FDA.reportPublic FDA data

CARDINAL HEALTH

Primary DI
50198956268522
Brand
CARDINAL HEALTH
Company
Cardinal Health 200, LLC
Model
SAN4JATCBC
Catalog number
SAN4JATCBC
Device description
PK ARTERIOGRAM CB
Published
2025-12-11
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
50198956268522PackageGS12In Commercial Distribution
10198956268524PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
5019895626852250198956268522
1019895626852410198956268524

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.

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
50198956169119CARDINAL HEALTHCardinal Health 200, LLCOER2025-08-18
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
50198956073508CARDINAL HEALTHCardinal Health 200, LLCOER2025-05-09
50198956061284CARDINAL HEALTHCardinal Health 200, LLCOER2025-04-23
50198956011074CARDINAL HEALTHCardinal Health 200, LLCOER2025-03-25
50198956012156CARDINAL HEALTHCardinal Health 200, LLCOER2025-03-25
50198956016987CARDINAL HEALTHCardinal Health 200, LLCOER2025-03-25
50197106963126CARDINAL HEALTHCardinal Health 200, LLCOER2025-03-11
50197106970254CARDINAL HEALTHCardinal Health 200, LLCOER2025-02-28
50197106949489CARDINAL HEALTHCardinal Health 200, LLCOER2025-02-13
50197106911844CARDINAL HEALTHCardinal Health 200, LLCOER2025-01-21
50197106912766CARDINAL HEALTHCardinal Health 200, LLCOER2025-01-21
50197106779888CARDINAL HEALTHCardinal Health 200, LLCOER2024-10-29
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