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Company Name Brand Name GMDN Term Name GMDN Term Status FDA Product Code Name FDA Product Code Device Packaged As Sterile Sterilization Prior To Use Issuing Agency Device Size Device Size Type Device Class Implantable

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MicroCO
Jaeger Medical GmbH
36-MC02-STK
In Commercial Distribution

  • 54250892905506 ()
36-MC02-STK

  • Carbon monoxide breath analyser
SmokeCheck
Jaeger Medical GmbH
36-SC01-STK
Not in Commercial Distribution

  • 54250892901584 ()
36-SC01-STK

  • Carbon monoxide breath analyser
MicroCO
Jaeger Medical GmbH
36-MC02-STK
Not in Commercial Distribution

  • 54250892901362 ()
36-MC02-STK

  • Carbon monoxide breath analyser
SmokeCheck
CAREFUSION U.K. 232 LIMITED
36-SC01-STK
Not in Commercial Distribution

  • 54250892980145 ()
36-SC01-STK

  • Carbon monoxide breath analyser
No Description
FIM MEDICAL
V2
In Commercial Distribution

  • 03760253450294 ()


  • Carbon monoxide breath analyser
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.
BEDFONT SCIENTIFIC LIMITED
iCO Quit
In Commercial Distribution

  • 05060246860429 ()
ICOQUIT

  • Carbon monoxide breath analyser
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.
BEDFONT SCIENTIFIC LIMITED
Micro+
In Commercial Distribution

  • 05060246860047 ()
MICROADV

  • Carbon monoxide breath analyser
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.
BEDFONT SCIENTIFIC LIMITED
ToxCO
In Commercial Distribution

  • 05060246860030 ()
TOXCO-USA

  • Carbon monoxide breath analyser
Used for calibrating analyzers that measure the amount of carbon monoxide diffused through the lungs.
Roberts Oxygen Company, Inc.
1
In Commercial Distribution

  • 00860009502000 ()


  • Carbon monoxide breath analyser
GAS, CALIBRATION (SPECIFIED CONCENTRATION) - Lung Diffusion Mixture
Matheson Tri-Gas, Inc.
1
In Commercial Distribution

  • 00860009629509 ()


  • Carbon monoxide breath analyser
GAS, CALIBRATION (SPECIFIED CONCENTRATION) - Lung Diffusion Mixture
A-Ox Welding Supply, Co., Inc.
1
In Commercial Distribution

  • 00860009617407 ()


  • Carbon monoxide breath analyser
GAS, CALIBRATION (SPECIFIED CONCENTRATION) - Lung Diffusion Gas Mixture
General Air Service & Supply Co
1
In Commercial Distribution

  • 00860009597815 ()


  • Carbon monoxide breath analyser
GAS, CALIBRATION (SPECIFIED CONCENTRATION) - Lung Diffusion Mixture
Industrial Source
1
In Commercial Distribution

  • 00860009591820 ()


  • Carbon monoxide breath analyser
GAS, CALIBRATION (SPECIFIED CONCENTRATION) - GAS, CALIBRATION (SPECIFIED CONCENTRATION) -
Middlesex Gases & Technologies, Inc.
1
In Commercial Distribution

  • 00860009591721 ()


  • Carbon monoxide breath analyser
GAS, CALIBRATION (SPECIFIED CONCENTRATION) - Lung Diffusion Mixtures
Ilmo Products Company
1
In Commercial Distribution

  • 00860009591530 ()


  • Carbon monoxide breath analyser
GAS, CALIBRATION (SPECIFIED CONCENTRATION) - Lung Diffusion Mixture
Oxarc, Inc.
1
In Commercial Distribution

  • 00860009626232 ()


  • Carbon monoxide breath analyser
GAS, CALIBRATION (SPECIFIED CONCENTRATION) - Lung Diffusion Test Mixture
Red Ball Oxygen Co., Inc.
1
In Commercial Distribution

  • 00860009625914 ()


  • Carbon monoxide breath analyser
Used for calibrating analyzers that measure the amount of carbon monoxide diffused through the lungs.
Norco, Inc.
Medical Calibration Gas
In Commercial Distribution

  • 00860009621909 ()


  • Carbon monoxide breath analyser
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.
CAPNIA, INC.
C20112
In Commercial Distribution

  • 00858481006017 ()


  • Carbon monoxide breath analyser
No Description
CARROT INC. WHICH WILL DO BUSINESS IN CALIFORNIA AS CARROT BEHAVIORAL HEALTH INC.
PFP-20300
In Commercial Distribution

  • 00863571000318 ()


  • Carbon monoxide breath analyser
No Description
CARROT INC. WHICH WILL DO BUSINESS IN CALIFORNIA AS CARROT BEHAVIORAL HEALTH INC.
FP-20021
Not in Commercial Distribution

  • 00863571000301 ()


  • Carbon monoxide breath analyser
Lung Diffusion Mixture (of Specified Concentration) GAS, CALIBRATION (SPECIFIED CONCENTRATION) - Lung Diffusion Mixture
Linde Gas & Equipment Inc.
1
In Commercial Distribution

  • 00850046301162 ()


  • Carbon monoxide breath analyser
Description: 2% ENFLURANE, BAL. N2; Cylinder: XL; Valve: CGA 510; For calibration of medical analyzers in accordance with manufacturer's instructions.
AIRGAS USA LLC
Calibration Gas
In Commercial Distribution

  • 00819601020429 ()

  • Total Volume: 54 Liter
  • Pressure: 398 Pound per Square Inch
Z02NI98M350Y050

  • Carbon monoxide breath analyser
Description: 0.3% CO, 10% He, 21% O2, Bal. N2; Cylinder: EL; Valve: CGA 973; For use with Pulmonary Function Diagnostic Equipment in accordance with manufacturer's instructions.
AIRGAS USA LLC
Pulmonary Function Gas
In Commercial Distribution

  • 00819601020412 ()

  • Total Volume: 620 Liter
  • Pressure: 2000 Pound per Square Inch
Z04NI685EA0033

  • Carbon monoxide breath analyser
Description: 0.3% CO18, 0.6% C2H2, 9% He, 45% O2, Bal. N2; Cylinder: H; Valve: CGA 296; For use with Pulmonary Function Diagnostic Equipment in accordance with manufacturer's instructions.
AIRGAS USA LLC
Pulmonary Function Gas
In Commercial Distribution

  • 00819601020405 ()

  • Total Volume: 1115 Liter
  • Pressure: 370 Pound per Square Inch
Z05NI458200C000

  • Carbon monoxide breath analyser
Description: 0.3% CO18, 10% He, 35% O2, Bal. N2; Cylinder: AG 80; Valve: CGA 296; For use with Pulmonary Function Diagnostic Equipment in accordance with manufacturer's instructions.
AIRGAS USA LLC
Pulmonary Function Gas
In Commercial Distribution

  • 00819601020399 ()

  • Total Volume: 1578 Liter
  • Pressure: 1450 Pound per Square Inch
Z04NI54M80C000

  • Carbon monoxide breath analyser
Used for calibrating analyzers that measure the amount of carbon monoxide diffused through the lungs.
AIRGAS USA LLC
Device Gas
In Commercial Distribution

  • 00819601020047 ()
Lung Diffusion Gas

  • Carbon monoxide breath analyser
BREATHCO MONITOR
VITALOGRAPH (IRELAND) LIMITED
2900
In Commercial Distribution

  • 05099169297500 ()
  • 15099169297507 ()


  • Carbon monoxide breath analyser
MOUTHPIECE ADAPTOR
Jaeger Medical GmbH
36-PSA1800
Not in Commercial Distribution

  • 14250892901869 ()
36-PSA1800

  • Carbon monoxide breath analyser
MOUTHPIECE ADAPTOR
Jaeger Medical GmbH
36-PSA2000
Not in Commercial Distribution

  • 14250892901838 ()
36-PSA2000

  • Carbon monoxide breath analyser
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