FDA.reportPublic FDA data

CoSense Precision Sampling Set

Primary DI
00858481006055
Brand
CoSense Precision Sampling Set
Company
Capnia, INC.
Model
C20206
Device description
The Precision Sampling Set is a single use microfluidic sampling set (nasal cannula). To ensure a valid sampling set is used, when the Precision Sampling Set is connected to the Monitor, there is an electronic handshake between it and the CoSense Monitor. Note: The CoSense Monitor is a reusable electrical medical device with integrated software used in conjunction with a precision sampling set to collect a breath sample from the patient and measure the end tidal carbon monoxide in exhaled breath. The device is non-sterile. No reprocessing is required between uses.
Published
2026-05-06
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Contact Domains#

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
K121768000
K130036000
K151107000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K121768000COSENSECapnia, Inc.2012-10-31CCJ
K130036000COSENSE CO MONITORCapnia, Inc.2014-01-14CCJ
K151107000CoSense ETCO MonitorCapnia, Inc.2015-07-22CCJ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00858481006062PackageGS120In Commercial Distribution
00858481006079PackageGS14In Commercial Distribution
00858481006055PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00858481006062008584810060628584810060620858481006062
00858481006079008584810060798584810060790858481006079
00858481006055008584810060558584810060550858481006055

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.

Contacts#

Phone, Email table
PhoneEmail
8664323788ed.baumann@Capnia.com

Regulatory Flags#

DUNS number
080371374
Device count
1
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00858481006024CO Sensor ModuleC203022026-05-06
00858481006017CoSense ETCO MonitorC201122016-10-14

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00858481006024CO Sensor ModuleCapnia, INC.CCJ2026-05-06
05060246860238D-Piece™BEDFONT SCIENTIFIC LIMITEDCCJ2026-03-17
05060246860474SteriBreath™ EcoBEDFONT SCIENTIFIC LIMITEDCCJ2026-03-17
14250892908929JaegerJaeger Medical GmbHCCJ2025-11-24
05060246860429iCO Quit SmokerlyzerBEDFONT SCIENTIFIC LIMITEDCCJ2022-01-06
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