Catalog Number

013225

Brand Name

Microstream

Version/Model Number

013225

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

September 04, 2019

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"

-

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

K121927,K121927

Product Code

CCK

Product Code Name

ANALYZER, GAS, CARBON-DIOXIDE, GASEOUS-PHASE

Public Device Record Key

4604d14d-dc3e-43f0-8e08-a03dfae50c52

Public Version Date

August 05, 2022

Public Version Number

6

DI Record Publish Date

November 16, 2017

Package DI Number

10884521619340

Quantity per Package

25

Contains DI Package

10884521619333

Package Discontinue Date

-

Package Status

Not in Commercial Distribution

Package Type

CASE