FDA.reportPublic FDA data

CARDINAL HEALTH

Primary DI
50195594926135
Brand
CARDINAL HEALTH
Company
Cardinal Health 200, LLC
Model
SCVDHIKDU6
Catalog number
SCVDHIKDU6
Device description
INTRODUCER KIT
Published
2021-02-11
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
OFCCatheter introducer kit

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OFCCatheter Introducer KitCardiovascular2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
50195594926135PackageGS110In Commercial Distribution
10195594926137PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
5019559492613550195594926135
1019559492613710195594926137

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.

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
10885380152412CARDINAL HEALTHCAX2304BACAX2304BA2017-10-12
10885380152429CARDINAL HEALTHCAX2304BDCAX2304BD2017-10-12
10885380152559CARDINAL HEALTHCAX2330LACAX2330LA2021-10-27
10885380152566CARDINAL HEALTHCAX2330LDCAX2330LD2021-10-27
10885380171109CARDINAL HEALTHCAX1230LACAX1230LA2020-06-21
10885380171116CARDINAL HEALTHCAX1230LDCAX1230LD2020-06-21
10885380171147CARDINAL HEALTHCAX3030LACAX3030LA2020-06-21
10885380171154CARDINAL HEALTHCAX3030LDCAX3030LD2020-06-21
10885380164545CARDINAL HEALTHCAX5030LACAX5030LA2020-03-18
10885380164552CARDINAL HEALTHCAX5030LDCAX5030LD2020-03-18
10198956286306CARDINAL HEALTHSOPOCLRWSHSOPOCLRWSH2026-08-26
10198956330221CARDINAL HEALTHSBA5FLCABBSBA5FLCABB2026-08-26
10198956346246CARDINAL HEALTHSCVHDVPAGCSCVHDVPAGC2026-08-26
10198956373105CARDINAL HEALTHSNE43LMSUBSNE43LMSUB2026-08-26
10198956384330CARDINAL HEALTHSMA45DCWPBSMA45DCWPB2026-08-26
10198956409767CARDINAL HEALTHSEN18EAVBOSEN18EAVBO2026-08-26
10198956417533CARDINAL HEALTHSEY13EPLHMSEY13EPLHM2026-08-26
10198956423633CARDINAL HEALTHPOCGEXBLJPOCGEXBLJ2026-08-26
10198956437746CARDINAL HEALTH38-8433D38-8433D2026-08-26
10198956461048CARDINAL HEALTHSOP18FTSTMSOP18FTSTM2026-08-26

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
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