FDA.reportPublic FDA data

CARDINAL HEALTH

Primary DI
10198956554603
Brand
CARDINAL HEALTH
Company
Cardinal Health 200, LLC
Model
PVV2CC145
Catalog number
PVV2CC145
Device description
KIT,OPEN HEART BASIC PRESBYTER
Published
2026-08-17
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
50198956554601PackageGS11In Commercial Distribution
10198956554603PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
5019895655460150198956554601
1019895655460310198956554603

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 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
false
No natural rubber latex
true
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10192253048049Kendall924492442026-06-15
10192253047981Kendall923692362026-06-09
10192253047998Kendall923892382026-06-09
10192253048001Kendall923992392026-06-09
10192253048018Kendall924092402026-06-09
10192253048025Kendall924292422026-06-09
10192253048032Kendall924392432026-06-09
10192253047943Kendall92319231-2026-05-12
10192253047950Kendall923292322026-05-12
10192253048087Kendall93519351-2024-03-04
10192253048094Kendall93549354-2024-03-04
10192253048100Kendall93559355-2024-03-04
10192253048117Kendall93569356-2024-03-04
10192253047967Kendall92339233-2026-05-26
10198956361003CARDINAL HEALTHSOTOCURGRBSOTOCURGRB2026-08-18
10198956366107CARDINAL HEALTH34-2285H34-2285H2026-08-18
10198956381100CARDINAL HEALTH34-7731C34-7731C2026-08-18
10198956463738CARDINAL HEALTHPE23EANLDPE23EANLD2026-08-18
10198956469990CARDINAL HEALTHSNE54LCDECSNE54LCDEC2026-08-18
10198956502512CARDINAL HEALTHSCVDHAPMCLSCVDHAPMCL2026-08-18

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00884450148228Merit Medical®Merit Medical Systems, Inc.OEZ2026-08-19
10809160530795HalyardAVID MEDICAL, INC.OEZ2026-08-19
10198956502512CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-08-18
10198956539082CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-08-18
10198956548084CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-08-18
10198956556881CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-08-18
10198956557789CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-08-18
10198956557802CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-08-18
10809160530252HalyardAVID MEDICAL, INC.OEZ2026-08-18
10809160530337HalyardAVID MEDICAL, INC.OEZ2026-08-18
10809160530535HalyardAVID MEDICAL, INC.OEZ2026-08-18
10809160530634HalyardAVID MEDICAL, INC.OEZ2026-08-18
10809160530665HalyardAVID MEDICAL, INC.OEZ2026-08-18
10198956494800CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-08-17
10198956500501CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-08-17
10198956508361CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-08-17
10198956508408CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-08-17
10198956522619CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-08-17
10198956535053CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-08-17
10198956541054CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-08-17
10198956541740CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-08-17
10198956541887CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-08-17
10198956548770CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-08-17
10198956549418CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-08-17
10198956550209CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-08-17
10198956550919CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-08-17
10198956553293CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-08-17
10198956554641CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-08-17
B098AMS196180Aligned Medical SolutionsAligned Medical SolutionsOEZ2026-08-16
00884450467220Merit Medical®Merit Medical Systems, Inc.OEZ2026-08-14