FDA.reportPublic FDA data

Argyle

Primary DI
20884521069104
Brand
Argyle
Company
Cardinal Health, Inc.
Model
5558585047
Catalog number
5558585047
Device description
Vascular Tourniquet Retractor
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
20884521069104PrimaryGS10
70884521069109Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
2088452106910420884521069104
7088452106910970884521069109

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
1500
Premarket exempt
true
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10884521190948Kangaroo384500W384500W2017-09-12
10884521190894Kangaroo3844003844002017-08-02
10884521544475Wings67093670932018-06-27
20884521544489Wings67095670952018-06-27
10884521023284Monoject8507SA8507SA2016-09-24
10884521208742Devon31145892311458922018-06-29
20884521154244Monoject8985PG2Y8985PG2Y2017-01-06
20884521513423Kendall8618RC8618RC2017-05-27
20884521706177Kangaroo388105E388105E2017-04-20
20884527016034Devon31145926311459262018-06-29
30884521022533Monoject8997SPG28997SPG22016-09-24
30884521022557Monoject8998SPG28998SPG22016-09-24
30884527016048Devon31145942311459422018-06-29
40884521022417Monoject8932PG28932PG22016-09-24
10884521019119SharpSafety8556H8556H2018-06-27
20884527000125Argyle888825737888882573782016-09-24
20884527000132Argyle888825738688882573862016-09-24
10884527019854Argyle888850103188885010312016-09-24
10884527019922Argyle888850200588885020052016-09-24
10884527019847Argyle888850102388885010232016-09-24

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
50192253062470CARDINAL 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
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
20884521069098ArgyleCardinal Health, Inc.OJS2019-12-09
00812277035155CuraplexBOUND TREE MEDICAL, LLCOJS2019-07-01