FDA.reportPublic FDA data

CARDINAL HEALTH

Primary DI
10198956602311
Brand
CARDINAL HEALTH
Company
Cardinal Health 200, LLC
Model
SANDHCCCM1
Catalog number
SANDHCCCM1
Device description
CMC CARDIAC CATH PACK
Published
2026-10-12
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
50198956602319PackageGS13In Commercial Distribution
10198956602311PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
5019895660231950198956602319
1019895660231110198956602311

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
20885380213851CARDINAL HEALTHCH33225CH332252026-11-02
10192253025316Monoject888151123588815112352021-09-17
20884521014999Monoject888151131088815113102016-09-24
20884521014937Monoject888151111088815111102016-09-24
10192253046526Kendall55546BAMD55546BAMD2023-10-09
10192253046786Kendall55588BAMDX55588BAMDX2025-09-09
10885380031687PROTEXIS2D72NT65X2D72NT65X2018-04-13
10192253025309Monoject888151120188815112012021-09-17
10192253069693Curity6309G6309G2026-10-29
10198956253209CARDINAL HEALTHSOTCGUPTRDSOTCGUPTRD2026-10-29
10198956323209CARDINAL HEALTHPGX4LTPREPGX4LTPRE2026-10-29
10198956359888CARDINAL HEALTHSOPOCHAWMCSOPOCHAWMC2026-10-29
10198956381759CARDINAL HEALTH34-6599D34-6599D2026-10-29
10198956423534CARDINAL HEALTHSAN11PD10BSAN11PD10B2026-10-29
10198956428195CARDINAL HEALTHPOV2CHCPUPOV2CHCPU2026-10-29
10198956435292CARDINAL HEALTH03-6720C03-6720C2026-10-29
10198956468184CARDINAL HEALTHSNE7CLMNHMSNE7CLMNHM2026-10-29
10198956485372CARDINAL HEALTHSMA23GLNIGSMA23GLNIG2026-10-29
10198956496101CARDINAL HEALTHSMA4EDCBDCSMA4EDCBDC2026-10-29
10198956503519CARDINAL HEALTHSBA4LGLGRFSBA4LGLGRF2026-10-29

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
B098AMS14230A0Aligned Medical SolutionsAligned Medical SolutionsOES2026-11-02
10198956609877CARDINAL HEALTHCardinal Health 200, LLCOES2026-10-29
10198956612587CARDINAL HEALTHCardinal Health 200, LLCOES2026-10-29
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
10198956602748CARDINAL HEALTHCardinal Health 200, LLCOES2026-10-12
10809160540145HalyardAVID MEDICAL, INC.OES2026-10-08
10198956593817CARDINAL HEALTHCardinal Health 200, LLCOES2026-10-06