Catalog Number

-

Brand Name

Neo-StatCO2<Kg End Tidal CO2 Detector

Version/Model Number

10-55373

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

K083056,K083056

Product Code

CCK

Product Code Name

Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase

Public Device Record Key

3e19a101-49b1-42e8-8e7c-ddb5465524e8

Public Version Date

May 18, 2020

Public Version Number

4

DI Record Publish Date

January 08, 2016

Package DI Number

30641043553736

Quantity per Package

20

Contains DI Package

10641043553732

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-