FDA.reportPublic FDA data

CARDINAL HEALTH

Primary DI
10198956543287
Brand
CARDINAL HEALTH
Company
Cardinal Health 200, LLC
Model
SAN40CPB11
Catalog number
SAN40CPB11
Device description
CARDIAC CATH PACK
Published
2026-07-31
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
50198956543285PackageGS12In Commercial Distribution
10198956543287PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
5019895654328550198956543285
1019895654328710198956543287

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 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
10192253004243Monoject31143699311436992026-08-03
10192253004250Monoject31143798311437982026-08-03
10192253004304Monoject31300878313008782026-08-03
20192253050353Vistec659165912023-05-24
10192253004458Monoject85121851212026-07-31
10192253004465Monoject8513018513012026-07-31
10192253004472Monoject85131851312026-07-31
10192253004915Monoject890689062026-07-31
10192253005066Monoject89671896712026-07-31
10192253005295Monoject8990Y8990Y2026-07-31
10192253005516Monoject8535Y8535Y2026-07-31
10192253005622Monoject8970Y8970Y2026-07-31
10197106933145CARDINAL HEALTHPV42CJTMZPV42CJTMZ2026-07-31
10197106950012CARDINAL HEALTHSAN56IPIDFSAN56IPIDF2026-07-31
10198956027596CARDINAL HEALTHSCV73CAHFHSCV73CAHFH2026-07-31
10198956327603CARDINAL HEALTH26-8545D26-8545D2026-07-31
10198956342217CARDINAL HEALTHPB15LHFCLPB15LHFCL2026-07-31
10198956352315CARDINAL HEALTHPW45KFMSAPW45KFMSA2026-07-31
10198956353961CARDINAL HEALTHSNEHBNEECDSNEHBNEECD2026-07-31
10198956364998CARDINAL HEALTHSBADHHMCFDSBADHHMCFD2026-07-31

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
B098AMS188600Aligned Medical SolutionsAligned Medical SolutionsOES2026-08-03
10198956543614CARDINAL HEALTHCardinal Health 200, LLCOES2026-07-31
10198956544550CARDINAL HEALTHCardinal Health 200, LLCOES2026-07-31
10809160528259HalyardAVID MEDICAL, INC.OES2026-07-31
10198956517776CARDINAL HEALTHCardinal Health 200, LLCOES2026-07-27
10198956534926CARDINAL HEALTHCardinal Health 200, LLCOES2026-07-27
10198956535404CARDINAL HEALTHCardinal Health 200, LLCOES2026-07-27
10809160527672HalyardAVID MEDICAL, INC.OES2026-07-21
10198956528062CARDINAL HEALTHCardinal Health 200, LLCOES2026-07-20
10809160527580HalyardAVID MEDICAL, INC.OES2026-07-20
10809160527436HalyardAVID MEDICAL, INC.OES2026-07-17
10198956335523CARDINAL HEALTHCardinal Health 200, LLCOES2026-07-16
10198956509283CARDINAL HEALTHCardinal Health 200, LLCOES2026-07-16
10198956524880CARDINAL HEALTHCardinal Health 200, LLCOES2026-07-16
10198956529083CARDINAL HEALTHCardinal Health 200, LLCOES2026-07-16
10198956529410CARDINAL HEALTHCardinal Health 200, LLCOES2026-07-16
10809160527252HalyardAVID MEDICAL, INC.OES2026-07-16
10198956478107CARDINAL HEALTHCardinal Health 200, LLCOES2026-07-09
10198956518131CARDINAL HEALTHCardinal Health 200, LLCOES2026-07-09
10198956526983CARDINAL HEALTHCardinal Health 200, LLCOES2026-07-09
10198956528208CARDINAL HEALTHCardinal Health 200, LLCOES2026-07-09
10809160526859HalyardAVID MEDICAL, INC.OES2026-07-08
10198956463400CARDINAL HEALTHCardinal Health 200, LLCOES2026-07-06
10198956525993CARDINAL HEALTHCardinal Health 200, LLCOES2026-07-06
10809160526361HalyardAVID MEDICAL, INC.OES2026-06-26
10809160526262HalyardAVID MEDICAL, INC.OES2026-06-25
10809160525937HalyardAVID MEDICAL, INC.OES2026-06-24
10809160525968HalyardAVID MEDICAL, INC.OES2026-06-24
10809160526019HalyardAVID MEDICAL, INC.OES2026-06-24
10809160526132HalyardAVID MEDICAL, INC.OES2026-06-24