Catalog Number

-

Brand Name

MIXJECT

Version/Model Number

9070126

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

May 01, 2016

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

K963583,K963583,K963583

Product Code

LHI

Product Code Name

Set, I.V. Fluid Transfer

Public Device Record Key

a69df231-0444-4fbd-b495-c00c349d6abc

Public Version Date

January 18, 2022

Public Version Number

6

DI Record Publish Date

May 01, 2016

Package DI Number

27290108241062

Quantity per Package

4

Contains DI Package

17290108241065

Package Discontinue Date

November 23, 2015

Package Status

Not in Commercial Distribution

Package Type

-