Mix2Vial Transfer Device - Mix2Vial™ 20/17mm w/15μm Large Filter-TGW - WEST PHARMA. SERVICES IL, . LTD

Duns Number:600267793

Device Description: Mix2Vial™ 20/17mm w/15μm Large Filter-TGW

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More Product Details

Catalog Number

-

Brand Name

Mix2Vial Transfer Device

Version/Model Number

8074211

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

MRI safety Status

Labeling does not contain MRI Safety Information

Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)

-

Device labeled as "Not made with natural rubber latex"

-

For Single-Use

Yes

Prescription Use (Rx)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K031861,K031861,K031861

Product Code Details

Product Code

LHI

Product Code Name

Set, I.V. Fluid Transfer

Device Record Status

Public Device Record Key

2788dd55-e8aa-49ed-9b14-a24903ada864

Public Version Date

August 09, 2019

Public Version Number

6

DI Record Publish Date

May 01, 2016

Additional Identifiers

Package DI Number

27290108240409

Quantity per Package

4

Contains DI Package

17290108240402

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-

"WEST PHARMA. SERVICES IL, . LTD" Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 96