FDA.reportPublic FDA data

Monoject

Primary DI
20884521742298
Brand
Monoject
Company
Cardinal Health, Inc.
Model
8881301611
Catalog number
8881301611
Device description
True content to be populated as part of rebranding
Published
2019-05-17
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
GIMTubes, vacuum sample, with anticoagulant

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GIMTubes, Vacuum Sample, With AnticoagulantClinical Chemistry2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20884521742298PackageGS110In Commercial Distribution
10884521742291PrimaryGS10
30884527002911Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
2088452174229820884521742298
1088452174229110884521742291
3088452700291130884527002911

GMDN Terms#

Term, Definition table
TermDefinition
Non-evacuated blood collection tube IVD, no additiveA non-evacuated sterile glass or plastic tube, sealed with a stopper, containing no additive and intended to be used for the collection, and preservation and/or transport, of blood for analysis and/or other investigation. This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
080935429
Device count
100
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10884527009954Kendall30781747307817472018-06-23
30884527004748Kendall5000736150007361-2016-09-24
10884521021105MonojectSC5008XSC5008X2016-10-20
10884521021112MonojectSC6011XSC6011X2016-10-20
20884521152066Devon31145660311456602016-09-24
20884521152073Devon31145678311456782016-09-24
20884521152080Devon31145686311456862016-09-24
20884521152097Devon31145694311456942016-09-24
20884521152103Devon31145702311457022016-09-24
20884521152110Devon31145710311457102016-09-24
20884521152127Devon31145728311457282016-09-24
20884527020529Argyle888816035888881603582016-09-28
10884521000711Argyle888875001888887500182016-09-24
10884521000735Argyle888875051388887505132016-09-24
10884521011502Kangaroo888474121288847412122016-09-24
10884521011519Kangaroo888474121588847412152016-09-24
10884521011526Kangaroo888474122088847412202016-10-20
10884521011533Kangaroo888474122588847412252016-09-24
10884521011557Kangaroo888474123588847412352016-09-24
10884521011595Kangaroo888474164988847416492016-09-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00382903666171BD MiniDraw Finger Sizing ToolBabson Diagnostics, Inc.GIM2025-12-09
50197106953431CARDINAL HEALTHCardinal Health 200, LLCGIM2025-03-28
10192253051216CovidienCardinal Health 200, LLCGIM2025-01-14
50192253051184MonojectCardinal Health 200, LLCGIM2024-10-08
00382903666188BD MiniDraw™ Cap Removal ToolBECTON, DICKINSON AND COMPANYGIM2024-06-06
30382903666035BD MiniDraw™ H&H Capillary Blood Collection TubeBECTON, DICKINSON AND COMPANYGIM2024-06-06
30382903666134BD MiniDraw™ Finger Sleeve, SmallBECTON, DICKINSON AND COMPANYGIM2024-06-06
30382903666158BD MiniDraw™ Finger Sleeve, LargeBECTON, DICKINSON AND COMPANYGIM2024-06-06
30382903666165BD MiniDraw™ Finger Sleeve, Extra-LargeBECTON, DICKINSON AND COMPANYGIM2024-06-06
30382903666172BD MiniDraw™ Finger Sizing ToolBECTON, DICKINSON AND COMPANYGIM2024-06-06
00382903666195BD MiniDraw™ Capillary Tube Adapter H&HBECTON, DICKINSON AND COMPANYGIM2024-06-06
50192253050927MonojectCardinal Health 200, LLCGIM2024-02-28
50192253050941MonojectCardinal Health 200, LLCGIM2024-02-28
50192253050972MonojectCardinal Health 200, LLCGIM2024-02-28
50192253050996MonojectCardinal Health 200, LLCGIM2024-02-28
50192253051009MonojectCardinal Health 200, LLCGIM2024-02-28
50192253051016MonojectCardinal Health 200, LLCGIM2024-02-28
50192253051023MonojectCardinal Health 200, LLCGIM2024-02-28
50192253051030MonojectCardinal Health 200, LLCGIM2024-02-28
50192253051054MonojectCardinal Health 200, LLCGIM2024-02-28
50192253051061MonojectCardinal Health 200, LLCGIM2024-02-28
50192253051078MonojectCardinal Health 200, LLCGIM2024-02-28
50192253051085MonojectCardinal Health 200, LLCGIM2024-02-28
50192253051108MonojectCardinal Health 200, LLCGIM2024-02-28
39120017579374VacuetteGreiner Bio-One GmbHGIM2023-12-15
15060531711600TransFix/EDTA Vacuum Blood Collection TubeCALTAG MEDSYSTEMS LIMITEDGIM2023-06-20
39120017574751VacuetteGreiner Bio-One GmbHGIM2021-05-07
03573026616694BACT/ALERT®BIOMERIEUX , INC.GIM2020-04-17
20884521742373MonojectCardinal Health, Inc.GIM2019-11-06
20884521742380MonojectCardinal Health, Inc.GIM2019-11-06