AccessGUDID - DEVICE: iCO Quit Smokerlyzer (05060246860429)

GUDID

Device Identifier (DI) Information

Brand Name: iCO Quit Smokerlyzer
Version or Model: iCO Quit
Commercial Distribution Status: In Commercial Distribution
Catalog Number: ICOQUIT
Company Name: BEDFONT SCIENTIFIC LIMITED

Primary DI Number: 05060246860429
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 293959094 *Terms of Use

Device Description: 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.

Device Characteristics

What MRI safety information does the labeling contain?	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):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	No
Prescription Use (Rx):	No
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
35467	Carbon monoxide breath analyser	An electronic device intended to be used in a clinical setting to measure the concentration of carbon monoxide (CO) in a gas-mixture sample, exhaled by a patient, using a particular method (e.g., electrochemical, infrared spectroscopy, gas chromatography). It may be used to aid in determining the patient's ventilatory status (typically the lung diffusing capacity), or for determining exhaled CO levels (e.g., during jaundice screening in newborns, or in smoking cessation programs); it may also have the capacity to measure the concentration of CO in the atmosphere.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
CCJ	Analyzer, Gas, Carbon-Monoxide, Gaseous-Phase

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K211918	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

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