Duns Number:293959094
Device Description: The iCOquit breath carbon monoxide (CO) monitor is intended for single person use by indiv The iCOquit breath carbon monoxide (CO) monitor is intended for single person use by individuals wanting to measure the amount of CO on their breath in the home environment, as a motivational aid to help them in their attempt to stop smoking. The iCOquit can also be used by healthcare professionals with individuals in smoking cessation programmes and research.
Catalog Number
ICOQUIT
Brand Name
iCO Quit Smokerlyzer
Version/Model Number
iCO Quit
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"
-
For Single-Use
-
Prescription Use (Rx)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K211918
Product Code
CCJ
Product Code Name
Analyzer, Gas, Carbon-Monoxide, Gaseous-Phase
Public Device Record Key
8e190197-cf78-45e8-9325-e8875c45f37f
Public Version Date
January 14, 2022
Public Version Number
1
DI Record Publish Date
January 06, 2022
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 1 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 5 |