FDA.reportPublic FDA data

Micro Medical

Primary DI
54250892980145
Brand
Micro Medical
Company
CAREFUSION U.K. 232 LIMITED
Model
36-SC01-STK
Catalog number
36-SC01-STK
Device description
SmokeCheck
Published
2016-09-26
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
54250892980145PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
5425089298014554250892980145

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.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Humidity30 Percent (%) Relative Humidity90 Percent (%) Relative Humidity
Storage Environment Temperature-20 Degrees Celsius70 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+499314972127support.rt.eu@carefusion.com

Regulatory Flags#

DUNS number
291555621
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
34250892980196Micro Medical36-SST100036-SST10002017-04-06
34250892980202Micro Medical36-SST125036-SST12502017-04-06
34250892980219Micro Medical36-PSA100036-PSA10002017-04-06
34250892980226Micro Medical36-PSA120036-PSA12002017-04-06
54250892980022Micro Medical36-MD03-STK36-MD03-STK2016-08-04
54250892980039Micro Medical36-ML2525-STK36-ML2525-STK2016-08-04
54250892980046Micro Medical36-ML3500 MK8-STK36-ML3500 MK8-STK2016-08-04
54250892980053Micro Medical36-ML3500 MK8-REGION 2&336-ML3500 MK8-REGION 2&32016-08-04
54250892980060Micro Medical36-ML3500 MK8-REGION436-ML3500 MK8-REGION42016-08-04
54250892980077Micro Medical36-ML3535 MK8-STK36-ML3535 MK8-STK2016-08-04
54250892980084Micro Medical36-PL10-STK/NHANES36-PL10-STK/NHANES2016-08-04
54250892980091Micro Medical36-ML3535 MK8-REGION 2&336-ML3535 MK8-REGION 2&32016-08-04
54250892980107Micro Medical36-ML3535 MK8-REGION436-ML3535 MK8-REGION42016-08-04
54250892980114Micro Medical36-MS10-STK36-MS10-STK2016-08-04
54250892980121Micro Medical36-PL10-STK/ECCS36-PL10-STK/ECCS2016-08-04
54250892980152Micro Medical36-PL10-STK/ASIAN36-PL10-STK/ASIAN2016-08-04
14250892980185Micro Medical36-MTH641036-MTH64102017-04-06
34250892980233Spirometry PC Software2.536-SPC1000-STK2017-10-27
34250892980257Spirometry PC Software Licence2.536-SPC0105-STK2017-10-27
34250892980264Spirometry PC Software Update2.536-SPCU100-STK2017-10-27

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
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