FDA.reportPublic FDA data

CARDINAL HEALTH

Primary DI
10198956614062
Brand
CARDINAL HEALTH
Company
Cardinal Health 200, LLC
Model
PV4GMVNH3
Catalog number
PV4GMVNH3
Device description
KIT,MINOR VASCULAR
Published
2026-10-26
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
50198956614060PackageGS11In Commercial Distribution
10198956614062PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
5019895661406050198956614060
1019895661406210198956614062

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
00885380173700Curity1806G1806G2026-10-26
10192253010015Kangaroo7761507761502026-10-26
10198956294127CARDINAL HEALTHSOPHDTHWWCSOPHDTHWWC2026-10-26
10198956515376CARDINAL HEALTHSBA69FFKWRSBA69FFKWR2026-10-26
10198956516342CARDINAL HEALTHSMA54GLPOISMA54GLPOI2026-10-26
10198956519138CARDINAL HEALTHSMA55CPYKFSMA55CPYKF2026-10-26
10198956542006CARDINAL HEALTH20-485AI20-485AI2026-10-26
10198956555839CARDINAL HEALTHAMN696315EAMN696315E2026-10-26
10198956562905CARDINAL HEALTHSEY57KC00GSEY57KC00G2026-10-26
10198956565784CARDINAL HEALTHSNEOCSPSBCSNEOCSPSBC2026-10-26
10198956566705CARDINAL HEALTHPN41LMLAKPN41LMLAK2026-10-26
10198956568884CARDINAL HEALTH27-9143M27-9143M2026-10-26
10198956573437CARDINAL HEALTHSAN12AIUVFSAN12AIUVF2026-10-26
10198956575028CARDINAL HEALTHSMA73UGKSISMA73UGKSI2026-10-26
10198956576940CARDINAL HEALTHSOP69SH45CSOP69SH45C2026-10-26
10198956577107CARDINAL HEALTHSEN4AEAJHWSEN4AEAJHW2026-10-26
10198956577282CARDINAL HEALTHSBAOCMBKCRSBAOCMBKCR2026-10-26
10198956578869CARDINAL HEALTHSBAOCMJWYJSBAOCMJWYJ2026-10-26
10198956590359CARDINAL HEALTHSBA4QFLFPCSBA4QFLFPC2026-10-26
10198956591981CARDINAL HEALTHSOP69EEKRESOP69EEKRE2026-10-26

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10198956611023CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-10-26
10198956612846CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-10-26
10198956613379CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-10-26
10198956616875CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-10-26
10198956621510CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-10-26
10809160541562HalyardAVID MEDICAL, INC.OEZ2026-10-26
10809160541579HalyardAVID MEDICAL, INC.OEZ2026-10-26
10809160541616HalyardAVID MEDICAL, INC.OEZ2026-10-26
00884450431542Merit Medical®Merit Medical Systems, Inc.OEZ2026-10-24
10198956409552CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-10-23
10198956571259CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-10-23
10198956579378CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-10-23
10198956592049CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-10-23
10198956601147CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-10-23
10198956602687CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-10-23
10198956604179CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-10-23
10198956605459CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-10-23
10198956606029CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-10-23
10198956606609CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-10-23
10198956607620CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-10-23
10198956608474CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-10-23
10198956608818CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-10-23
10198956609198CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-10-23
10198956609631CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-10-23
10198956609730CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-10-23
10198956609860CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-10-23
10198956610026CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-10-23
10198956610125CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-10-23
10198956611160CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-10-23
10198956612440CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-10-23