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Product Classification / EMDN Category

FDA Product Code: MXA

Directory of devices assigned to product classification code MXA.

classification System, Test, Breath Nitric Oxide Manufacturer:
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gudid Spare part: Vivatmo pro base station US Manufacturer: Bosch Healthcare Solutions GmbH
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gudid Spare part: Vivatmo pro handheld US Manufacturer: Bosch Healthcare Solutions GmbH
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gudid Vivatmo pro Nitric Oxide test is a portable, non-invasive device to measure fractional exhaled nitric oxide (FeNO) in human breath. Manufacturer: Bosch Healthcare Solutions GmbH
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gudid Disposable mouthpiece for Vivatmo Manufacturer: Bosch Healthcare Solutions GmbH
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gudid Disposable mouthpiece for Vivatmo Manufacturer: Bosch Healthcare Solutions GmbH
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gudid SW Fenom Flo V3.0.2 DownloadPOC App Manufacturer: MEDICAL GRAPHICS CORPORATION
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gudid Fenom Flo FeNO Monitoring System Manufacturer: MEDICAL GRAPHICS CORPORATION
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gudid Contains one sensor preprogrammed for a defined number of tests that is placed in the NIOX VERO device to enable a set amount of tests to be performed (1000). Also contains sufficient disposable patient filters (non-sterile) to be able to perform testing for each patient. Manufacturer: Circassia AB
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gudid Contains one sensor preprogrammed for a defined number of tests that is placed in the NIOX VERO device to enable a set amount of tests to be performed (500). Also contains sufficient disposable patient filters (non-sterile) to be able to perform testing for each patient. Manufacturer: Circassia AB
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gudid Contains one sensor preprogrammed for a defined number of tests that is placed in the NIOX VERO device to enable a set amount of tests to be performed (300). Also contains sufficient disposable patient filters (non-sterile) to be able to perform testing for each patient. Manufacturer: Circassia AB
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gudid Contains one sensor preprogrammed for a defined number of tests that is placed in the NIOX VERO device to enable a set amount of tests to be performed (100). Also contains sufficient disposable patient filters (non-sterile) to be able to perform testing for each patient. Manufacturer: Circassia AB
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gudid Contains One NIOX VERO device, one sensor pre-programmed for a defined number of tests that is placed in the NIOX VERO device to enable a set amount of tests to be performed (300) and sufficient disposable patient filters (non-sterile) to be able to perform testing for each patient. Manufacturer: Circassia AB
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gudid Contains One NIOX VERO device, one sensor pre-programmed for a defined number of tests that is placed in the NIOX VERO device to enable a set amount of tests to be performed (100) and sufficient disposable patient filters (non-sterile) to be able to perform testing for each patient. Manufacturer: Circassia AB
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gudid NIOX Apps / Panel is an optional software accessory allowing an additional display for the NIOX serise of Airway Inflammation Monitors including the NIOX MINO 09 and NIOX VERO devices. Manufacturer: Circassia AB
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gudid Disposable patient filter for use with the NIOX VERO device to be changed for each new measurement session and for each new patient. Manufacturer: Circassia AB
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gudid NIOX VERO measures Nitric Oxide (NO) in human breath. Nitric Oxide is frequently increased in some inflammatory processes such as asthma. The fractional NO concentration in expired breath (FeNO), can be measured by NIOX VERO according to guidelines for NO measurement established by the American Thoracic Society. Manufacturer: Circassia AB
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gudid Disposable filter (NIOX Filter) to be changed for each new measurement session and for each new patient and an accessory to the NIOX MINO 09 Manufacturer: Circassia AB
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gudid NIOX MINO measures Nitric Oxide (NO) in human breath. Nitric Oxide is frequently increased in some inflammatory processes such as asthma. The fractionalNO concentration in expired breath (FeNO), can be measured by NIOX MINO according to guidelines for NO measurement established by the AmericanThoracic Society. Manufacturer: Circassia AB
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gudid The NO sensor for NIOX VERO utilizes analytical electrochemical sensor technology. The NO sensor is pre-programmable for a defined number of tests: 60100300500 or 1000 tests. Manufacturer: Circassia AB
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gudid This is a rechargeable Li-Ion replacement battery for the NIOX VERO that is charged via the power supply or USB port. Manufacturer: Circassia AB
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gudid The NO sensor for NIOX VERO utilizes analytical electrochemical sensor technology. The NO sensor is pre-programmable for a defined number of tests: 60100300500 or 1000 tests. Manufacturer: Circassia AB
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gudid The NO sensor for NIOX VERO utilizes analytical electrochemical sensor technology. The NO sensor is pre-programmable for a defined number of tests: 60100300500 or 1000 tests. Manufacturer: Circassia AB
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gudid The NO sensor for NIOX VERO utilizes analytical electrochemical sensor technology. The NO sensor is pre-programmable for a defined number of tests: 60100300500 or 1000 tests. Manufacturer: Circassia AB
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gudid The NO sensor for NIOX VERO utilizes analytical electrochemical sensor technology. The NO sensor is pre-programmable for a defined number of tests: 60100300500 or 1000 tests. Manufacturer: Circassia AB
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gudid The NIOX VERO is supplied with an exchangeable handle accessory, to which the patient filter is attached and contains the NO scrubber filter. The handleshould be exchanged by the user every 1000 measurement or after one year of use. Manufacturer: Circassia AB
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gudid The NO sensor for NIOX MINO utilizes analytical electrochemical sensor technology. The NO sensor is pre-programmable for a defined number of tests: 50100300500 or 1000 tests. Manufacturer: Circassia AB
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gudid The NO Scrubber for the NIOX MINO device eliminates ambient NO that is inhaled by the patient, and creates an NO-free sample used for baseline control between every measurement. Manufacturer: Circassia AB
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gudid The NO sensor for NIOX MINO utilizes analytical electrochemical sensor technology. The NO sensor is pre-programmable for a defined number of tests: 50100300500 or 1000 tests. Manufacturer: Circassia AB
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gudid The NO sensor for NIOX MINO utilizes analytical electrochemical sensor technology. The NO sensor is pre-programmable for a defined number of tests: 50100300500 or 1000 tests. Manufacturer: Circassia AB
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gudid The NO sensor for NIOX MINO utilizes analytical electrochemical sensor technology. The NO sensor is pre-programmable for a defined number of tests: 50100300500 or 1000 tests. Manufacturer: Circassia AB
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gudid The NO sensor for NIOX MINO utilizes analytical electrochemical sensor technology. The NO sensor is pre-programmable for a defined number of tests: 50100300500 or 1000 tests. Manufacturer: Circassia AB
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gudid Box of 50 Fenom Pro Mouthpieces, PN 810-0006Sold in box of 50 only, individual mouthpieces are not for retail or commercial saleEach mouthpiece is individually packaged Manufacturer: Caire Diagnostics Inc.
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gudid Package contains:Fenom Pro Device - P/N 900-0001, GTIN 00860008017901 Configured for Australia/New ZealandAC Power Cord Cable, Australia/New Zealand - PN 415-0010 Manufacturer: Caire Diagnostics Inc.
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gudid Package contains:Fenom Pro Device - P/N 900-0001, GTIN 00860008017901 Configured as a Demo UnitInstructions for Use, Fenom Pro, US Configuration - P/N IFU-3393, as requiredInstructions for Use, Fenom Pro, PN IFU-3264, as requiredAC Power Cord Cable, US - PN 415-0003, as requiredAC Power Cord Cable, UK - PN 415-0004, as requiredAC Power Cord Cable, Switzerland, PN415-0008, as requiredAC Power Cord Cable, Europlug, PN 415-0011, as required Manufacturer: Caire Diagnostics Inc.
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gudid Package contains:Fenom Pro Device - P/N 900-0001, GTIN 00860008017901 Configured for EUInstructions for Use, Fenom Pro, - P/N IFU-3264AC Power Cord Cable, Europlug - PN 415-0011 Manufacturer: Caire Diagnostics Inc.
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gudid Package contains:Fenom Pro Device - P/N 900-0001, GTIN 00860008017901 Configured for USInstructions for Use, Fenom Pro, US Configuration - P/N IFU-3393AC Power Cord Cable, US - PN 415-0003 Manufacturer: Caire Diagnostics Inc.
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gudid Package contains:External Power Supply, P/N 197-0001Instructions for Use Reference, Fenom Pro - P/N FRM-3301 Manufacturer: Caire Diagnostics Inc.
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gudid 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. Manufacturer: BEDFONT SCIENTIFIC LIMITED
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gudid Designed specifically for the NObreath FeNO monitor, the NObreath mouthpiece (FeNObreath Mouthpiece) contains an integrated infection control filter that removes and traps >99% of airborne bacteria and >98% of viruses.The NObreath mouthpiece (FeNObreath Mouthpiece) may be used multiple times by one patient, per clinical visit.NOTE: The NObreath mouthpiece (FeNObreath Mouthpiece) is a single-patient use; re-use of the mouthpiece between patients can increase the risk of cross-inflection and result in incorrect readings. Manufacturer: BEDFONT SCIENTIFIC LIMITED
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gudid 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. Manufacturer: BEDFONT SCIENTIFIC LIMITED
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