Catalog Number

-

Brand Name

Excyte®

Version/Model Number

DUO-MIX

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

January 17, 2019

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

-

Prescription Use (Rx)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

-

Product Code

GLE

Product Code Name

Mixer, Blood Tube

Public Device Record Key

d3e630e0-7b46-48de-b657-14d2cb87d09a

Public Version Date

August 05, 2022

Public Version Number

5

DI Record Publish Date

November 21, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-