FDA.reportPublic FDA data

Argyle

Primary DI
20884521069098
Brand
Argyle
Company
Cardinal Health, Inc.
Model
5558585021
Catalog number
5558585021
Device description
Vascular Tourniquet Plug
Published
2019-12-09
Public version status
Update
Distribution status
Not 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
20884521069098PrimaryGS10
70884521069093Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
2088452106909820884521069098
7088452106909370884521069093

GMDN Terms#

Term, Definition table
TermDefinition
Peripheral intravenous catheterization support kitA collection of noninvasive devices intended to prepare and/or dress a peripheral vein intravenous (IV) access site. It typically includes devices such as a tourniquet, disinfected swabs, dressings, tape, gauze, and gloves; neither the IV access device nor pharmaceuticals are included. It may also include short tubing and/or syringe, however it is not intended to directly conduct fluids from an IV administration bag/bottle (i.e., not an IV administration set). This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
080935429
Device count
2500
Premarket exempt
true
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10884521000308Dover20042004-2016-09-24
10884521000681Dover202020202016-09-24
10884521001039Dover20142014-2016-09-24
10884521001053Dover20182018-2016-09-24
10884521001084Dover625662562016-09-24
10884521009455Dover34203420-2016-09-24
10884521009585Dover3450LF3450LF2016-09-24
10884521082403Curity260026002018-06-29
10884521084216Kerlix26719267192018-06-29
10884521158863Kendall2419CD2419CD2018-06-28
10884527020782Curity260126012018-06-29
10884521174917Devon31141206311412062016-09-24
10884527009954Kendall30781747307817472018-06-23
10884521015791Dover888762312588876231252016-09-24
30884527004847KendallES82417ES82417-2016-09-24
20884521152134Covidien3114574431145744-2016-09-24
30884521024841Kendall923692362018-06-30
10884521138247Devon31146891311468912016-09-24
10884521138261Devon31146893311468932016-09-24
10884521154094Devon31146894311468942016-09-24

Other Devices Sharing Product Codes#

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
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
00851491007487Direct IV Solutions - IV Start KitLynn Medical Instrument Co.OJS2020-04-23
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
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