FDA.reportPublic FDA data

iCO Quit Smokerlyzer

Primary DI
05060246860429
Brand
iCO Quit Smokerlyzer
Company
BEDFONT SCIENTIFIC LIMITED
Model
iCO Quit
Catalog number
ICOQUIT
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.
Published
2022-01-06
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
CCJAnalyzer, Gas, Carbon-Monoxide, Gaseous-Phase

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
CCJAnalyzer, Gas, Carbon-Monoxide, Gaseous-PhaseAnesthesiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K211918000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K211918000iCOquit® Smokerlyzer®Bedfont Scientific, Ltd.2021-12-21CCJ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05060246860429PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05060246860429050602468604295060246860429

GMDN Terms#

Term, Definition table
TermDefinition
Carbon monoxide breath analyserAn 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.

Regulatory Flags#

DUNS number
293959094
Device count
1
Serial number
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
05060246860238D-Piece™D-Piece™D-PIECE-32026-03-17
05060246860474SteriBreath™ EcoSteriBreath™ Eco MouthpieceSTERIBREATH-ECO2026-03-17
05060246860191NObreath®NObreath® MouthpieceNOBREATH-V2-MP502026-03-09
05060246860368GastrolyzerGastroCHECKGASTROCHECK2024-09-05
05060246860399GastrolyzerGastroGENIUSLMTCH42023-06-15
05060246860108GastrolyzerGastro+GASTRO2023-06-08
05060246860153GastrolyzerHydroGeniusLMTH22023-06-08
05060246860375GastrolyzerGastroCHECKGASTROCEHCK-US2020-03-12
05060246860177NOBreathNOBreath V2NOBREATH-V22022-01-06
05060246860320FeNOBreathFeNOBreathFENOBREATH-MGC2022-01-06
05060246860030ToxCOToxCOTOXCO-USA2020-03-12
05060246860047SmokerlyzerMicro+MICROADV2020-03-12

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00858481006024CO Sensor ModuleCapnia, INC.CCJ2026-05-06
00858481006055CoSense Precision Sampling SetCapnia, INC.CCJ2026-05-06
05060246860238D-Piece™BEDFONT SCIENTIFIC LIMITEDCCJ2026-03-17
05060246860474SteriBreath™ EcoBEDFONT SCIENTIFIC LIMITEDCCJ2026-03-17
14250892908929JaegerJaeger Medical GmbHCCJ2025-11-24
15099169297507BreathCOVITALOGRAPH (IRELAND) LIMITEDCCJ2021-03-11
069364159026741-Slot CO2 Module w/ kit (Neo)Shenzhen Mindray Bio-Medical Electronics Co., Ltd.CCJ2020-05-10
069364159027591-Slot CO2/O2 Module w/ kit (Neo)Shenzhen Mindray Bio-Medical Electronics Co., Ltd.CCJ2020-05-10
06944904098432Sidestream CO2 module(FDA/FJ)IIShenzhen Mindray Bio-Medical Electronics Co., Ltd.CCJ2020-05-10
06944904098449IBP_CO_SidestreamCO2 module(FDA)IIShenzhen Mindray Bio-Medical Electronics Co., Ltd.CCJ2020-05-10
06944904098456IBP_CO_SidestreamCO2 module(FDA/FJ)IIShenzhen Mindray Bio-Medical Electronics Co., Ltd.CCJ2020-05-10
06944904098463Sidestream CO2 module(FDA)IIShenzhen Mindray Bio-Medical Electronics Co., Ltd.CCJ2020-05-10
06944904096803ORIDION CO2 mod upgrd kit,intlShenzhen Mindray Bio-Medical Electronics Co., Ltd.CCJ2020-05-07
06944904096698single CO2 Module(accessory kit)Shenzhen Mindray Bio-Medical Electronics Co., Ltd.CCJ2020-05-06
06944904096759ORIDION CO2(Package/no accessory)Shenzhen Mindray Bio-Medical Electronics Co., Ltd.CCJ2020-05-06
06944904096810single CO2 Module(Neonate accessory kit)Shenzhen Mindray Bio-Medical Electronics Co., Ltd.CCJ2020-05-06
06944904098784115-046935-00Shenzhen Mindray Bio-Medical Electronics Co., Ltd.CCJ2020-05-06
05060246860030ToxCOBEDFONT SCIENTIFIC LIMITEDCCJ2020-03-12
05060246860047SmokerlyzerBEDFONT SCIENTIFIC LIMITEDCCJ2020-03-12
14250892904129VyaireJaeger Medical GmbHCCJ2019-05-28
00863571000318Pivot Breath Sensor CARROT INC. WHICH WILL DO BUSINESS IN CALIFORNIA AS CARROT BEHAVIORAL HEALTH INC.CCJ2019-04-25
08635710003014Pivot Breath Sensor CARROT INC. WHICH WILL DO BUSINESS IN CALIFORNIA AS CARROT BEHAVIORAL HEALTH INC.CCJ2019-04-25
14250892904136VyaireJaeger Medical GmbHCCJ2019-03-19
54250892905506VyaireJaeger Medical GmbHCCJ2019-03-19
14250892901838Micro MedicalJaeger Medical GmbHCCJ2018-05-11
14250892901869Micro MedicalJaeger Medical GmbHCCJ2018-05-11
54250892901362Micro MedicalJaeger Medical GmbHCCJ2018-03-31
54250892901584Micro MedicalJaeger Medical GmbHCCJ2018-03-31
00863571000301Carbon Monoxide Breath Sensor CARROT INC. WHICH WILL DO BUSINESS IN CALIFORNIA AS CARROT BEHAVIORAL HEALTH INC.CCJ2017-10-27
08635710003007Carbon Monoxide Breath Sensor CARROT INC. WHICH WILL DO BUSINESS IN CALIFORNIA AS CARROT BEHAVIORAL HEALTH INC.CCJ2017-10-27