FDA.reportPublic FDA data

CARDINAL HEALTH

Primary DI
10198956602748
Brand
CARDINAL HEALTH
Company
Cardinal Health 200, LLC
Model
SAN11CCU13
Catalog number
SAN11CCU13
Device description
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
50198956602746PackageGS13In Commercial Distribution
10198956602748PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
5019895660274650198956602746
1019895660274810198956602748

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
10198956077348CARDINAL HEALTHSCV57RAKPQSCV57RAKPQ2026-10-12
10198956137547CARDINAL HEALTHPV35VKMBCPV35VKMBC2026-10-12
10198956194632CARDINAL HEALTHSAN33MPMPCSAN33MPMPC2026-10-12
10198956276437CARDINAL HEALTHSOPCNBERVBSOPCNBERVB2026-10-12
10198956301719CARDINAL HEALTHSOP53PKBSCSOP53PKBSC2026-10-12
10198956331259CARDINAL HEALTH32-1024F32-1024F2026-10-12
10198956333611CARDINAL HEALTHPOCGHNWTGPOCGHNWTG2026-10-12
10198956352230CARDINAL HEALTHSAN40SLRWBSAN40SLRWB2026-10-12
10198956361041CARDINAL HEALTHSOP44SPKSCSOP44SPKSC2026-10-12
10198956384439CARDINAL HEALTHSOP32LSISFSOP32LSISF2026-10-12
10198956388376CARDINAL HEALTHSOPCGTHOMESOPCGTHOME2026-10-12
10198956391239CARDINAL HEALTHSOT12CYMOCSOT12CYMOC2026-10-12
10198956399051CARDINAL HEALTHSUT44BPSCBSUT44BPSCB2026-10-12
10198956421240CARDINAL HEALTHSEY23CTRCPSEY23CTRCP2026-10-12
10198956460393CARDINAL HEALTHSEN30EEPRBSEN30EEPRB2026-10-12
10198956463875CARDINAL HEALTH02-0891H02-0891H2026-10-12
10198956471887CARDINAL HEALTHSCV54VCWMUSCV54VCWMU2026-10-12
10198956491298CARDINAL HEALTH31-1019F31-1019F2026-10-12
10198956493803CARDINAL HEALTHSNE11CR83GSNE11CR83G2026-10-12
10198956507425CARDINAL HEALTHSBA42BPSMBSBA42BPSMB2026-10-12

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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
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
10198956598546CARDINAL HEALTHCardinal Health 200, LLCOES2026-10-06
10198956601062CARDINAL HEALTHCardinal Health 200, LLCOES2026-10-06
10809160539545HalyardAVID MEDICAL, INC.OES2026-10-01
10198956488847CARDINAL HEALTHCardinal Health 200, LLCOES2026-09-30
10198956516946CARDINAL HEALTHCardinal Health 200, LLCOES2026-09-30
10198956592308CARDINAL HEALTHCardinal Health 200, LLCOES2026-09-30
10198956593459CARDINAL HEALTHCardinal Health 200, LLCOES2026-09-30
10198956596641CARDINAL HEALTHCardinal Health 200, LLCOES2026-09-30
10809160539477HalyardAVID MEDICAL, INC.OES2026-09-30
10198956461963CARDINAL HEALTHCardinal Health 200, LLCOES2026-09-29
10809160539262HalyardAVID MEDICAL, INC.OES2026-09-29
B098AMS194460Aligned Medical SolutionsAligned Medical SolutionsOES2026-09-28
B098DDS1159D0Aligned Medical SolutionsAligned Medical SolutionsOES2026-09-26
10198459754210MEDLINEMEDLINE INDUSTRIES, INC.OES2026-09-25
10198459754524MEDLINEMEDLINE INDUSTRIES, INC.OES2026-09-25
10198459755699MEDLINEMEDLINE INDUSTRIES, INC.OES2026-09-25
10198459755705MEDLINEMEDLINE INDUSTRIES, INC.OES2026-09-25
10198459758287MEDLINEMEDLINE INDUSTRIES, INC.OES2026-09-25
10198459758294MEDLINEMEDLINE INDUSTRIES, INC.OES2026-09-25
10198459759291MEDLINEMEDLINE INDUSTRIES, INC.OES2026-09-25