Device Description : Consumables to be used with the MediByte. The single-use kit contains: 3.6 V 1/2 Consumables to be used with the MediByte. The single-use kit contains: 3.6 V 1/2 AA Lithium Battery, 8597 Oronasal cannula, Snap Electrodes and Snap Electrode Prep Pads.
Device Class :
Duns Number: 251731105
Premarket Exempt : Yes
Prescription Use : Yes
Device Description : Consumables to be used with the MediByte. The single-use kit contains: Nonin Fle Consumables to be used with the MediByte. The single-use kit contains: Nonin Flexiwrap Probe Tape, 3.6 V 1/2 AA Lithium Battery, 8597 Oronasal cannula, Snap Electrodes and Snap Electrode Prep Pads.
Device Class :
Duns Number: 251731105
Premarket Exempt : Yes
Prescription Use : Yes
Device Description : Cable for attaching the MediByte Disposable Airflow Sensor.
Device Class : 2
Duns Number: 251731105
Premarket Exempt : No
Prescription Use : Yes
Device Description : Cannula thermistor intended for use during sleep disorders studies as a qualitat Cannula thermistor intended for use during sleep disorders studies as a qualitative measure of respiratory airflow for use with MediByte.
Device Class : 2
Duns Number: 251731105
Premarket Exempt : No
Prescription Use : Yes
Device Description : For use during sleep disorder studies as a measure of snoring for recording with For use during sleep disorder studies as a measure of snoring for recording with a MediByte.
Device Class : 2
Duns Number: 251731105
Premarket Exempt : No
Prescription Use : Yes
Device Description : Belt intended for use during sleep disorder studies as a measure of respiratory Belt intended for use during sleep disorder studies as a measure of respiratory effort for recording with a MediByte.
Device Class : 2
Duns Number: 251731105
Premarket Exempt : No
Prescription Use : Yes
Device Description : Belt intended for use during sleep disorder studies as a measure of respiratory Belt intended for use during sleep disorder studies as a measure of respiratory effort for recording with a MediByte.
Device Class : 2
Duns Number: 251731105
Premarket Exempt : No
Prescription Use : Yes
Device Description : Belt intended for use during sleep disorder studies as a measure of respiratory Belt intended for use during sleep disorder studies as a measure of respiratory effort for recording with a MediByte.
Device Class : 2
Duns Number: 251731105
Premarket Exempt : No
Prescription Use : Yes
Device Description : Cable for Disposable RIP Belt which is intended for use during sleep disorder s Cable for Disposable RIP Belt which is intended for use during sleep disorder studies as a measure of respiratory effort for recording with a MediByte. The sensor uses respiratory inductance plethysmography (RIP) technology and plugs directly into an electrode head box or a DC amplifier.
Device Class : 2
Duns Number: 251731105
Premarket Exempt : No
Prescription Use : Yes
Device Description : Cable for Disposable RIP Belt which is intended for use during sleep disorder s Cable for Disposable RIP Belt which is intended for use during sleep disorder studies as a measure of respiratory effort for recording with a MediByte. The sensor uses respiratory inductance plethysmography (RIP) technology and plugs directly into an electrode head box or a DC amplifier.
Device Class : 2
Duns Number: 251731105
Premarket Exempt : No
Prescription Use : Yes