FDA.reportPublic FDA data

CARDINAL HEALTH

Primary DI
10198956590229
Brand
CARDINAL HEALTH
Company
Cardinal Health 200, LLC
Model
SAN33HCSFJ
Catalog number
SAN33HCSFJ
Device description
THOMAS HEALTH SYSTEM CATH PACK
Published
2026-10-23
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
50198956590227PackageGS14In Commercial Distribution
10198956590229PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
5019895659022750198956590227
1019895659022910198956590229

GMDN Terms#

Term, Definition table
TermDefinition
Angiography kitA collection of sterile devices and equipment used to prepare a patient for the radiographic visualization of the arteries of a particular organ system or body part through the vascular injection of contrast media. It typically includes a combination of fluid/contrast media administration devices (e.g., tubing, manifold, stopcocks, and syringes) and/or dedicated angiography supportive devices (e.g., angiography drapes, covers, dressings); the angiography catheter is not included. This is a single-use device.

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
10198956106666CARDINAL HEALTHSAN23PMPRHSAN23PMPRH2026-10-23
10198956201606CARDINAL HEALTHPOV2ASNULPOV2ASNUL2026-10-23
10198956318748CARDINAL HEALTHSAN42RPIRBSAN42RPIRB2026-10-23
10198956332553CARDINAL HEALTHPNVNNECHVPNVNNECHV2026-10-23
10198956409552CARDINAL HEALTHSCV40CVKUGSCV40CVKUG2026-10-23
10198956433113CARDINAL HEALTHSEN40EPWEDSEN40EPWED2026-10-23
10198956460942CARDINAL HEALTHSBA69BPSABSBA69BPSAB2026-10-23
10198956463417CARDINAL HEALTHPB41GLLAEPB41GLLAE2026-10-23
10198956487918CARDINAL HEALTHSOPHDTPMSCSOPHDTPMSC2026-10-23
10198956504899CARDINAL HEALTHSNE12CRKGOSNE12CRKGO2026-10-23
10198956505766CARDINAL HEALTHSOPCNARCRESOPCNARCRE2026-10-23
10198956506572CARDINAL HEALTHSOT7ECPSSESOT7ECPSSE2026-10-23
10198956508682CARDINAL HEALTHSOP53TPNABSOP53TPNAB2026-10-23
10198956530157CARDINAL HEALTHSAN11IRLVLSAN11IRLVL2026-10-23
10198956530799CARDINAL HEALTH34-0748B34-0748B2026-10-23
10198956534834CARDINAL HEALTHSANOCCCPOFSANOCCCPOF2026-10-23
10198956544123CARDINAL HEALTHPG08GMPCBPG08GMPCB2026-10-23
10198956548923CARDINAL HEALTHSNE33SPMACSNE33SPMAC2026-10-23
10198956549524CARDINAL HEALTHSBA11LYMMJSBA11LYMMJ2026-10-23
10198956553552CARDINAL HEALTHSOP41TPSGGSOP41TPSGG2026-10-23

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10198956106666CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-10-23
10198956530157CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-10-23
10198956563063CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-10-23
10198956603837CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-10-23
10198956606982CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-10-23
10198956608016CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-10-23
10198956608214CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-10-23
10198956609068CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-10-23
10198956611177CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-10-23
10198956611351CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-10-23
10198956612730CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-10-23
10198956614918CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-10-23
10198956616677CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-10-23
10198956616738CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-10-23
B098AMS188920Aligned Medical SolutionsAligned Medical SolutionsOEQ2026-10-23
B098AMS199310Aligned Medical SolutionsAligned Medical SolutionsOEQ2026-10-23
00884450499214Merit Medical®Merit Medical Systems, Inc.OEQ2026-10-22
00884450501023Merit Medical®Merit Medical Systems, Inc.OEQ2026-10-22
00884450502082Merit Medical®Merit Medical Systems, Inc.OEQ2026-10-22
00884450431641Merit Medical®Merit Medical Systems, Inc.OEQ2026-10-21
10809160541029Medical Action IndustriesMEDICAL ACTION INDUSTRIES INC.OEQ2026-10-21
10198956513587CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-10-19
10198956553422CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-10-19
10198956591677CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-10-19
10198956594395CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-10-19
10198956607712CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-10-19
10198956608641CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-10-19
10198956611320CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-10-19
10198956613294CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-10-19
10198956613522CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-10-19