FDA.reportPublic FDA data

CARDINAL HEALTH

Primary DI
50885380189775
Brand
CARDINAL HEALTH
Company
Cardinal Health 200, LLC
Model
5558585005
Catalog number
5558585005
Device description
Vascular Tourniquet
Published
2021-11-08
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Product Codes#

Code, Name table
CodeName
OJSTourniquet kit

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OJSTourniquet KitGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
50885380189775PrimaryGS10
10885380189777Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
5088538018977550885380189775
1088538018977710885380189777

GMDN Terms#

Term, Definition table
TermDefinition
Vascular catheterization support/maintenance kit, non-medicatedA collection of non-dedicated devices intended for catheterization support and/or catheter maintenance (e.g., dressing change, catheter flushing) associated with peripheral venous, central venous, and/or arterial catheterization. Primarily intended to be used at the patient’s bedside, the kit includes devices such as: personal protective equipment (PPE), drapes, disinfectant wipes, dressings, needles, syringes, forceps, scissors, scalpel, tourniquets, ultrasound transducer cover, coupling gel, sharps container, and saline solution. Neither the catheter, catheter introduction device, nor pharmaceuticals are included. This is a single-use device.

Regulatory Flags#

DUNS number
961027315
Device count
100
Premarket exempt
true
Lot or batch
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

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00749756799980DeRoyalDEROYAL INDUSTRIES, INC.OJS2023-03-03
00749756799997DeRoyalDEROYAL INDUSTRIES, INC.OJS2023-03-03
00749756800037DeRoyalDEROYAL INDUSTRIES, INC.OJS2023-03-03
00749756832281DeRoyalDEROYAL INDUSTRIES, INC.OJS2023-03-03
50749756799985DeRoyalDEROYAL INDUSTRIES, INC.OJS2023-03-03
50749756799992DeRoyalDEROYAL INDUSTRIES, INC.OJS2023-03-03
50749756800032DeRoyalDEROYAL INDUSTRIES, INC.OJS2023-03-03
50749756832286DeRoyalDEROYAL INDUSTRIES, INC.OJS2023-03-03
00822045000254SAM Bleeding Control KitSAM Medical ProductsOJS2022-09-01
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10822045000251SAM Bleeding Control KitSAM Medical ProductsOJS2022-09-01
10822045000268SAM Bleeding Control KitSAM Medical ProductsOJS2022-09-01
50885380189782CARDINAL HEALTHCardinal Health 200, LLCOJS2021-11-08
10885380189777CARDINAL HEALTHCardinal Health 200, LLCOJS2021-11-08
10885380189784CARDINAL HEALTHCardinal Health 200, LLCOJS2021-11-08
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10851491007507Direct IV Solutions - IV Start KitLynn Medical Instrument Co.OJS2020-04-23
10851491007514Direct IV Solutions - IV Start KitLynn Medical Instrument Co.OJS2020-04-23
10851491007521Direct IV Solutions - IV Start KitLynn Medical Instrument Co.OJS2020-04-23
20884521069098ArgyleCardinal Health, Inc.OJS2019-12-09
20884521069104ArgyleCardinal Health, Inc.OJS2019-12-09
00812277035155CuraplexBOUND TREE MEDICAL, LLCOJS2019-07-01
00815277028356CuraplexBOUND TREE MEDICAL, LLCOJS2018-12-15
00812277033854CuraplexBOUND TREE MEDICAL, LLCOJS2018-12-15
00812277033861CuraplexBOUND TREE MEDICAL, LLCOJS2018-12-15
10884521547094ArgyleCardinal Health, Inc.OJS2018-06-29