FDA.reportPublic FDA data

CARDINAL HEALTH

Primary DI
10198956116986
Brand
CARDINAL HEALTH
Company
Cardinal Health 200, LLC
Model
SAN4GATNH7
Catalog number
SAN4GATNH7
Device description
ARTERIOGRAM TRAY
Published
2025-06-23
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
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
50198956116984PackageGS16In Commercial Distribution
10198956116986PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
5019895611698450198956116984
1019895611698610198956116986

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

Regulatory Flags#

DUNS number
961027315
Device count
1
Premarket exempt
true
Kit
true
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10885380184895CARDINAL HEALTH82021820212024-07-25
10885380184901CARDINAL HEALTH82022820222024-07-25
10885380184918CARDINAL HEALTH82023820232024-07-25
10885380184925CARDINAL HEALTH82024820242024-07-25
50885380004818CONVERTORS9423N9423N2016-06-21
50885380009837CONVERTORS29455NA29455NA2016-06-21
50885380016972CONVERTORS29557N29557N2016-06-21
50885380020016CONVERTORS9450N9450N2016-06-21
50885380027916CONVERTORS9441N9441N2016-06-21
50885380030619CONVERTORS29444N29444N2016-06-21
50885380034068CONVERTORS29527N29527N2016-06-21
50885380034402CONVERTORS29559N29559N2016-06-21
50885380036116CONVERTORS9449N9449N2016-06-21
50885380053755CONVERTORS29421NB29421NB2016-06-21
50885380053779CONVERTORS9438NB9438NB2016-06-21
50885380053854CONVERTORS29465NB29465NB2016-06-21
50885380053878CONVERTORS29467NB29467NB2016-06-21
50885380053892CONVERTORS29522NB29522NB2016-06-21
50885380053922CONVERTORS9430NB9430NB2016-06-21
50885380053939CONVERTORS9458NB9458NB2016-06-21

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10198956487345CARDINAL HEALTHCardinal Health 200, LLCOER2026-05-25
10198956454514CARDINAL HEALTHCardinal Health 200, LLCOER2026-04-27
10198956454545CARDINAL HEALTHCardinal Health 200, LLCOER2026-04-15
10198956448421CARDINAL HEALTHCardinal Health 200, LLCOER2026-04-14
10198956422339CARDINAL HEALTHCardinal Health 200, LLCOER2026-03-23
50198956422337CARDINAL HEALTHCardinal Health 200, LLCOER2026-03-23
10198956387522CARDINAL HEALTHCardinal Health 200, LLCOER2026-02-24
10198956385184CARDINAL HEALTHCardinal Health 200, LLCOER2026-02-23
50198956385182CARDINAL HEALTHCardinal Health 200, LLCOER2026-02-23
10198956341951CARDINAL HEALTHCardinal Health 200, LLCOER2026-02-20
50198956341959CARDINAL HEALTHCardinal Health 200, LLCOER2026-02-20
10198956339583CARDINAL HEALTHCardinal Health 200, LLCOER2026-01-26
50198956339581CARDINAL HEALTHCardinal Health 200, LLCOER2026-01-26
10198956268524CARDINAL HEALTHCardinal Health 200, LLCOER2025-12-11
50198956268522CARDINAL HEALTHCardinal Health 200, LLCOER2025-12-11
10198956266599CARDINAL HEALTHCardinal Health 200, LLCOER2025-11-21
10198956248502CARDINAL HEALTHCardinal Health 200, LLCOER2025-10-27
10198956169111CARDINAL HEALTHCardinal Health 200, LLCOER2025-08-18
50198956169119CARDINAL HEALTHCardinal Health 200, LLCOER2025-08-18
10198956160194CARDINAL HEALTHCardinal Health 200, LLCOER2025-08-06
50198956160192CARDINAL HEALTHCardinal Health 200, LLCOER2025-08-06
10198956144958CARDINAL HEALTHCardinal Health 200, LLCOER2025-07-16
50198956144956CARDINAL HEALTHCardinal Health 200, LLCOER2025-07-16
10198956136656CARDINAL HEALTHCardinal Health 200, LLCOER2025-07-10
50198956136654CARDINAL HEALTHCardinal Health 200, LLCOER2025-07-10
10198956110335CARDINAL HEALTHCardinal Health 200, LLCOER2025-07-07
50198956110333CARDINAL HEALTHCardinal Health 200, LLCOER2025-07-07
50198956116984CARDINAL HEALTHCardinal Health 200, LLCOER2025-06-23
10198956104365CARDINAL HEALTHCardinal Health 200, LLCOER2025-06-10
50198956104363CARDINAL HEALTHCardinal Health 200, LLCOER2025-06-10