FDA.reportPublic FDA data

CARDINAL HEALTH

Primary DI
50198956169119
Brand
CARDINAL HEALTH
Company
Cardinal Health 200, LLC
Model
SAN4GATN10
Catalog number
SAN4GATN10
Device description
ARTERIOGRAM TRAY
Published
2025-08-18
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
OERAngioscopic valvulotome kit

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OERAngioscopic Valvulotome KitCardiovascular2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
50198956169119PackageGS16In Commercial Distribution
10198956169111PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
5019895616911950198956169119
1019895616911110198956169111

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.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature15 Degrees Celsius30 Degrees Celsius

Sterilization Methods#

Method table
Method

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
10198956487345CARDINAL HEALTHCardinal Health 200, LLCOER2026-05-25
50198956422337CARDINAL HEALTHCardinal Health 200, LLCOER2026-03-23
50198956385182CARDINAL HEALTHCardinal Health 200, LLCOER2026-02-23
50198956341959CARDINAL HEALTHCardinal Health 200, LLCOER2026-02-20
50198956339581CARDINAL HEALTHCardinal Health 200, LLCOER2026-01-26
50198956268522CARDINAL HEALTHCardinal Health 200, LLCOER2025-12-11
50198956160192CARDINAL HEALTHCardinal Health 200, LLCOER2025-08-06
50198956144956CARDINAL HEALTHCardinal Health 200, LLCOER2025-07-16
50198956136654CARDINAL HEALTHCardinal Health 200, LLCOER2025-07-10
50198956110333CARDINAL HEALTHCardinal Health 200, LLCOER2025-07-07
50198956116984CARDINAL HEALTHCardinal Health 200, LLCOER2025-06-23
50198956104363CARDINAL HEALTHCardinal Health 200, LLCOER2025-06-10
50198956093513CARDINAL HEALTHCardinal Health 200, LLCOER2025-06-05
50198956097870CARDINAL HEALTHCardinal Health 200, LLCOER2025-05-29
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50198956011074CARDINAL HEALTHCardinal Health 200, LLCOER2025-03-25
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50197106911844CARDINAL HEALTHCardinal Health 200, LLCOER2025-01-21
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50197106729234CARDINAL HEALTHCardinal Health 200, LLCOER2024-08-23
50197106524396CARDINAL HEALTHCardinal Health 200, LLCOER2024-02-28
50197106523771CARDINAL HEALTHCardinal Health 200, LLCOER2024-01-29
50195594757272CARDINAL HEALTHCardinal Health 200, LLCOER2022-07-21
50195594480477CARDINAL HEALTHCardinal Health 200, LLCOER2021-12-30