FDA.reportPublic FDA data

CARDINAL HEALTH

Primary DI
10198956587243
Brand
CARDINAL HEALTH
Company
Cardinal Health 200, LLC
Model
SAN33APUWA
Catalog number
SAN33APUWA
Device description
ANGIO 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
OEQAngiography/angioplasty kit

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OEQAngiography/Angioplasty KitCardiovascular2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
50198956587241PackageGS14In Commercial Distribution
10198956587243PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
5019895658724150198956587241
1019895658724310198956587243

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
10198956537798CARDINAL HEALTHSOP53TOWRGSOP53TOWRG2026-10-13
10198956539914CARDINAL HEALTHSOP48EX85ASOP48EX85A2026-10-13
10198956541658CARDINAL HEALTHSAN1DRPUNCSAN1DRPUNC2026-10-13
10198956545182CARDINAL HEALTHSOP53SLVLLSOP53SLVLL2026-10-13
10198956549050CARDINAL HEALTHSOP45THBMJSOP45THBMJ2026-10-13
10198956559516CARDINAL HEALTH08-0857C08-0857C2026-10-13
10198956562950CARDINAL HEALTHSBA43MPMADSBA43MPMAD2026-10-13
10198956563223CARDINAL HEALTHSOP42ARBTHSOP42ARBTH2026-10-13
10198956564237CARDINAL HEALTHSEY45BPPAESEY45BPPAE2026-10-13
10198956570740CARDINAL HEALTHSEN48ESSNASEN48ESSNA2026-10-13
10198956570993CARDINAL HEALTH34-2403F34-2403F2026-10-13
10198956573024CARDINAL HEALTHSMA54MGFMPSMA54MGFMP2026-10-13
10198956577084CARDINAL HEALTH08-0857D08-0857D2026-10-13
10198956578753CARDINAL HEALTH34-7753A34-7753A2026-10-13
10198956588721CARDINAL HEALTHSMA40DERWDSMA40DERWD2026-10-13
10198956589810CARDINAL HEALTHSBAOCRPS30SBAOCRPS302026-10-13
10198956592698CARDINAL HEALTHSAN53ANOV6SAN53ANOV62026-10-13
10198956593770CARDINAL HEALTHSOTOCURGR3SOTOCURGR32026-10-13
10198956595071CARDINAL HEALTH31-826AW31-826AW2026-10-13
10198956597891CARDINAL HEALTHSBA43RPUSESBA43RPUSE2026-10-13

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00884450385760Merit Medical®Merit Medical Systems, Inc.OEQ2026-10-13
10198956592698CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-10-13
10198956551282CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-10-12
10198956595491CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-10-12
10198956599369CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-10-12
10198956600126CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-10-12
10198956601611CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-10-12
10198956601727CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-10-12
10198956602557CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-10-12
10198956602564CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-10-12
10198956606326CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-10-12
10809160540510HALYARDAVID MEDICAL, INC.OEQ2026-10-12
10198956391215CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-10-06
10198956420526CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-10-06
10198956504578CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-10-06
10198956517332CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-10-06
10198956542228CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-10-06
10198956551251CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-10-06
10198956556157CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-10-06
10198956581715CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-10-06
10198956589049CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-10-06
10198956590557CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-10-06
10198956592711CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-10-06
10198956593947CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-10-06
10198956594685CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-10-06
10198956596177CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-10-06
10198956596351CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-10-06
10198956596702CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-10-06
10198956596726CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-10-06
10198956598362CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-10-06