FDA.reportPublic FDA data

CARDINAL HEALTH

Primary DI
10198956488618
Brand
CARDINAL HEALTH
Company
Cardinal Health 200, LLC
Model
SAN69CCE22
Catalog number
SAN69CCE22
Device description
CARDIAC CATH PACK
Published
2026-05-25
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
50198956488616PackageGS12In Commercial Distribution
10198956488618PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
5019895648861650198956488616
1019895648861810198956488618

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
10192253047967Kendall92339233-2026-05-26
20192253017615Medi-Trace Cadence22661PC22661PC2021-07-29
20192253019992Kendall33547T33547T--2026-05-26
20885380136617CARDINAL HEALTHN8830N88302019-02-07
20885380136624CARDINAL HEALTHN8831N88312019-02-07
20885380136631CARDINAL HEALTHN8832N88322019-02-07
20885380168069CARDINAL HEALTHC3660PPLC3660PPL2019-04-30
10192253045093KendallMK00175MK001752023-06-15
10192253013016Argyle888875001888887500182022-10-26
10192253013023Argyle888875051388887505132022-10-26
10198956056497CARDINAL HEALTHPN69MSGADPN69MSGAD2026-05-25
10198956057005CARDINAL HEALTHSBACGDPMEDSBACGDPMED2026-05-25
10198956221161CARDINAL HEALTHSOP29PLCCYSOP29PLCCY2026-05-25
10198956253773CARDINAL HEALTHSOP56TKTCCSOP56TKTCC2026-05-25
10198956257610CARDINAL HEALTHSOPOCTKLHKSOPOCTKLHK2026-05-25
10198956258730CARDINAL HEALTHAMN4Q8277CAMN4Q8277C2026-05-25
10198956291812CARDINAL HEALTHSOP4FKPWFBSOP4FKPWFB2026-05-25
10198956300316CARDINAL HEALTH34-2071H34-2071H2026-05-25
10198956321632CARDINAL HEALTHSOPCGKHAUCSOPCGKHAUC2026-05-25
10198956325487CARDINAL HEALTHPO43LEUNCPO43LEUNC2026-05-25

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10809160521847HalyardAVID MEDICAL, INC.OES2026-05-26
10198956478855CARDINAL HEALTHCardinal Health 200, LLCOES2026-05-25
10198956485457CARDINAL HEALTHCardinal Health 200, LLCOES2026-05-25
10198956486775CARDINAL HEALTHCardinal Health 200, LLCOES2026-05-25
20809160517236HalyardAVID MEDICAL, INC.OES2026-03-24
50198956364194CARDINAL HEALTHCardinal Health 200, LLCOES2026-03-23
50198956380385CARDINAL HEALTHCardinal Health 200, LLCOES2026-03-23
50198956415070CARDINAL HEALTHCardinal Health 200, LLCOES2026-03-23
50198956433234CARDINAL HEALTHCardinal Health 200, LLCOES2026-03-23
20809160517120HalyardAVID MEDICAL, INC.OES2026-03-23
20809160516871HalyardAVID MEDICAL, INC.OES2026-03-20
20809160516895HalyardAVID MEDICAL, INC.OES2026-03-20
20809160516956HalyardAVID MEDICAL, INC.OES2026-03-20
50198956404272CARDINAL HEALTHCardinal Health 200, LLCOES2026-03-19
50198956410518CARDINAL HEALTHCardinal Health 200, LLCOES2026-03-19
50198956412826CARDINAL HEALTHCardinal Health 200, LLCOES2026-03-19
40198459589899MEDLINEMEDLINE INDUSTRIES, INC.OES2026-03-16
40198459594985MEDLINEMEDLINE INDUSTRIES, INC.OES2026-03-16
40198459611538MEDLINEMEDLINE INDUSTRIES, INC.OES2026-03-16
40198459611552MEDLINEMEDLINE INDUSTRIES, INC.OES2026-03-16
40198459611569MEDLINEMEDLINE INDUSTRIES, INC.OES2026-03-16
40198459611576MEDLINEMEDLINE INDUSTRIES, INC.OES2026-03-16
40198459613556MEDLINEMEDLINE INDUSTRIES, INC.OES2026-03-16
40198459616618MEDLINEMEDLINE INDUSTRIES, INC.OES2026-03-16
40198459616625MEDLINEMEDLINE INDUSTRIES, INC.OES2026-03-16
40198459616632MEDLINEMEDLINE INDUSTRIES, INC.OES2026-03-16
40198459616649MEDLINEMEDLINE INDUSTRIES, INC.OES2026-03-16
40198459619466MEDLINEMEDLINE INDUSTRIES, INC.OES2026-03-16
40198459619770MEDLINEMEDLINE INDUSTRIES, INC.OES2026-03-16
40198459620967MEDLINEMEDLINE INDUSTRIES, INC.OES2026-03-16