FDA.reportPublic FDA data

CARDINAL HEALTH

Primary DI
10195594882617
Brand
CARDINAL HEALTH
Company
Cardinal Health 200, LLC
Model
SCV41OHT17
Catalog number
SCV41OHT17
Device description
OPEN HEART PACK PART 2 OF 2
Published
2022-10-18
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
50195594882615PackageGS11In Commercial Distribution
10195594882617PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
5019559488261550195594882615
1019559488261710195594882617

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
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10198956037908CARDINAL HEALTH08-3641G08-3641G2026-09-04
10198956210240CARDINAL HEALTHAMN213116EAMN213116E2026-09-04
10198956310933CARDINAL HEALTHANE439532GANE439532G2026-09-04
10198956331891CARDINAL HEALTHSAN13ARBIFSAN13ARBIF2026-09-04
10198956333420CARDINAL HEALTHSANX4IPSSCSANX4IPSSC2026-09-04
10198956359291CARDINAL HEALTHSMA54BGEVCSMA54BGEVC2026-09-04
10198956379084CARDINAL HEALTHSOP33EXMSGSOP33EXMSG2026-09-04
10198956395947CARDINAL HEALTHSOPMIMPMSBSOPMIMPMSB2026-09-04
10198956398467CARDINAL HEALTHSBA44LPCEASBA44LPCEA2026-09-04
10198956415195CARDINAL HEALTHSCVCGOHILHSCVCGOHILH2026-09-04
10198956421462CARDINAL HEALTHSOPMVSAUCJSOPMVSAUCJ2026-09-04
10198956426061CARDINAL HEALTHSCVDKMVOGDSCVDKMVOGD2026-09-04
10198956428102CARDINAL HEALTHSAN13RDEMSSAN13RDEMS2026-09-04
10198956454989CARDINAL HEALTHSOP23KPNLCSOP23KPNLC2026-09-04
10198956462977CARDINAL HEALTHSBA48LCRHCSBA48LCRHC2026-09-04
10198956463394CARDINAL HEALTHSEN23TAPCLSEN23TAPCL2026-09-04
10198956464520CARDINAL HEALTHSMA23GPNVBSMA23GPNVB2026-09-04
10198956465510CARDINAL HEALTH34-3217C34-3217C2026-09-04
10198956468399CARDINAL HEALTHPO1DTHAMQPO1DTHAMQ2026-09-04
10198956468481CARDINAL HEALTHSMAOCGLSTGSMAOCGLSTG2026-09-04

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00884450431252Merit Medical®Merit Medical Systems, Inc.OEZ2026-09-04
00884450431979Merit Medical®Merit Medical Systems, Inc.OEZ2026-09-04
10198956415195CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-09-04
10198956426061CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-09-04
10198956512528CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-09-04
10198956513617CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-09-04
10198956517202CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-09-04
10198956543522CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-09-04
10198956548190CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-09-04
10198956548497CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-09-04
10198956549340CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-09-04
10198956553217CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-09-04
10198956558618CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-09-04
10198956559684CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-09-04
10198956561861CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-09-04
10198956562202CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-09-04
10198956562417CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-09-04
10198956563704CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-09-04
10198956564848CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-09-04
10198956566767CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-09-04
10198956568457CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-09-04
10198956569522CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-09-04
10198956570337CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-09-04
10198956570481CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-09-04
10198956570535CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-09-04
10198956570573CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-09-04
10198956570610CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-09-04
10198956571570CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-09-04
10198956571884CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-09-04
10198956572379CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-09-04