FDA.reportPublic FDA data

Mix2Vial Transfer Device

Primary DI
07290108240382
Brand
Mix2Vial Transfer Device
Company
WEST PHARMA. SERVICES IL, . LTD
Model
8074020
Device description
Mix2Vial 20/20mm 5mic filter TG S- Spike
Published
2016-05-01
Public version status
Update
Distribution status
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
LHISet, I.V. Fluid Transfer

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LHISet, I.V. Fluid TransferGeneral Hospital2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K031861000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K031861000MIX2VIAL TRANSFER DEVICEMedimop Medical Projects, Ltd.2003-07-29LHI

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
17290108240389PackageGS175In Commercial Distribution
27290108240386PackageGS14In Commercial Distribution
07290108240382PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1729010824038917290108240389
2729010824038627290108240386
07290108240382072901082403827290108240382

GMDN Terms#

Term, Definition table
TermDefinition
Medication transfer needle, filteringA slender, rigid, sharp or blunt tube intended to be attached to a syringe and typically used in the pharmacy to aspirate and transfer fluid medication from a vial/ampule to another container for medication preparation or other purposes. It includes an integral filter (e.g., a microporous stainless steel filter) intended to retain micro-particles from the drug as it flows through the needle to reduce the risk of particle contamination of the patient medication; it does not include a back-pressure venting feature. 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
07290108240931Mixject (TM) with spray head90701132016-05-01
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

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