FDA.reportPublic FDA data

CARDINAL HEALTH

Primary DI
10885425723935
Brand
CARDINAL HEALTH
Company
Cardinal Health 200, LLC
Model
PC54AFVAJ
Catalog number
PC54AFVAJ
Device description
KIT,AV PACK
Published
2016-08-09
Public version status
Update
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
50885425723933PackageGS11In Commercial Distribution
10885425723935PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
5088542572393350885425723933
1088542572393510885425723935

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
10198956182004CARDINAL HEALTHSOPCNEPBSFSOPCNEPBSF2026-07-06
10198956202320CARDINAL HEALTH34-9397L34-9397L2026-07-06
10198956261952CARDINAL HEALTH08-1780F08-1780F2026-07-06
10198956331235CARDINAL HEALTH32-7479R32-7479R2026-07-06
10198956358942CARDINAL HEALTHSEN4LTAGRCSEN4LTAGRC2026-07-06
10198956373068CARDINAL HEALTHSOP53HIOHCSOP53HIOHC2026-07-06
10198956373655CARDINAL HEALTHSANCGANMWCSANCGANMWC2026-07-06
10198956380615CARDINAL HEALTHENDDK4659DENDDK4659D2026-07-06
10198956381124CARDINAL HEALTH34-0950C34-0950C2026-07-06
10198956388789CARDINAL HEALTHSMA11DCWNFSMA11DCWNF2026-07-06
10198956389007CARDINAL HEALTHSEN35ENCFDSEN35ENCFD2026-07-06
10198956393424CARDINAL HEALTHSBADHLPNVCSBADHLPNVC2026-07-06
10198956397361CARDINAL HEALTHSAN29MY87ISAN29MY87I2026-07-06
10198956398689CARDINAL HEALTHSAN3MARCVCSAN3MARCVC2026-07-06
10198956407053CARDINAL HEALTHSOP69TJMSBSOP69TJMSB2026-07-06
10198956414693CARDINAL HEALTHSOP48TKLODSOP48TKLOD2026-07-06
10198956416079CARDINAL HEALTHPN11SF36DPN11SF36D2026-07-06
10198956416482CARDINAL HEALTHSAN11CC26CSAN11CC26C2026-07-06
10198956423077CARDINAL HEALTHPBCGDCBLIPBCGDCBLI2026-07-06
10198956427198CARDINAL HEALTHSBA13SMBTBSBA13SMBTB2026-07-06

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10198956397361CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-07-06
10198956488465CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-07-06
10198956491922CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-07-06
10198956492059CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-07-06
10198956492073CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-07-06
10198956494794CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-07-06
10198956496262CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-07-06
10198956497214CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-07-06
10198956502888CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-07-06
10198956509443CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-07-06
10198956513891CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-07-06
10198956525016CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-07-06
10198956525160CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-07-06
10198956525207CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-07-06
10198956525405CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-07-06
10198956525481CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-07-06
10198956525528CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-07-06
10198956525566CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-07-06
10198956525641CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-07-06
10198956525726CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-07-06
10198956525894CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-07-06
10198956526648CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-07-06
10198956526815CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-07-06
10198956527430CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-07-06
10809160526484HalyardAVID MEDICAL, INC.OEZ2026-07-06
10809160526514HalyardAVID MEDICAL, INC.OEZ2026-07-06
00884450423790Merit Medical®Merit Medical Systems, Inc.OEZ2026-07-03
00884450079973Merit Medical®Merit Medical Systems, Inc.OEZ2026-06-09
00884450101537Merit Medical®Merit Medical Systems, Inc.OEZ2026-06-09
00884450101568Merit Medical®Merit Medical Systems, Inc.OEZ2026-06-09