Catalog Number

-

Brand Name

Carbon Monoxide Breath Sensor

Version/Model Number

FP-20021

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

April 30, 2019

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"

-

For Single-Use

-

Prescription Use (Rx)

-

Over the Counter (OTC)

Yes

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K171408

Product Code

CCJ

Product Code Name

Analyzer, Gas, Carbon-Monoxide, Gaseous-Phase

Public Device Record Key

0c7b71fd-2c30-4d31-9cfe-04fa087f8b8d

Public Version Date

December 17, 2019

Public Version Number

5

DI Record Publish Date

October 27, 2017

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-