FDA.reportPublic FDA data

CARDINAL HEALTH

Primary DI
50192253062470
Brand
CARDINAL HEALTH
Company
Cardinal Health 200, LLC
Model
5558585005
Catalog number
5558585005
Device description
Vascular Tourniquet 5 in. (12.7 cm)
Published
2026-06-25
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
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
50192253062470PrimaryGS10
10192253062472Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
5019225306247050192253062470
1019225306247210192253062472

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.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length0

Regulatory Flags#

DUNS number
961027315
Device count
100
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
true
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10192253004205Monoject1525SA1525SA2026-07-13
10192253004410Monoject8507MW8507MW2026-07-13
10192253004540Monoject8533SA8533SA2026-07-13
10192253004588Monoject8537MW8537MW2026-07-13
10192253004625SharpSafety8540SA8540SA2026-07-13
10192253004885Monoject8900MW8900MW2026-07-13
10192253005127Monoject8979MW8979MW2026-07-13
10192253005509Monoject8525Y8525Y2026-07-13
10192253071894Argyle47802478022026-07-13
20192253017455Kendall31469219314692192021-05-05
20192253017547Medi-Trace Cadence22550A22550A-2021-07-28
20192253017554Medi-Trace Cadence22550P22550P-2021-08-19
20192253017578Medi-Trace Cadence22550PC22550PC2021-07-29
20192253017585Medi-Trace Cadence22550R22550R-2021-07-29
20192253017608Medi-Trace Cadence22660R22660R-2024-02-28
20192253017622Medi-Trace Cadence22770P22770P2021-08-19
20192253017639Medi-Trace Cadence22770PC22770PC2021-07-29
20192253017721Kendall31319281313192812021-05-05
20192253018889Medi-Trace Cadence22770R22770R-2021-07-29
20192253017592Medi-Trace Cadence22660PC22660PC2021-07-29

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10192253062496ArgyleCardinal Health 200, LLCOJS2026-06-25
50192253005781CARDINAL HEALTHCardinal Health 200, LLCOJS2026-06-25
50192253005798CARDINAL HEALTHCardinal Health 200, LLCOJS2026-06-25
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
00822045000261SAM Bleeding Control KitSAM Medical ProductsOJS2022-09-01
10822045000251SAM Bleeding Control KitSAM Medical ProductsOJS2022-09-01
10822045000268SAM Bleeding Control KitSAM Medical ProductsOJS2022-09-01
50885380189775CARDINAL HEALTHCardinal Health 200, LLCOJS2021-11-08
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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00851491007500Direct IV Solutions - IV Start KitLynn Medical Instrument Co.OJS2020-04-23
00851491007517Direct IV Solutions - IV Start KitLynn Medical Instrument Co.OJS2020-04-23
00851491007524Direct IV Solutions - IV Start KitLynn Medical Instrument Co.OJS2020-04-23
20851491007481Direct IV Solutions - IV Start KitLynn Medical Instrument Co.OJS2020-04-23
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