FDA.reportPublic FDA data

CARDINAL HEALTH

Primary DI
10888439783827
Brand
CARDINAL HEALTH
Company
Cardinal Health 200, LLC
Model
SCVDHIKDU4
Catalog number
SCVDHIKDU4
Device description
INTRODUCER KIT
Published
2020-03-24
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
50888439783825PackageGS110In Commercial Distribution
10888439783827PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
5088843978382550888439783825
1088843978382710888439783827

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
10192253047981Kendall923692362026-06-09
10192253047998Kendall923892382026-06-09
10192253048001Kendall923992392026-06-09
10192253048018Kendall924092402026-06-09
10192253048025Kendall924292422026-06-09
10192253048032Kendall924392432026-06-09
10192253046205Webcol511051102024-09-05
10192253047066Webcol68186818-2025-06-10
10192253047073Webcol6818-16818-12025-07-28
10884521008427Dover502750272016-09-24
10885380052538CARDINAL HEALTHC-CB2SC-CB2S2023-08-07
10885380052545CARDINAL HEALTHC-CB3SC-CB3S2023-08-07
10885380052569CARDINAL HEALTHC-CB6SC-CB6S2023-08-07
10885380052613CARDINAL HEALTHC-CB6C-CB62023-08-07
10885380107801CARDINAL HEALTHABP1201ABP12012016-07-22
10885380107818CARDINAL HEALTHASC1201ASC12012016-07-22
10885380107825CARDINAL HEALTHASC1210ASC12102016-07-22
10885380107832CARDINAL HEALTHASC1211ASC12112016-07-22
10885380107849CARDINAL HEALTHASC1220ASC12202016-07-22
10885380107856CARDINAL HEALTHASC1221ASC12212016-07-22

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
10197106093665CARDINAL HEALTHCardinal Health 200, LLCOFC2023-01-09
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
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