Catalog Number

-

Brand Name

Mix2Vial Transfer Device

Version/Model Number

8074017

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

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

LHI

Product Code Name

Set, I.V. Fluid Transfer

Public Device Record Key

0878444b-bc83-45ee-a645-0e1bc96c7287

Public Version Date

August 09, 2019

Public Version Number

6

DI Record Publish Date

May 01, 2016

Package DI Number

27290108240539

Quantity per Package

4

Contains DI Package

17290108240532

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-