FDA.reportPublic FDA data

CARDINAL HEALTH

Primary DI
10198956471757
Brand
CARDINAL HEALTH
Company
Cardinal Health 200, LLC
Model
SAN43CPUSD
Catalog number
SAN43CPUSD
Device description
CARDIAC CATH PACK
Published
2026-06-05
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
50198956471755PackageGS14In Commercial Distribution
10198956471757PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
5019895647175550198956471755
1019895647175710198956471757

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
10198956078789CARDINAL HEALTHSBACGTPILESBACGTPILE2026-06-05
10198956231061CARDINAL HEALTHSMA45CSHMCSMA45CSHMC2026-06-05
10198956266063CARDINAL HEALTHSEN32MHRMJSEN32MHRMJ2026-06-05
10198956286665CARDINAL HEALTHPOV2SH01YPOV2SH01Y2026-06-05
10198956305274CARDINAL HEALTHSOP21BPWCBSOP21BPWCB2026-06-05
10198956305861CARDINAL HEALTHSBA30HYCRGSBA30HYCRG2026-06-05
10198956321557CARDINAL HEALTHPVHDMJVCOPVHDMJVCO2026-06-05
10198956330085CARDINAL HEALTHPV13OPEMIPV13OPEMI2026-06-05
10198956332522CARDINAL HEALTHSNE24CRNOOSNE24CRNOO2026-06-05
10198956339231CARDINAL HEALTHSCV22EPSBDSCV22EPSBD2026-06-05
10198956339392CARDINAL HEALTHSBA21BLDCCSBA21BLDCC2026-06-05
10198956344471CARDINAL HEALTHPB4AGYHAFPB4AGYHAF2026-06-05
10198956345928CARDINAL HEALTHSOPOCCAHSCSOPOCCAHSC2026-06-05
10198956349261CARDINAL HEALTHSBA40TRCFESBA40TRCFE2026-06-05
10198956353268CARDINAL HEALTHSCV29SPMMCSCV29SPMMC2026-06-05
10198956354241CARDINAL HEALTHSEN4LHNGRESEN4LHNGRE2026-06-05
10198956359963CARDINAL HEALTHSOP56THIDFSOP56THIDF2026-06-05
10198956364905CARDINAL HEALTHSOP5TKASCFSOP5TKASCF2026-06-05
10198956365902CARDINAL HEALTHSBA22BSSTDSBA22BSSTD2026-06-05
10198956367630CARDINAL HEALTHSOT69CYUSESOT69CYUSE2026-06-05

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10198956495777CARDINAL HEALTHCardinal Health 200, LLCOES2026-06-05
10809160522639HalyardAVID MEDICAL, INC.OES2026-06-04
10198956459960CARDINAL HEALTHCardinal Health 200, LLCOES2026-06-03
10198956490734CARDINAL HEALTHCardinal Health 200, LLCOES2026-06-01
10198956492325CARDINAL HEALTHCardinal Health 200, LLCOES2026-06-01
10198956494206CARDINAL HEALTHCardinal Health 200, LLCOES2026-06-01
10080196726707Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OES2024-12-22
10193489016390Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OES2023-12-21
10193489067231Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OES2023-12-21
10193489439298Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OES2023-07-29
10193489455601Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OES2023-06-13
10193489409987Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OES2023-06-08
10193489414059Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OES2023-06-08
10193489414073Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OES2023-06-08
10193489416046Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OES2023-06-08
10193489416169Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OES2023-06-08
10193489417197Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OES2023-06-08
10193489418903Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OES2023-06-08
10193489421125Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OES2023-06-08
10193489421286Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OES2023-06-08
10193489421682Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OES2023-06-08
10193489421699Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OES2023-06-08
10193489421910Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OES2023-06-08
10193489423273Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OES2023-06-08
10193489425413Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OES2023-06-08
10193489425871Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OES2023-06-08
10193489426168Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OES2023-06-08
10193489426182Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OES2023-06-08
10193489426502Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OES2023-06-08
10193489427752Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OES2023-06-08