FDA.reportPublic FDA data

Monoject

Primary DI
10884527004256
Brand
Monoject
Company
Cardinal Health, Inc.
Model
1270019404
Catalog number
1270019404
Device description
Bouchon encliquete pour tubes de 16 mm,Yellow
Published
2018-06-29
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
true
Sterile
false
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
LXGEQUIPMENT, LABORATORY, GENERAL PURPOSE, LABELED OR PROMOTED FOR A SPECIFIC MEDICAL USE

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LXGEquipment, Laboratory, General Purpose, Labeled Or Promoted For A Specific Medical UseClinical Chemistry1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10884527004256PackageGS110000In Commercial Distribution
20884527004253PrimaryGS10
30884527004250Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1088452700425610884527004256
2088452700425320884527004253
3088452700425030884527004250

GMDN Terms#

Term, Definition table
TermDefinition
Medication transfer setA collection of sterile devices and supplies designed to transfer parenteral medications, and sometimes intravenous (IV) fluids, between a first container(s) [e.g., a vial(s)] and a second container [e.g., an intravenous (IV) bag]; it may also be used to reconstitute medication for its preparation and administration. It is available in a variety of configurations and typically includes tubes, connectors, spike(s), syringes, and caps. This is a single-use device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00No;

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
080935429
Device count
1000
DM exempt
false
Premarket exempt
true
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
08435389830269HEATING OVEN H-PLUSBIOTECHNOLOGY INSTITUTE SLLXG2026-01-30
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04250317501578PrefilterChromsystems Instruments + Chemicals GmbHLXG2026-01-22
04250317536204PrefilterChromsystems Instruments + Chemicals GmbHLXG2026-01-22
04250317537577PrefilterChromsystems Instruments + Chemicals GmbHLXG2026-01-22
04250317554611PrecolumnChromsystems Instruments + Chemicals GmbHLXG2026-01-22
04250317555281PrefilterChromsystems Instruments + Chemicals GmbHLXG2026-01-22
04250317558022PrefilterChromsystems Instruments + Chemicals GmbHLXG2026-01-22
09120123910015Anchor Tips, 300uLSTRATEC Consumables GmbHLXG2026-01-14
09120123911012Stackable Cuvette, 1mLSTRATEC Consumables GmbHLXG2026-01-14
06979203760025Chiwell BiotechnologyNingbo Chiwell Biotechnology Co., LtdLXG2025-12-29
06979203760032Chiwell BiotechnologyNingbo Chiwell Biotechnology Co., LtdLXG2025-12-29
06979203760049Chiwell BiotechnologyNingbo Chiwell Biotechnology Co., LtdLXG2025-12-29
06979203760056Chiwell BiotechnologyNingbo Chiwell Biotechnology Co., LtdLXG2025-12-29
06979203760018Chiwell BiotechnologyNingbo Chiwell Biotechnology Co., LtdLXG2025-12-08
04049016152101Reagent tray for incubation of slidesEUROIMMUN Medizinische Labordiagnostika AGLXG2025-11-27
04049016152125Reagent tray for incubation of slidesEUROIMMUN Medizinische Labordiagnostika AGLXG2025-11-27
04250317510174TubeChromsystems Instruments + Chemicals GmbHLXG2025-07-31
04260170881090Q-graft control deviceHuman Med AGLXG2025-07-30
04260170881106Q-graft collectorHuman Med AGLXG2025-07-30
14260170881608Q-graft disposable setHuman Med AGLXG2025-07-30
14260170881615Q-graft centrifugation setHuman Med AGLXG2025-07-30
17290020288001CellSHILEDEQUASHIELD MEDICAL LTDLXG2025-07-20
17290020288018CellSHILEDEQUASHIELD MEDICAL LTDLXG2025-07-20
17290020288025CellSHILEDEQUASHIELD MEDICAL LTDLXG2025-07-20
17290020288032CellSHILEDEQUASHIELD MEDICAL LTDLXG2025-07-20
17290020288049CellSHILEDEQUASHIELD MEDICAL LTDLXG2025-07-20
17290020288056CellSHILEDEQUASHIELD MEDICAL LTDLXG2025-07-20
17290020288063CellSHILEDEQUASHIELD MEDICAL LTDLXG2025-07-20
17290020288070CellSHILEDEQUASHIELD MEDICAL LTDLXG2025-07-20