Inc.OEZ2026-10-06
00884450428344Merit Medical®Merit Medical Systems, Inc.OEZ2026-10-06
10198956171954CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-10-06
10198956480865CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-10-06
10198956511262CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-10-06
10198956539518CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-10-06
10198956543188CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-10-06
10198956550964CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-10-06
10198956551169CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-10-06
10198956564626CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-10-06
10198956566866CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-10-06
10198956568471CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-10-06
10198956577510CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-10-06
10198956581401CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-10-06
10198956584020CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-10-06
10198956589445CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-10-06
10198956589902CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-10-06
10198956592926CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-10-06
10198956592933CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-10-06
10198956593145CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-10-06
10198956593473CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-10-06
10198956593855CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-10-06
10198956594838CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-10-06
10198956595392CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-10-06
10198956595453CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-10-06