FDA.reportPublic FDA data

Monoject

Primary DI
50192253050972
Brand
Monoject
Company
Cardinal Health 200, LLC
Model
8881301611
Catalog number
8881301611
Device description
Blood Collection Tube
Published
2024-02-28
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
50192253050972PackageGS110In Commercial Distribution
20192253050971PrimaryGS10
10192253050974Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
5019225305097250192253050972
2019225305097120192253050971
1019225305097410192253050974

GMDN Terms#

Term, Definition table
TermDefinition
Non-evacuated blood collection tube IVD, no additiveA non-evacuated 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
961027315
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
10192253047967Kendall92339233-2026-05-26
20192253017615Medi-Trace Cadence22661PC22661PC2021-07-29
20192253019992Kendall33547T33547T--2026-05-26
20885380136617CARDINAL HEALTHN8830N88302019-02-07
20885380136624CARDINAL HEALTHN8831N88312019-02-07
20885380136631CARDINAL HEALTHN8832N88322019-02-07
20885380168069CARDINAL HEALTHC3660PPLC3660PPL2019-04-30
10192253045093KendallMK00175MK001752023-06-15
10192253013016Argyle888875001888887500182022-10-26
10192253013023Argyle888875051388887505132022-10-26
10198956056497CARDINAL HEALTHPN69MSGADPN69MSGAD2026-05-25
10198956057005CARDINAL HEALTHSBACGDPMEDSBACGDPMED2026-05-25
10198956221161CARDINAL HEALTHSOP29PLCCYSOP29PLCCY2026-05-25
10198956253773CARDINAL HEALTHSOP56TKTCCSOP56TKTCC2026-05-25
10198956257610CARDINAL HEALTHSOPOCTKLHKSOPOCTKLHK2026-05-25
10198956258730CARDINAL HEALTHAMN4Q8277CAMN4Q8277C2026-05-25
10198956291812CARDINAL HEALTHSOP4FKPWFBSOP4FKPWFB2026-05-25
10198956300316CARDINAL HEALTH34-2071H34-2071H2026-05-25
10198956321632CARDINAL HEALTHSOPCGKHAUCSOPCGKHAUC2026-05-25
10198956325487CARDINAL HEALTHPO43LEUNCPO43LEUNC2026-05-25

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
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
20884521742243MonojectCardinal Health, Inc.GIM2019-08-30