FDA.reportPublic FDA data

CARDINAL HEALTH

Primary DI
10198956598546
Brand
CARDINAL HEALTH
Company
Cardinal Health 200, LLC
Model
SAN11LHH24
Catalog number
SAN11LHH24
Device description
HUMC LEFT HEART PACK
Published
2026-10-06
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
OESCardiac catheterization kit

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OESCardiac Catheterization KitCardiovascular2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
50198956598544PackageGS12In Commercial Distribution
10198956598546PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
5019895659854450198956598544
1019895659854610198956598546

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
50885380213234Kendall3320533205B2026-10-28
50885380213241Kendall3320633206B2026-10-28
50885380213258Kendall3320733207B2026-10-28
10885380169922CARDINAL HEALTH212WPR212WPR2020-01-13
20884521100449Monoject8611U8611U2016-09-24
20884521100456Monoject8612U8612U2016-09-24
20192253024668Monoject888120201888812020182026-07-15
10192253040203Argyle1604091604092025-01-08
10192253040210Argyle43201432012025-01-08
10192253040241Argyle43308433082025-01-08
10192253040258Argyle43309433092025-01-08
10192253040265Argyle43311433112025-01-08
10192253040289Argyle888816011988881601192025-01-08
10192253040326Argyle888816040888881604082025-01-08
10192253040333Argyle888816042488881604242025-01-08
10192253040340Argyle888816043288881604322025-01-08
10192253040395Argyle888816083888881608382025-01-08
10192253040401Argyle888816085388881608532025-01-08
10192253046656Kendall55566BAMD55566BAMD2023-10-09
10195594567743CARDINAL HEALTHSBACNUBOL3SBACNUBOL32022-03-01

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10809160542040HalyardMEDICAL ACTION INDUSTRIES INC.OES2026-10-28
10809160541944HALYARDAVID MEDICAL, INC.OES2026-10-27
10198956593077CARDINAL HEALTHCardinal Health 200, LLCOES2026-10-26
10198956611504CARDINAL HEALTHCardinal Health 200, LLCOES2026-10-26
10198956534834CARDINAL HEALTHCardinal Health 200, LLCOES2026-10-23
10198956605237CARDINAL HEALTHCardinal Health 200, LLCOES2026-10-23
10198956605343CARDINAL HEALTHCardinal Health 200, LLCOES2026-10-23
10198956608009CARDINAL HEALTHCardinal Health 200, LLCOES2026-10-23
10198956608191CARDINAL HEALTHCardinal Health 200, LLCOES2026-10-23
10809160541159HalyardAVID MEDICAL, INC.OES2026-10-22
10809160541241HalyardAVID MEDICAL, INC.OES2026-10-22
10809160541302HalyardAVID MEDICAL, INC.OES2026-10-22
10198956518964CARDINAL HEALTHCardinal Health 200, LLCOES2026-10-19
10198956584419CARDINAL HEALTHCardinal Health 200, LLCOES2026-10-19
10198956590298CARDINAL HEALTHCardinal Health 200, LLCOES2026-10-19
10198956608702CARDINAL HEALTHCardinal Health 200, LLCOES2026-10-19
10809160540688HalyardAVID MEDICAL, INC.OES2026-10-16
10198956606203CARDINAL HEALTHCardinal Health 200, LLCOES2026-10-13
10809160540596HalyardAVID MEDICAL, INC.OES2026-10-13
10198956592766CARDINAL HEALTHCardinal Health 200, LLCOES2026-10-12
10198956597518CARDINAL HEALTHCardinal Health 200, LLCOES2026-10-12
10198956598416CARDINAL HEALTHCardinal Health 200, LLCOES2026-10-12
10198956598522CARDINAL HEALTHCardinal Health 200, LLCOES2026-10-12
10198956598539CARDINAL HEALTHCardinal Health 200, LLCOES2026-10-12
10198956602311CARDINAL HEALTHCardinal Health 200, LLCOES2026-10-12
10198956602748CARDINAL HEALTHCardinal Health 200, LLCOES2026-10-12
10809160540145HalyardAVID MEDICAL, INC.OES2026-10-08
10198956593817CARDINAL HEALTHCardinal Health 200, LLCOES2026-10-06
10198956593930CARDINAL HEALTHCardinal Health 200, LLCOES2026-10-06
10198956596016CARDINAL HEALTHCardinal Health 200, LLCOES2026-10-06