Catalog Number

-

Brand Name

CO2 Easy

Version/Model Number

562134

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

9ce36d9b-baa3-4804-acca-a9597c6b2676

Public Version Date

June 17, 2022

Public Version Number

4

DI Record Publish Date

October 24, 2015

Package DI Number

20709078621349

Quantity per Package

10

Contains DI Package

00709078621345

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-