Mix2Vial Transfer Device - M2V 20/20mm w/15mic large filter TG S- Spike - WEST PHARMA. SERVICES IL, . LTD

Duns Number:600267793

Device Description: M2V 20/20mm w/15mic large filter TG S- Spike

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More Product Details

Catalog Number

-

Brand Name

Mix2Vial Transfer Device

Version/Model Number

8074013

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

8fd33ac1-8de9-4330-9d76-f3667c4aea56

Public Version Date

August 09, 2019

Public Version Number

6

DI Record Publish Date

May 01, 2016

Additional Identifiers

Package DI Number

27290108240263

Quantity per Package

4

Contains DI Package

17290108240266

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