FDA.reportPublic FDA data

CARDINAL HEALTH

Primary DI
10197106093665
Brand
CARDINAL HEALTH
Company
Cardinal Health 200, LLC
Model
SCVDHIKD11
Catalog number
SCVDHIKD11
Device description
INTRODUCER PACK
Published
2023-01-09
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
OFCCatheter introducer kit

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OFCCatheter Introducer KitCardiovascular2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
50197106093663PackageGS110In Commercial Distribution
10197106093665PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
5019710609366350197106093663
1019710609366510197106093665

GMDN Terms#

Term, Definition table
TermDefinition
Cardiothoracic surgical procedure kit, non-medicated, single-useA collection of various sterile cardiothoracic surgical instruments, dressings, and materials intended to be used to assist a range of cardiothoracic surgical procedures; it does not contain pharmaceuticals. 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.

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
10885380213281CARDINAL HEALTHCAH4403CAH44032026-05-27
10192253047486Telfa766776672025-09-08
50885380140233CONVERTORS8337N8337N2018-08-20
10192253047967Kendall92339233-2026-05-26
20192253019992Kendall33547T33547T--2026-05-26
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
10198956328457CARDINAL HEALTHPG4ETRHTCPG4ETRHTC2026-05-25
10198956340435CARDINAL HEALTH08-4609B08-4609B2026-05-25
10198956345645CARDINAL HEALTHSEYCGVPCPHSEYCGVPCPH2026-05-25
10198956348189CARDINAL HEALTHSBA48PPNSESBA48PPNSE2026-05-25
10198956350205CARDINAL HEALTHORC431774CORC431774C2026-05-25

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10198956349537CARDINAL HEALTHCardinal Health 200, LLCOFC2026-02-20
50198956349535CARDINAL HEALTHCardinal Health 200, LLCOFC2026-02-20
00850001105125Prytime Medical Devices, Inc.Prytime Medical Devices, Inc.OFC2024-10-16
B090LRKIT0Landmark Catheter Introducer KitZIEN MEDICAL TECHNOLOGIES, INC.OFC2024-04-24
B090LRKIT1Landmark Catheter Introducer KitZIEN MEDICAL TECHNOLOGIES, INC.OFC2024-04-24
10197106117118CARDINAL HEALTHCardinal Health 200, LLCOFC2023-02-03
50197106117116CARDINAL HEALTHCardinal Health 200, LLCOFC2023-02-03
10197106080092CARDINAL HEALTHCardinal Health 200, LLCOFC2023-01-03
00863092000101Prytime Medical Devices, Inc.Prytime Medical Devices, Inc.OFC2022-12-15
10195594801823CARDINAL HEALTHCardinal Health 200, LLCOFC2022-11-09
50195594801821CARDINAL HEALTHCardinal Health 200, LLCOFC2022-11-09
10195594759643CARDINAL HEALTHCardinal Health 200, LLCOFC2022-07-25
50195594759641CARDINAL HEALTHCardinal Health 200, LLCOFC2022-07-25
10195594498221CARDINAL HEALTHCardinal Health 200, LLCOFC2022-01-04
50195594498229CARDINAL HEALTHCardinal Health 200, LLCOFC2022-01-04
10195594958237CARDINAL HEALTHCardinal Health 200, LLCOFC2021-03-08
50195594958235CARDINAL HEALTHCardinal Health 200, LLCOFC2021-03-08
10195594926137CARDINAL HEALTHCardinal Health 200, LLCOFC2021-02-11
50195594926135CARDINAL HEALTHCardinal Health 200, LLCOFC2021-02-11
10888439821550CARDINAL HEALTHCardinal Health 200, LLCOFC2020-04-24
50888439821558CARDINAL HEALTHCardinal Health 200, LLCOFC2020-04-24
10888439783827CARDINAL HEALTHCardinal Health 200, LLCOFC2020-03-24
50888439783825CARDINAL HEALTHCardinal Health 200, LLCOFC2020-03-24
10888439448115CARDINAL HEALTHCardinal Health 200, LLCOFC2019-04-08
50888439448113CARDINAL HEALTHCardinal Health 200, LLCOFC2019-04-08
10888439400151CARDINAL HEALTHCardinal Health 200, LLCOFC2019-03-01
50888439400159CARDINAL HEALTHCardinal Health 200, LLCOFC2019-03-01
10888439076431CARDINAL HEALTHCardinal Health 200, LLCOFC2018-08-01
08714729784432Percutaneous Tract KitBOSTON SCIENTIFIC CORPORATIONOFC2017-09-24
10887488724782CARDINAL HEALTHCardinal Health 200, LLCOFC2017-05-17