Catalog Number

-

Brand Name

Microstream

Version/Model Number

012521_RMS1

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

MRI safety Status

MR Safe

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"

Yes

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,K093388

Product Code

CCK

Product Code Name

Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase

Public Device Record Key

506eae3f-13fd-4f51-b7f3-c0686e45edbe

Public Version Date

April 22, 2022

Public Version Number

7

DI Record Publish Date

January 11, 2018

Package DI Number

20884521554136

Quantity per Package

100

Contains DI Package

10884521552104

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CASE