Catalog Number

-

Brand Name

CO2 Sampling Line

Version/Model Number

0500

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

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"

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

-

Product Code

CCK

Product Code Name

Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase

Public Device Record Key

d6c2bcb3-668f-43a6-84a1-9c6efea6a8c5

Public Version Date

March 22, 2022

Public Version Number

2

DI Record Publish Date

February 28, 2020

Package DI Number

10709078008365

Quantity per Package

50

Contains DI Package

00709078008368

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-