FDA.reportPublic FDA data

Argyle

Primary DI
10884521069084
Brand
Argyle
Company
Cardinal Health, Inc.
Model
5558585005
Catalog number
5558585005
Device description
Vascular Touniquet
Published
2017-05-25
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
MDLIMPLANT, TRANSMANDIBULAR
OJSTourniquet Kit

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MDLImplant, TransmandibularDental2
OJSTourniquet KitGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10884521069084PrimaryGS10
20884521069081Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1088452106908410884521069084
2088452106908120884521069081

GMDN Terms#

Term, Definition table
TermDefinition
Arterial/central venous catheterization support/maintenance kitA collection of sterile devices intended to support the catheterization procedure of an artery and/or central vein (large veins of the upper body), and/or to provide ongoing vascular catheter maintenance. It is primarily intended to be used at the patient’s bedside and includes devices intended to support catheter placement and/or or ongoing maintenance (e.g., dressing change, catheter flushing) such as: disposable drapes, disinfectant wipes, dressings, gown, tourniquets, ultrasound system transducer cover, coupling gel, sharps container, syringe, 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
Length5Inch

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00;

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(508)261-8000covidien.udi@covidien.com

Regulatory Flags#

DUNS number
080935429
Device count
100
Premarket exempt
true
Lot or batch
true
Contains natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10884521012301Monoject118030077711803007772016-09-24
10884521018266Monoject897089702016-09-24
10884521022782SharpSafety8512018512012016-09-24
10884521023253Monoject8506SA8506SA2016-09-24
10884521023369Monoject85221R85221R2016-09-24
10884521023482SharpSafety8534SA8534SA2016-09-24
10884521050310Argyle888856080588885608052016-10-06
10884521050747Argyle888856101988885610192016-09-24
10884521050754Argyle888856102788885610272016-09-24
10884521050761Argyle888856103588885610352016-09-24
10884521050778Argyle888856104388885610432016-09-24
10884521050785Argyle888856105088885610502016-09-24
10884521050792Argyle888856106888885610682016-09-24
10884521050808Argyle888856107688885610762016-10-06
10884521050815Argyle888857050788885705072016-09-24
10884521050822Argyle888857051588885705152016-09-24
10884521050839Argyle888857052388885705232016-09-24
10884521050846Argyle888857054988885705492016-09-24
10884521050853Argyle888857055688885705562016-09-24
10884521050877Argyle888857057288885705722016-09-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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50192253062470CARDINAL HEALTHCardinal Health 200, LLCOJS2026-06-25
00619498512027AirCurve 11 ST-ARESMED PTY LTDMDL2026-04-21
00619498512034AirCurve 11 ST-ARESMED PTY LTDMDL2026-04-21
00619498512157AirCurve 11 ST-ARESMED PTY LTDMDL2026-04-21
00195278522313CARESCAPE Canvas Smart DisplayGE Healthcare Finland OyMDL2023-04-19
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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
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50885380189775CARDINAL HEALTHCardinal Health 200, LLCOJS2021-11-08
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10885380189777CARDINAL HEALTHCardinal Health 200, LLCOJS2021-11-08
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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