FDA.reportPublic FDA data

CARDINAL HEALTH

Primary DI
10888439377828
Brand
CARDINAL HEALTH
Company
Cardinal Health 200, LLC
Model
PC69HEE12
Catalog number
PC69HEE12
Device description
KIT, OPEN HEART A,B,C
Published
2019-02-18
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
50888439377826PackageGS11In Commercial Distribution
10888439377828PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
5088843937782650888439377826
1088843937782810888439377828

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
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