No | Primary DI | Version or Model | Catalog Number | Device Description | Product Code | Product Code Name | Device Class | Brand Name |
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1 | 05060246860320 | FeNOBreath | FENOBREATH-MGC | The FeNObreath is a portable, non-invasive device for the measurement of Fractio The FeNObreath is a portable, non-invasive device for the measurement of Fractional Exhaled Nitric Oxide (FeNO) in human breath. The production of nitric oxide is often found to be increased in inflammatory conditions such as asthma. Measurement of FeNO by FeNObreath is a method to measure the decrease in FeNO concentration in asthma patients that often occurs after treatment with anti-inflammatory pharmacological therapy, as an indication of the therapeutic effect in patients with elevated FeNO levels.The fractional NO concentration in expired breath (FeNO), can be measured by FeNObreath according to guidelines for NO measurement established by the American Thoracic Society.FeNObreath is intended for children, 7- 17 years, and adults 18 years and older. FeNObreath 12 second test mode is for age 7 and upFeNObreath 10 second test mode is for ages 7-10 only who cannot successfully complete a 12 second test.FeNO measurements provide the physician with means of evaluating an asthma patient's response to anti-inflammatory therapy, as an adjunct to the established clinical and laboratory assessments in asthma. The FeNObreath cannot be used with infants or by children under the age of 7 as measurement requires patient cooperation.FeNObreath should not be used in critical care, emergency care or in anesthesiology. | MXA | System, Test, Breath Nitric Oxide | 2 | FeNOBreath |
2 | 05060246860047 | Micro+ | MICROADV | The Micro+™ Smokerlyzer® product is a breath carbon monoxide monitor intended fo The Micro+™ Smokerlyzer® product is a breath carbon monoxide monitor intended for multi-patient use by healthcare professionals in smoking cessation programmes and research. The Micro+™ Smokerlyzer® product can also be used as an indicator of carbon monoxide poisoning in a healthcare environment. | CCJ | Analyzer, Gas, Carbon-Monoxide, Gaseous-Phase | 2 | Smokerlyzer |
3 | 05060246860177 | NOBreath V2 | NOBREATH-V2 | The NObreath® is a portable, non-invasive device for the measurement of Fraction The NObreath® is a portable, non-invasive device for the measurement of Fractional Exhaled Nitric Oxide (FeNO) in human breath. The production of nitric oxide is often found to be increased in inflammatory conditions such as asthma. Measurement of FeNO by NObreath® is a method to measure the decrease in FeNO concentration in asthma patients that often occurs after treatment with anti-inflammatory pharmacological therapy, as an indication of the therapeutic effect in patients with elevated FeNO levels.The fractional NO concentration in expired breath (FeNO), can be measured by NObreath® according to guidelines for NO measurement established by the American Thoracic Society.NObreath® is intended for children, 7- 17 years, and adults 18 years and older. NObreath® 12 second test mode is for age 7 and upNObreath® 10 second test mode is for ages 7-10 only who cannot successfully complete a 12 second test.FeNO measurements provide the physician with means of evaluating an asthma patient's response to anti-inflammatory therapy, as an adjunct to the established clinical and laboratory assessments in asthma. The NObreath® cannot be used with infants or by children under the age of 7 as measurement requires patient cooperation.NObreath® should not be used in critical care, emergency care or in anesthesiology. | MXA | System, Test, Breath Nitric Oxide | 2 | NOBreath |
4 | 05060246860030 | ToxCO | TOXCO-USA | The ToxCO Breath Carbon Monoxide Monitor is used in the screening of Carbon Mono The ToxCO Breath Carbon Monoxide Monitor is used in the screening of Carbon Monoxide (CO) poisoning and calculation of the Carboxyhaemoglobin (COHb) level. The ToxCO Breath Carbon Monoxide Monitor can be used by healthcare professionals in medical institutions, emergency medical services where Carbon Monoxide exposure is suspected for paediatric, adult, and unconscious patients. | CCJ | Analyzer, Gas, Carbon-Monoxide, Gaseous-Phase | 2 | ToxCO |
5 | 05060246860375 | GastroCHECK | GASTROCEHCK-US | Measurement of Hydrogen, Methane and Oxygen levels in the exhaled breath. | LXG | Equipment, Laboratory, General Purpose, Labeled Or Promoted For A Specific Medical Use | 1 | Gastrolyzer |
No | Primary DI | Version or Model | Catalog Number | Device Description | Brand Name | Organization Name |
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1 | 05060246860429 | iCO Quit | ICOQUIT | The iCOquit breath carbon monoxide (CO) monitor is intended for single person us 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. | iCO Quit Smokerlyzer | BEDFONT SCIENTIFIC LIMITED |
2 | 05060246860047 | Micro+ | MICROADV | The Micro+™ Smokerlyzer® product is a breath carbon monoxide monitor intended fo The Micro+™ Smokerlyzer® product is a breath carbon monoxide monitor intended for multi-patient use by healthcare professionals in smoking cessation programmes and research. The Micro+™ Smokerlyzer® product can also be used as an indicator of carbon monoxide poisoning in a healthcare environment. | Smokerlyzer | BEDFONT SCIENTIFIC LIMITED |
3 | 05060246860030 | ToxCO | TOXCO-USA | The ToxCO Breath Carbon Monoxide Monitor is used in the screening of Carbon Mono The ToxCO Breath Carbon Monoxide Monitor is used in the screening of Carbon Monoxide (CO) poisoning and calculation of the Carboxyhaemoglobin (COHb) level. The ToxCO Breath Carbon Monoxide Monitor can be used by healthcare professionals in medical institutions, emergency medical services where Carbon Monoxide exposure is suspected for paediatric, adult, and unconscious patients. | ToxCO | BEDFONT SCIENTIFIC LIMITED |
4 | 03760253450294 | V2 | TABATABA V2 | FIM MEDICAL | ||
5 | 03760253450287 | TRAPPER | TRAPPER | FIM MEDICAL | ||
6 | 03760253450263 | Pipette | Pipette | FIM MEDICAL | ||
7 | 00863571000318 | PFP-20300 | Pivot Breath Sensor | CARROT INC. WHICH WILL DO BUSINESS IN CALIFORNIA AS CARROT BEHAVIORAL HEALTH INC. | ||
8 | 00863571000301 | FP-20021 | Carbon Monoxide Breath Sensor | CARROT INC. WHICH WILL DO BUSINESS IN CALIFORNIA AS CARROT BEHAVIORAL HEALTH INC. | ||
9 | 00858481006017 | C20112 | A reusable electrical medical device with integrated software used in conjunctio 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. | CoSense ETCO Monitor | CAPNIA, INC. | |
10 | 54250892980145 | 36-SC01-STK | 36-SC01-STK | SmokeCheck | Micro Medical | CAREFUSION U.K. 232 LIMITED |
11 | 54250892980015 | 36-MC02-STK | 36-MC02-STK | MicroCO | Micro Medical | CAREFUSION U.K. 232 LIMITED |
12 | 54250892905506 | 36-MC02-STK | 36-MC02-STK | MicroCO | Vyaire | VYAIRE MEDICAL GMBH |
13 | 54250892901584 | 36-SC01-STK | 36-SC01-STK | SmokeCheck | Micro Medical | VYAIRE MEDICAL GMBH |
14 | 54250892901362 | 36-MC02-STK | 36-MC02-STK | MicroCO | Micro Medical | VYAIRE MEDICAL GMBH |
15 | 15099169297507 | 2900 | BREATHCO MONITOR | BreathCO | VITALOGRAPH (IRELAND) LIMITED | |
16 | 14250892904136 | 36-PSA2000 | 36-PSA2000 | MOUTHPIECE ADAPTOR | Vyaire | VYAIRE MEDICAL GMBH |
17 | 14250892904129 | 36-PSA1800 | 36-PSA1800 | Mouthpiece Adaptor | Vyaire | VYAIRE MEDICAL GMBH |
18 | 14250892901869 | 36-PSA1800 | 36-PSA1800 | MOUTHPIECE ADAPTOR | Micro Medical | VYAIRE MEDICAL GMBH |
19 | 14250892901838 | 36-PSA2000 | 36-PSA2000 | MOUTHPIECE ADAPTOR | Micro Medical | VYAIRE MEDICAL GMBH |
20 | 06944904098784 | CO2 module,M02C | 115-046935-00 | SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD. | ||
21 | 06944904098463 | 115-050568-00 | Sidestream CO2 module(FDA)II | SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD. | ||
22 | 06944904098456 | 115-050572-00 | IBP_CO_SidestreamCO2 module(FDA/FJ)II | SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD. | ||
23 | 06944904098449 | 115-050569-00 | IBP_CO_SidestreamCO2 module(FDA)II | SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD. | ||
24 | 06944904098432 | 115-050571-00 | Sidestream CO2 module(FDA/FJ)II | SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD. | ||
25 | 06944904096810 | 115-046939-00 | single CO2 Module(Neonate accessory kit) | SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD. | ||
26 | 06944904096803 | 115-046966-00 | ORIDION CO2 mod upgrd kit,intl | SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD. | ||
27 | 06944904096759 | 115-046928-00 | ORIDION CO2(Package/no accessory) | SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD. | ||
28 | 06944904096698 | 115-046938-00 | single CO2 Module(accessory kit) | SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD. | ||
29 | 06936415902759 | 115-053712-00 | 1-Slot CO2/O2 Module w/ kit (Neo) | SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD. | ||
30 | 06936415902674 | 115-053711-00 | 1-Slot CO2 Module w/ kit (Neo) | SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD. |