FDA.reportPublic FDA data

CARDINAL HEALTH

Primary DI
10198956489622
Brand
CARDINAL HEALTH
Company
Cardinal Health 200, LLC
Model
PV23DAM20
Catalog number
PV23DAM20
Device description
KIT, CABG
Published
2026-06-01
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
50198956489620PackageGS11In Commercial Distribution
10198956489622PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
5019895648962050198956489620
1019895648962210198956489622

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic surgical procedure kit, medicatedA collection of various sterile orthopaedic surgical instruments, dressings, and the necessary materials, which includes a pharmaceutical(s) intended to be used to perform an orthopaedic surgical procedure, however the kit is not dedicated to orthopaedic implantation. 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
10192253033502Monoject118030055511803005552022-10-21
10630140029332CONVERTORS29459294592016-06-28
10630140031403CONVERTORS29461294612016-06-28
10885380026577CONVERTORS29435294352016-06-28
10885380034862CONVERTORS74210742102016-06-28
10885380038075CONVERTORS29520295202016-06-28
10885380053740CONVERTORS29456294562016-06-22
10885380058134CONVERTORSD1062D10622016-06-29
10885380058387CONVERTORS945094502016-06-28
10885380062278CONVERTORS944494442016-06-22
10885380062285CONVERTORS755475542016-06-28
10885380062308CONVERTORS955695562016-07-08
10885380063664CONVERTORS29452294522016-06-28
10885380071539CONVERTORS956295622016-07-13
10885380071652CONVERTORS29417294172016-06-28
10885380071690CONVERTORS29458294582016-06-28
10885380108624CONVERTORS29430294302016-06-22
10885380108648CONVERTORS29447294472016-06-22
10885380108655CONVERTORS29448294482016-06-22
10885380108662CONVERTORS29449294492016-06-22

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00884450426630Merit Medical®Merit Medical Systems, Inc.OEZ2026-06-03
00884450437438Merit Medical®Merit Medical Systems, Inc.OEZ2026-06-03
00884450486887Merit Medical®Merit Medical Systems, Inc.OEZ2026-06-03
10198956320123CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-06-03
10198956328938CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-06-03
10198956444027CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-06-03
10198956468023CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-06-03
10198956477230CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-06-03
10198956486843CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-06-03
10198956489073CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-06-03
10198956490468CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-06-03
10198956490529CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-06-03
10198956492721CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-06-03
10198956496613CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-06-03
10198956498662CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-06-03
10198956500440CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-06-03
00884450424087Merit Medical®Merit Medical Systems, Inc.OEZ2026-06-02
00884450435403Merit Medical®Merit Medical Systems, Inc.OEZ2026-06-02
00884450474549Merit Medical®Merit Medical Systems, Inc.OEZ2026-06-02
00884450474556Merit Medical®Merit Medical Systems, Inc.OEZ2026-06-02
00884450474563Merit Medical®Merit Medical Systems, Inc.OEZ2026-06-02
10198956311282CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-06-01
10198956340145CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-06-01
10198956392281CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-06-01
10198956420816CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-06-01
10198956428089CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-06-01
10198956429345CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-06-01
10198956436428CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-06-01
10198956457140CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-06-01
10198956458796CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-06-01