FDA.reportPublic FDA data

CARDINAL HEALTH

Primary DI
10198956339583
Brand
CARDINAL HEALTH
Company
Cardinal Health 200, LLC
Model
SAN4JARH10
Catalog number
SAN4JARH10
Device description
HP ARTERIOGRAM DRAPE PACK
Published
2026-01-26
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
OERAngioscopic valvulotome kit

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OERAngioscopic Valvulotome KitCardiovascular2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
50198956339581PackageGS12In Commercial Distribution
10198956339583PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
5019895633958150198956339581
1019895633958310198956339583

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
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
10198956569744CARDINAL HEALTHCardinal Health 200, LLCOER2026-09-04
10198956539440CARDINAL HEALTHCardinal Health 200, LLCOER2026-07-31
10198956494688CARDINAL HEALTHCardinal Health 200, LLCOER2026-07-27
10198956534650CARDINAL HEALTHCardinal Health 200, LLCOER2026-07-27
10198956527669CARDINAL HEALTHCardinal Health 200, LLCOER2026-07-16
10198956492035CARDINAL HEALTHCardinal Health 200, LLCOER2026-07-09
10198956494565CARDINAL HEALTHCardinal Health 200, LLCOER2026-07-09
10198956398689CARDINAL HEALTHCardinal Health 200, LLCOER2026-07-06
10198956514102CARDINAL HEALTHCardinal Health 200, LLCOER2026-06-23
10198956487345CARDINAL HEALTHCardinal Health 200, LLCOER2026-05-25
10198956454514CARDINAL HEALTHCardinal Health 200, LLCOER2026-04-27
10198956454545CARDINAL HEALTHCardinal Health 200, LLCOER2026-04-15
10198956448421CARDINAL HEALTHCardinal Health 200, LLCOER2026-04-14
10198956422339CARDINAL HEALTHCardinal Health 200, LLCOER2026-03-23
50198956422337CARDINAL HEALTHCardinal Health 200, LLCOER2026-03-23
10198956387522CARDINAL HEALTHCardinal Health 200, LLCOER2026-02-24
10198956385184CARDINAL HEALTHCardinal Health 200, LLCOER2026-02-23
50198956385182CARDINAL HEALTHCardinal Health 200, LLCOER2026-02-23
10198956341951CARDINAL HEALTHCardinal Health 200, LLCOER2026-02-20
50198956341959CARDINAL HEALTHCardinal Health 200, LLCOER2026-02-20
50198956339581CARDINAL HEALTHCardinal Health 200, LLCOER2026-01-26
10198956268524CARDINAL HEALTHCardinal Health 200, LLCOER2025-12-11
50198956268522CARDINAL HEALTHCardinal Health 200, LLCOER2025-12-11
10198956266599CARDINAL HEALTHCardinal Health 200, LLCOER2025-11-21
10198956248502CARDINAL HEALTHCardinal Health 200, LLCOER2025-10-27
10198956169111CARDINAL HEALTHCardinal Health 200, LLCOER2025-08-18
50198956169119CARDINAL HEALTHCardinal Health 200, LLCOER2025-08-18
10198956160194CARDINAL HEALTHCardinal Health 200, LLCOER2025-08-06
50198956160192CARDINAL HEALTHCardinal Health 200, LLCOER2025-08-06
10198956144958CARDINAL HEALTHCardinal Health 200, LLCOER2025-07-16