RESPIRATORY MOTION INC.

Address:80 Coolidge Hill Rd,Watertown,MA,02472,US

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Device Class

Class-1 (A medical device with low to moderate risk that requires general controls) Class-2 (A medical device with a moderate to high risk that requires special controls) Class-3 (A medical device with high risk that requires premarket approval) Class-U (Unclassified)

Product Code

Monitor, Breathing Frequency (BZQ) (6) Spirometer, Monitoring (W/Wo Alarm) (BZK) (6)

Premarket Exempt

No Yes

Clear

ExSpiron 1Xi - 00851540007000 Catalog Number : RMI-51000

Device Description : A noninvasive device designed to continuously measure a patient's tidal volume, A noninvasive device designed to continuously measure a patient's tidal volume, minute ventilation, and respiratory rate via impedance pneumography. Designed to be connected to the ExSpiron 1Xi PadSet via the ExSpiron 1Xi Patient Cable, the ExSpiron 1Xi Monitor provides a measurement of a patient's respiratory parameters, while also incorporating alarms. The ExSpiron 1Xi Monitor can be integrated into a medical facility's nurse call system via the ExSpiron 1Xi Nurse Call Module.

Device Class :

Duns Number: 963613745

Premarket Exempt : No

Product Code : BZK, BZQ

Prescription Use : Yes

Device Count : 1

ExSpiron 1Xi - 00851540007017 Catalog Number : RMI-51130

Device Description : Noninvasive, insulated, electrical cable designed to connect the ExSpiron 1Xi Mo Noninvasive, insulated, electrical cable designed to connect the ExSpiron 1Xi Monitor to the ExSpiron 1Xi PadSet.

Device Class :

Duns Number: 963613745

Premarket Exempt : No

Product Code : BZQ, BZK

Prescription Use : Yes

Device Count : 1

ExSpiron 1Xi - 00851540007024 Catalog Number : RMI-51250

Device Description : Insulated, reusable, medical grade electrical cord design to enable connection o Insulated, reusable, medical grade electrical cord design to enable connection of the ExSpiron 1Xi to a mains electricity supply socket, with a NEMA 5-15P plug and an IEC 60320-C13 connector at either end.

Device Class :

Duns Number: 963613745

Premarket Exempt : No

Product Code : BZQ, BZK

Prescription Use : No

Device Count : 1

ExSpiron 1Xi - 00851540007048 Catalog Number : RMI-51110

Device Description : A non-sterile, single use electrode set designed to be adhered across a patient' A non-sterile, single use electrode set designed to be adhered across a patient's chest and connected to the ExSpiron 1Xi Monitor for impedance pneumography. Consists of electrodes and lead wire to allow for impedance measurements across a chest cavity.

Device Class :

Duns Number: 963613745

Premarket Exempt : No

Product Code : BZQ, BZK

Prescription Use : Yes

Device Count : 1

ExSpiron 1Xi - 00851540007055 Catalog Number : RMI-51155

Device Description : Assembly designed to be integrated into medical facility infrastructure in order Assembly designed to be integrated into medical facility infrastructure in order to trigger a nurse call alarm system. Designed to be used only with the ExSpiron 1Xi Monitor.

Device Class :

Duns Number: 963613745

Premarket Exempt : Yes

Product Code : BZQ, BZK

Prescription Use : Yes

Device Count : 1

ExSpiron 2Xi - 00851540007147 Catalog Number :

Device Description : A noninvasive device designed to continuously measure a patient's tidal volume, A noninvasive device designed to continuously measure a patient's tidal volume, minute ventilation, and respiratory rate via impedance pneumography. Designed to be connected to the ExSpiron PadSet via the ExSpiron Patient Cable, the ExSpiron 2Xi Monitor provides a measurement of a patient's respiratory parameters, while also incorporating alarms. The ExSpiron 2Xi Monitor can be integrated into a medical facility's nurse call system.

Device Class :

Duns Number: 963613745

Premarket Exempt : No

Product Code : BZQ, BZK

Prescription Use : Yes

Device Count : 1

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