Catalog Number

-

Brand Name

Microstream

Version/Model Number

012542

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

November 09, 2017

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

K093388,K093388

Product Code

CCK

Product Code Name

Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase

Public Device Record Key

3e8c5dae-73f5-41c9-993e-d7e53a3875ea

Public Version Date

April 28, 2022

Public Version Number

5

DI Record Publish Date

September 25, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-