FDA.reportPublic FDA data

Mixject (TM) with spray head

Primary DI
07290108240931
Brand
Mixject (TM) with spray head
Company
WEST PHARMA. SERVICES IL, . LTD
Model
9070113
Device description
MIXJECT 20mm w/Spray Head
Published
2016-05-01
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
FMFSyringe, Piston

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FMFSyringe, PistonGeneral Hospital2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
27290108240935PackageGS1300Not in Commercial Distribution
07290108240931PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
2729010824093527290108240935
07290108240931072901082409317290108240931

GMDN Terms#

Term, Definition table
TermDefinition
Fluid transfer set, general-purposeA collection of devices and supplies designed to transfer several types of medical fluids (e.g., drugs, vaccines, blood, and solutions) between a first container(s) [e.g., a vial(s)] and a second container [e.g., an intravenous (IV) bag]; it is not dedicated to a particular type of fluid or clinical procedure. It is available in a variety of configurations and typically includes tubes, connectors, spike(s), syringes, and caps. This is a single-use device.

Sterilization Methods#

Method table
Method
Radiation Sterilization

Regulatory Flags#

DUNS number
600267793
Device count
1
Lot or batch
true
Expiration date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
07290108241518Vial2Bag Advanced 20mm Admixture Device60700312026-03-17
07290108241334Vented Vial Adapter Transfer Device807305180730512022-11-23
07290108240238Vial Adapter 15mm 80750032018-02-08
07290108241013MIXJECT9701132016-05-01
07290108240009Vial Adapter80720282016-05-01
07290108241433Vial2Bag Advanced® 13mm Admixture Device607003460700342024-06-23
17290108241430Vial2Bag Advanced® 13mm Admixture Device607003460700342024-06-23
07290108240900ID Adapter50702042016-11-18
07290108240368Vented Vial Adapter Transfer Device80730172016-05-01
07290108240108Swabable Vented Vial Adapter80730092016-05-01
07290108240160Vial Adaptor80703012016-05-01
07290108240276Vial Adaptor80721202016-05-01
07290108240733Vial Adaptor80721162016-05-01
07290108240740Swabable Vented Vial Adapter80730112016-05-01
07290108240917Swabable Vented Vial Adapter80730212016-05-01
07290108240924Vial Adapter80701122016-05-01
07290108241044MIXJECT90701152016-05-01
07290108240771Mix2Vial 20/20mm80740292023-06-15
07290108241099Vial Adapter 20mm with silicon80000162023-06-15
07290108241105VA 13mm with Silicon80703142023-06-15

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10816336022275NC600300-ENFNEOCHILD, LLCFMF2026-07-23
10816336022282NC602000-ENFNEOCHILD, LLCFMF2026-07-23
10816336022442NC600100-ENFNEOCHILD, LLCFMF2026-07-23
00884450492888Merit Medical®Merit Medical Systems, Inc.FMF2026-07-22
10383017593015Ultra-Fine SAFETYEmbecta Medical II, LLCFMF2026-07-21
10383017593213Ultra-Fine SAFETYEmbecta Medical II, LLCFMF2026-07-21
10383017593411Ultra-Fine SAFETYEmbecta Medical II, LLCFMF2026-07-21
10383017593510Ultra-Fine SAFETYEmbecta Medical II, LLCFMF2026-07-21
10383017593718Ultra-Fine SAFETYEmbecta Medical II, LLCFMF2026-07-21
10383017844612Ultra-Fine SAFETYEmbecta Medical II, LLCFMF2026-07-21
10383017844711Ultra-Fine SAFETYEmbecta Medical II, LLCFMF2026-07-21
10383017844919Ultra-Fine SAFETYEmbecta Medical II, LLCFMF2026-07-21
18257200121076O-GENESISOrthofix US LLCFMF2026-07-17
18257200121083O-GENESISOrthofix US LLCFMF2026-07-17
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