FDA.reportPublic FDA data

Monoject

Primary DI
10884521139909
Brand
Monoject
Company
Cardinal Health, Inc.
Model
8881610102
Catalog number
8881610102
Device description
Regular Blood Tube Holder,13 mm Diameter
Published
2016-09-24
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
true

Contact Domains#

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
10884521139909PrimaryGS10
20884521139906Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1088452113990910884521139909
2088452113990620884521139906

GMDN Terms#

Term, Definition table
TermDefinition
Needle guardA cap/cover intended to be extended over a used needle (attached to a syringe/autoinjector or not) to prevent accidental needle sticks, typically during removal of the needle. It is typically a plastic housing with appropriate shielding to prevent injury upon application, and is typically disposed of with the needle; it is not the needle cap provided with the needle. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Outer Diameter13Millimeter

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Keep dry;AVOID DIRECT SUNLIGHT

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
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
false
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