FDA.reportPublic FDA data

CARDINAL HEALTH

Primary DI
10888439409079
Brand
CARDINAL HEALTH
Company
Cardinal Health 200, LLC
Model
SCVOCOHPOA
Catalog number
SCVOCOHPOA
Device description
OPEN HEART PACK
Published
2019-06-12
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
50888439409077PackageGS11In Commercial Distribution
10888439409079PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
5088843940907750888439409077
1088843940907910888439409079

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 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
Contains natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10198956078789CARDINAL HEALTHSBACGTPILESBACGTPILE2026-06-05
10198956231061CARDINAL HEALTHSMA45CSHMCSMA45CSHMC2026-06-05
10198956266063CARDINAL HEALTHSEN32MHRMJSEN32MHRMJ2026-06-05
10198956286665CARDINAL HEALTHPOV2SH01YPOV2SH01Y2026-06-05
10198956305274CARDINAL HEALTHSOP21BPWCBSOP21BPWCB2026-06-05
10198956305861CARDINAL HEALTHSBA30HYCRGSBA30HYCRG2026-06-05
10198956321557CARDINAL HEALTHPVHDMJVCOPVHDMJVCO2026-06-05
10198956330085CARDINAL HEALTHPV13OPEMIPV13OPEMI2026-06-05
10198956332522CARDINAL HEALTHSNE24CRNOOSNE24CRNOO2026-06-05
10198956339231CARDINAL HEALTHSCV22EPSBDSCV22EPSBD2026-06-05
10198956339392CARDINAL HEALTHSBA21BLDCCSBA21BLDCC2026-06-05
10198956344471CARDINAL HEALTHPB4AGYHAFPB4AGYHAF2026-06-05
10198956345928CARDINAL HEALTHSOPOCCAHSCSOPOCCAHSC2026-06-05
10198956349261CARDINAL HEALTHSBA40TRCFESBA40TRCFE2026-06-05
10198956353268CARDINAL HEALTHSCV29SPMMCSCV29SPMMC2026-06-05
10198956354241CARDINAL HEALTHSEN4LHNGRESEN4LHNGRE2026-06-05
10198956359963CARDINAL HEALTHSOP56THIDFSOP56THIDF2026-06-05
10198956364905CARDINAL HEALTHSOP5TKASCFSOP5TKASCF2026-06-05
10198956365902CARDINAL HEALTHSBA22BSSTDSBA22BSSTD2026-06-05
10198956367630CARDINAL HEALTHSOT69CYUSESOT69CYUSE2026-06-05

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00884450107072Merit Medical®Merit Medical Systems, Inc.OEZ2026-06-06
00884450161746Merit Medical®Merit Medical Systems, Inc.OEZ2026-06-06
00884450436745Merit Medical®Merit Medical Systems, Inc.OEZ2026-06-06
10198956321557CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-06-05
10198956330085CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-06-05
10198956339231CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-06-05
10198956353268CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-06-05
10198956402973CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-06-05
10198956415058CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-06-05
10198956433007CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-06-05
10198956451278CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-06-05
10198956474963CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-06-05
10198956477872CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-06-05
10198956479470CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-06-05
10198956482098CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-06-05
10198956483798CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-06-05
10198956485235CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-06-05
10198956488243CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-06-05
10198956488427CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-06-05
10198956489646CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-06-05
10198956490123CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-06-05
10198956491021CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-06-05
10198956491779CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-06-05
10198956491977CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-06-05
10198956492561CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-06-05
10198956493407CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-06-05
10198956493636CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-06-05
10198956493704CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-06-05
10198956493759CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-06-05
10198956493971CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-06-05