FDA.reportPublic FDA data

CARDINAL HEALTH

Primary DI
10198956488243
Brand
CARDINAL HEALTH
Company
Cardinal Health 200, LLC
Model
SCVOCOHP16
Catalog number
SCVOCOHP16
Device description
OPEN HEART PACK
Published
2026-06-05
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
50198956488241PackageGS11In Commercial Distribution
10198956488243PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
5019895648824150198956488241
1019895648824310198956488243

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
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
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
10198956494305CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-06-05