ExSpiron 2Xi

GUDID 00851540007147

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.

RESPIRATORY MOTION INC.

Monitoring spirometer, electrical
Primary Device ID00851540007147
NIH Device Record Keyec43e40b-7201-43eb-aada-df2ba4e71109
Commercial Distribution StatusIn Commercial Distribution
Brand NameExSpiron 2Xi
Version Model NumberRMI-54000
Company DUNS963613745
Company NameRESPIRATORY MOTION INC.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusMR Unsafe
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numbertrue
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone7816097829
Emailsupport@respiratorymotion.com
Phone2399204288
Emailinfo.us@senzime.com
Phone2399204288
Emailinfo.us@senzime.com
Phone2399204288
Emailinfo.us@senzime.com
Phone2399204288
Emailinfo.us@senzime.com
Phone2399204288
Emailinfo.us@senzime.com
Phone2399204288
Emailinfo.us@senzime.com
Phone2399204288
Emailinfo.us@senzime.com
Phone2399204288
Emailinfo.us@senzime.com
Phone2399204288
Emailinfo.us@senzime.com
Phone2399204288
Emailinfo.us@senzime.com
Phone2399204288
Emailinfo.us@senzime.com
Phone2399204288
Emailinfo.us@senzime.com
Phone2399204288
Emailinfo.us@senzime.com
Phone2399204288
Emailinfo.us@senzime.com
Phone2399204288
Emailinfo.us@senzime.com
Phone2399204288
Emailinfo.us@senzime.com
Phone2399204288
Emailinfo.us@senzime.com
Phone2399204288
Emailinfo.us@senzime.com
Phone800-213-1324
Emailinfo.us@senzime.com
Phone800-213-1324
Emailinfo.us@senzime.com
Phone800-213-1324
Emailinfo.us@senzime.com
Phone800-213-1324
Emailinfo.us@senzime.com
Phone800-213-1324
Emailinfo.us@senzime.com
Phone800-213-1324
Emailinfo.us@senzime.com
Phone800-213-1324
Emailinfo.us@senzime.com
Phone800-213-1324
Emailinfo.us@senzime.com
Phone800-213-1324
Emailinfo.us@senzime.com
Phone800-213-1324
Emailinfo.us@senzime.com
Phone800-213-1324
Emailinfo.us@senzime.com
Phone800-213-1324
Emailinfo.us@senzime.com
Phone800-213-1324
Emailinfo.us@senzime.com
Phone800-213-1324
Emailinfo.us@senzime.com
Phone800-213-1324
Emailinfo.us@senzime.com
Phone800-213-1324
Emailinfo.us@senzime.com
Phone800-213-1324
Emailinfo.us@senzime.com
Phone800-213-1324
Emailinfo.us@senzime.com
Phone800-213-1324
Emailinfo.us@senzime.com
Phone800-213-1324
Emailinfo.us@senzime.com
Phone800-213-1324
Emailinfo.us@senzime.com
Phone800-213-1324
Emailinfo.us@senzime.com
Phone800-213-1324
Emailinfo.us@senzime.com
Phone800-213-1324
Emailinfo.us@senzime.com
Phone800-213-1324
Emailinfo.us@senzime.com
Phone800-213-1324
Emailinfo.us@senzime.com
Phone800-213-1324
Emailinfo.us@senzime.com
Phone800-213-1324
Emailinfo.us@senzime.com
Phone800-213-1324
Emailinfo.us@senzime.com
Phone800-213-1324
Emailinfo.us@senzime.com
Phone800-213-1324
Emailinfo.us@senzime.com
Phone800-213-1324
Emailinfo.us@senzime.com
Phone800-213-1324
Emailinfo.us@senzime.com
Phone800-213-1324
Emailinfo.us@senzime.com
Phone800-213-1324
Emailinfo.us@senzime.com
Phone800-213-1324
Emailinfo.us@senzime.com
Phone800-213-1324
Emailinfo.us@senzime.com
Phone800-213-1324
Emailinfo.us@senzime.com
Phone800-213-1324
Emailinfo.us@senzime.com
Phone800-213-1324
Emailinfo.us@senzime.com
Phone800-213-1324
Emailinfo.us@senzime.com
Phone800-213-1324
Emailinfo.us@senzime.com
Phone800-213-1324
Emailinfo.us@senzime.com
Phone800-213-1324
Emailinfo.us@senzime.com
Phone800-213-1324
Emailinfo.us@senzime.com
Phone800-213-1324
Emailinfo.us@senzime.com
Phone800-213-1324
Emailinfo.us@senzime.com
Phone800-213-1324
Emailinfo.us@senzime.com
Phone800-213-1324
Emailinfo.us@senzime.com
Phone800-213-1324
Emailinfo.us@senzime.com
Phone800-213-1324
Emailinfo.us@senzime.com

Operating and Storage Conditions

Storage Environment TemperatureBetween -20 Degrees Celsius and 65 Degrees Celsius
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 80 KiloPascal and 101 KiloPascal
Handling Environment TemperatureBetween 5 Degrees Celsius and 32 Degrees Celsius
Handling Environment HumidityBetween 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 80 KiloPascal and 101 KiloPascal
Storage Environment TemperatureBetween -20 Degrees Celsius and 65 Degrees Celsius
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 80 KiloPascal and 101 KiloPascal
Handling Environment TemperatureBetween 5 Degrees Celsius and 32 Degrees Celsius
Handling Environment HumidityBetween 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 80 KiloPascal and 101 KiloPascal
Storage Environment TemperatureBetween -20 Degrees Celsius and 65 Degrees Celsius
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 80 KiloPascal and 101 KiloPascal
Handling Environment TemperatureBetween 5 Degrees Celsius and 32 Degrees Celsius
Handling Environment HumidityBetween 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 80 KiloPascal and 101 KiloPascal
Storage Environment TemperatureBetween -20 Degrees Celsius and 65 Degrees Celsius
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 80 KiloPascal and 101 KiloPascal
Handling Environment TemperatureBetween 5 Degrees Celsius and 32 Degrees Celsius
Handling Environment HumidityBetween 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 80 KiloPascal and 101 KiloPascal
Storage Environment TemperatureBetween -20 Degrees Celsius and 65 Degrees Celsius
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 80 KiloPascal and 101 KiloPascal
Handling Environment TemperatureBetween 5 Degrees Celsius and 32 Degrees Celsius
Handling Environment HumidityBetween 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 80 KiloPascal and 101 KiloPascal
Storage Environment TemperatureBetween -20 Degrees Celsius and 65 Degrees Celsius
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 80 KiloPascal and 101 KiloPascal
Handling Environment TemperatureBetween 5 Degrees Celsius and 32 Degrees Celsius
Handling Environment HumidityBetween 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 80 KiloPascal and 101 KiloPascal
Storage Environment TemperatureBetween -20 Degrees Celsius and 65 Degrees Celsius
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 80 KiloPascal and 101 KiloPascal
Handling Environment TemperatureBetween 5 Degrees Celsius and 32 Degrees Celsius
Handling Environment HumidityBetween 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 80 KiloPascal and 101 KiloPascal
Storage Environment TemperatureBetween -20 Degrees Celsius and 65 Degrees Celsius
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 80 KiloPascal and 101 KiloPascal
Handling Environment TemperatureBetween 5 Degrees Celsius and 32 Degrees Celsius
Handling Environment HumidityBetween 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 80 KiloPascal and 101 KiloPascal
Storage Environment TemperatureBetween -20 Degrees Celsius and 65 Degrees Celsius
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 80 KiloPascal and 101 KiloPascal
Handling Environment TemperatureBetween 5 Degrees Celsius and 32 Degrees Celsius
Handling Environment HumidityBetween 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 80 KiloPascal and 101 KiloPascal
Storage Environment TemperatureBetween -20 Degrees Celsius and 65 Degrees Celsius
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 80 KiloPascal and 101 KiloPascal
Handling Environment TemperatureBetween 5 Degrees Celsius and 32 Degrees Celsius
Handling Environment HumidityBetween 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 80 KiloPascal and 101 KiloPascal
Storage Environment TemperatureBetween -20 Degrees Celsius and 65 Degrees Celsius
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 80 KiloPascal and 101 KiloPascal
Handling Environment TemperatureBetween 5 Degrees Celsius and 32 Degrees Celsius
Handling Environment HumidityBetween 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 80 KiloPascal and 101 KiloPascal
Storage Environment TemperatureBetween -20 Degrees Celsius and 65 Degrees Celsius
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 80 KiloPascal and 101 KiloPascal
Handling Environment TemperatureBetween 5 Degrees Celsius and 32 Degrees Celsius
Handling Environment HumidityBetween 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 80 KiloPascal and 101 KiloPascal
Storage Environment TemperatureBetween -20 Degrees Celsius and 65 Degrees Celsius
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 80 KiloPascal and 101 KiloPascal
Handling Environment TemperatureBetween 5 Degrees Celsius and 32 Degrees Celsius
Handling Environment HumidityBetween 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 80 KiloPascal and 101 KiloPascal
Storage Environment TemperatureBetween -20 Degrees Celsius and 65 Degrees Celsius
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 80 KiloPascal and 101 KiloPascal
Handling Environment TemperatureBetween 5 Degrees Celsius and 32 Degrees Celsius
Handling Environment HumidityBetween 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 80 KiloPascal and 101 KiloPascal
Storage Environment TemperatureBetween -20 Degrees Celsius and 65 Degrees Celsius
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 80 KiloPascal and 101 KiloPascal
Handling Environment TemperatureBetween 5 Degrees Celsius and 32 Degrees Celsius
Handling Environment HumidityBetween 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 80 KiloPascal and 101 KiloPascal
Storage Environment TemperatureBetween -20 Degrees Celsius and 65 Degrees Celsius
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 80 KiloPascal and 101 KiloPascal
Handling Environment TemperatureBetween 5 Degrees Celsius and 32 Degrees Celsius
Handling Environment HumidityBetween 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 80 KiloPascal and 101 KiloPascal
Storage Environment TemperatureBetween -20 Degrees Celsius and 65 Degrees Celsius
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 80 KiloPascal and 101 KiloPascal
Handling Environment TemperatureBetween 5 Degrees Celsius and 32 Degrees Celsius
Handling Environment HumidityBetween 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 80 KiloPascal and 101 KiloPascal
Storage Environment TemperatureBetween -20 Degrees Celsius and 65 Degrees Celsius
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 80 KiloPascal and 101 KiloPascal
Handling Environment TemperatureBetween 5 Degrees Celsius and 32 Degrees Celsius
Handling Environment HumidityBetween 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 80 KiloPascal and 101 KiloPascal
Storage Environment TemperatureBetween -20 Degrees Celsius and 65 Degrees Celsius
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 80 KiloPascal and 101 KiloPascal
Handling Environment TemperatureBetween 5 Degrees Celsius and 32 Degrees Celsius
Handling Environment HumidityBetween 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 80 KiloPascal and 101 KiloPascal
Storage Environment TemperatureBetween -20 Degrees Celsius and 65 Degrees Celsius
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 80 KiloPascal and 101 KiloPascal
Handling Environment TemperatureBetween 5 Degrees Celsius and 32 Degrees Celsius
Handling Environment HumidityBetween 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 80 KiloPascal and 101 KiloPascal
Storage Environment TemperatureBetween -20 Degrees Celsius and 65 Degrees Celsius
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 80 KiloPascal and 101 KiloPascal
Handling Environment TemperatureBetween 5 Degrees Celsius and 32 Degrees Celsius
Handling Environment HumidityBetween 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 80 KiloPascal and 101 KiloPascal
Storage Environment TemperatureBetween -20 Degrees Celsius and 65 Degrees Celsius
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 80 KiloPascal and 101 KiloPascal
Handling Environment TemperatureBetween 5 Degrees Celsius and 32 Degrees Celsius
Handling Environment HumidityBetween 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 80 KiloPascal and 101 KiloPascal
Storage Environment TemperatureBetween -20 Degrees Celsius and 65 Degrees Celsius
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 80 KiloPascal and 101 KiloPascal
Handling Environment TemperatureBetween 5 Degrees Celsius and 32 Degrees Celsius
Handling Environment HumidityBetween 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 80 KiloPascal and 101 KiloPascal
Storage Environment TemperatureBetween -20 Degrees Celsius and 65 Degrees Celsius
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 80 KiloPascal and 101 KiloPascal
Handling Environment TemperatureBetween 5 Degrees Celsius and 32 Degrees Celsius
Handling Environment HumidityBetween 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 80 KiloPascal and 101 KiloPascal
Storage Environment TemperatureBetween -20 Degrees Celsius and 65 Degrees Celsius
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 80 KiloPascal and 101 KiloPascal
Handling Environment TemperatureBetween 5 Degrees Celsius and 32 Degrees Celsius
Handling Environment HumidityBetween 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 80 KiloPascal and 101 KiloPascal
Storage Environment TemperatureBetween -20 Degrees Celsius and 65 Degrees Celsius
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 80 KiloPascal and 101 KiloPascal
Handling Environment TemperatureBetween 5 Degrees Celsius and 32 Degrees Celsius
Handling Environment HumidityBetween 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 80 KiloPascal and 101 KiloPascal
Storage Environment TemperatureBetween -20 Degrees Celsius and 65 Degrees Celsius
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 80 KiloPascal and 101 KiloPascal
Handling Environment TemperatureBetween 5 Degrees Celsius and 32 Degrees Celsius
Handling Environment HumidityBetween 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 80 KiloPascal and 101 KiloPascal
Storage Environment TemperatureBetween -20 Degrees Celsius and 65 Degrees Celsius
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 80 KiloPascal and 101 KiloPascal
Handling Environment TemperatureBetween 5 Degrees Celsius and 32 Degrees Celsius
Handling Environment HumidityBetween 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 80 KiloPascal and 101 KiloPascal
Storage Environment TemperatureBetween -20 Degrees Celsius and 65 Degrees Celsius
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 80 KiloPascal and 101 KiloPascal
Handling Environment TemperatureBetween 5 Degrees Celsius and 32 Degrees Celsius
Handling Environment HumidityBetween 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 80 KiloPascal and 101 KiloPascal
Storage Environment TemperatureBetween -20 Degrees Celsius and 65 Degrees Celsius
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 80 KiloPascal and 101 KiloPascal
Handling Environment TemperatureBetween 5 Degrees Celsius and 32 Degrees Celsius
Handling Environment HumidityBetween 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 80 KiloPascal and 101 KiloPascal
Storage Environment TemperatureBetween -20 Degrees Celsius and 65 Degrees Celsius
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 80 KiloPascal and 101 KiloPascal
Handling Environment TemperatureBetween 5 Degrees Celsius and 32 Degrees Celsius
Handling Environment HumidityBetween 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 80 KiloPascal and 101 KiloPascal
Storage Environment TemperatureBetween -20 Degrees Celsius and 65 Degrees Celsius
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 80 KiloPascal and 101 KiloPascal
Handling Environment TemperatureBetween 5 Degrees Celsius and 32 Degrees Celsius
Handling Environment HumidityBetween 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 80 KiloPascal and 101 KiloPascal
Storage Environment TemperatureBetween -20 Degrees Celsius and 65 Degrees Celsius
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 80 KiloPascal and 101 KiloPascal
Handling Environment TemperatureBetween 5 Degrees Celsius and 32 Degrees Celsius
Handling Environment HumidityBetween 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 80 KiloPascal and 101 KiloPascal
Storage Environment TemperatureBetween -20 Degrees Celsius and 65 Degrees Celsius
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 80 KiloPascal and 101 KiloPascal
Handling Environment TemperatureBetween 5 Degrees Celsius and 32 Degrees Celsius
Handling Environment HumidityBetween 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 80 KiloPascal and 101 KiloPascal
Storage Environment TemperatureBetween -20 Degrees Celsius and 65 Degrees Celsius
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 80 KiloPascal and 101 KiloPascal
Handling Environment TemperatureBetween 5 Degrees Celsius and 32 Degrees Celsius
Handling Environment HumidityBetween 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 80 KiloPascal and 101 KiloPascal
Storage Environment TemperatureBetween -20 Degrees Celsius and 65 Degrees Celsius
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 80 KiloPascal and 101 KiloPascal
Handling Environment TemperatureBetween 5 Degrees Celsius and 32 Degrees Celsius
Handling Environment HumidityBetween 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 80 KiloPascal and 101 KiloPascal
Storage Environment TemperatureBetween -20 Degrees Celsius and 65 Degrees Celsius
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 80 KiloPascal and 101 KiloPascal
Handling Environment TemperatureBetween 5 Degrees Celsius and 32 Degrees Celsius
Handling Environment HumidityBetween 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 80 KiloPascal and 101 KiloPascal
Storage Environment TemperatureBetween -20 Degrees Celsius and 65 Degrees Celsius
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 80 KiloPascal and 101 KiloPascal
Handling Environment TemperatureBetween 5 Degrees Celsius and 32 Degrees Celsius
Handling Environment HumidityBetween 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 80 KiloPascal and 101 KiloPascal
Storage Environment TemperatureBetween -20 Degrees Celsius and 65 Degrees Celsius
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 80 KiloPascal and 101 KiloPascal
Handling Environment TemperatureBetween 5 Degrees Celsius and 32 Degrees Celsius
Handling Environment HumidityBetween 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 80 KiloPascal and 101 KiloPascal
Storage Environment TemperatureBetween -20 Degrees Celsius and 65 Degrees Celsius
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 80 KiloPascal and 101 KiloPascal
Handling Environment TemperatureBetween 5 Degrees Celsius and 32 Degrees Celsius
Handling Environment HumidityBetween 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 80 KiloPascal and 101 KiloPascal
Storage Environment TemperatureBetween -20 Degrees Celsius and 65 Degrees Celsius
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 80 KiloPascal and 101 KiloPascal
Handling Environment TemperatureBetween 5 Degrees Celsius and 32 Degrees Celsius
Handling Environment HumidityBetween 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 80 KiloPascal and 101 KiloPascal
Storage Environment TemperatureBetween -20 Degrees Celsius and 65 Degrees Celsius
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 80 KiloPascal and 101 KiloPascal
Handling Environment TemperatureBetween 5 Degrees Celsius and 32 Degrees Celsius
Handling Environment HumidityBetween 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 80 KiloPascal and 101 KiloPascal
Storage Environment TemperatureBetween -20 Degrees Celsius and 65 Degrees Celsius
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 80 KiloPascal and 101 KiloPascal
Handling Environment TemperatureBetween 5 Degrees Celsius and 32 Degrees Celsius
Handling Environment HumidityBetween 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 80 KiloPascal and 101 KiloPascal
Storage Environment TemperatureBetween -20 Degrees Celsius and 65 Degrees Celsius
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 80 KiloPascal and 101 KiloPascal
Handling Environment TemperatureBetween 5 Degrees Celsius and 32 Degrees Celsius
Handling Environment HumidityBetween 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 80 KiloPascal and 101 KiloPascal
Storage Environment TemperatureBetween -20 Degrees Celsius and 65 Degrees Celsius
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 80 KiloPascal and 101 KiloPascal
Handling Environment TemperatureBetween 5 Degrees Celsius and 32 Degrees Celsius
Handling Environment HumidityBetween 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 80 KiloPascal and 101 KiloPascal
Storage Environment TemperatureBetween -20 Degrees Celsius and 65 Degrees Celsius
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 80 KiloPascal and 101 KiloPascal
Handling Environment TemperatureBetween 5 Degrees Celsius and 32 Degrees Celsius
Handling Environment HumidityBetween 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 80 KiloPascal and 101 KiloPascal
Storage Environment TemperatureBetween -20 Degrees Celsius and 65 Degrees Celsius
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 80 KiloPascal and 101 KiloPascal
Handling Environment TemperatureBetween 5 Degrees Celsius and 32 Degrees Celsius
Handling Environment HumidityBetween 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 80 KiloPascal and 101 KiloPascal
Storage Environment TemperatureBetween -20 Degrees Celsius and 65 Degrees Celsius
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 80 KiloPascal and 101 KiloPascal
Handling Environment TemperatureBetween 5 Degrees Celsius and 32 Degrees Celsius
Handling Environment HumidityBetween 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 80 KiloPascal and 101 KiloPascal
Storage Environment TemperatureBetween -20 Degrees Celsius and 65 Degrees Celsius
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 80 KiloPascal and 101 KiloPascal
Handling Environment TemperatureBetween 5 Degrees Celsius and 32 Degrees Celsius
Handling Environment HumidityBetween 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 80 KiloPascal and 101 KiloPascal
Storage Environment TemperatureBetween -20 Degrees Celsius and 65 Degrees Celsius
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 80 KiloPascal and 101 KiloPascal
Handling Environment TemperatureBetween 5 Degrees Celsius and 32 Degrees Celsius
Handling Environment HumidityBetween 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 80 KiloPascal and 101 KiloPascal
Storage Environment TemperatureBetween -20 Degrees Celsius and 65 Degrees Celsius
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 80 KiloPascal and 101 KiloPascal
Handling Environment TemperatureBetween 5 Degrees Celsius and 32 Degrees Celsius
Handling Environment HumidityBetween 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 80 KiloPascal and 101 KiloPascal
Storage Environment TemperatureBetween -20 Degrees Celsius and 65 Degrees Celsius
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 80 KiloPascal and 101 KiloPascal
Handling Environment TemperatureBetween 5 Degrees Celsius and 32 Degrees Celsius
Handling Environment HumidityBetween 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 80 KiloPascal and 101 KiloPascal
Storage Environment TemperatureBetween -20 Degrees Celsius and 65 Degrees Celsius
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 80 KiloPascal and 101 KiloPascal
Handling Environment TemperatureBetween 5 Degrees Celsius and 32 Degrees Celsius
Handling Environment HumidityBetween 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 80 KiloPascal and 101 KiloPascal
Storage Environment TemperatureBetween -20 Degrees Celsius and 65 Degrees Celsius
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 80 KiloPascal and 101 KiloPascal
Handling Environment TemperatureBetween 5 Degrees Celsius and 32 Degrees Celsius
Handling Environment HumidityBetween 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 80 KiloPascal and 101 KiloPascal
Storage Environment TemperatureBetween -20 Degrees Celsius and 65 Degrees Celsius
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 80 KiloPascal and 101 KiloPascal
Handling Environment TemperatureBetween 5 Degrees Celsius and 32 Degrees Celsius
Handling Environment HumidityBetween 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 80 KiloPascal and 101 KiloPascal
Storage Environment TemperatureBetween -20 Degrees Celsius and 65 Degrees Celsius
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 80 KiloPascal and 101 KiloPascal
Handling Environment TemperatureBetween 5 Degrees Celsius and 32 Degrees Celsius
Handling Environment HumidityBetween 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 80 KiloPascal and 101 KiloPascal
Storage Environment TemperatureBetween -20 Degrees Celsius and 65 Degrees Celsius
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 80 KiloPascal and 101 KiloPascal
Handling Environment TemperatureBetween 5 Degrees Celsius and 32 Degrees Celsius
Handling Environment HumidityBetween 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 80 KiloPascal and 101 KiloPascal
Storage Environment TemperatureBetween -20 Degrees Celsius and 65 Degrees Celsius
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 80 KiloPascal and 101 KiloPascal
Handling Environment TemperatureBetween 5 Degrees Celsius and 32 Degrees Celsius
Handling Environment HumidityBetween 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 80 KiloPascal and 101 KiloPascal
Storage Environment TemperatureBetween -20 Degrees Celsius and 65 Degrees Celsius
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 80 KiloPascal and 101 KiloPascal
Handling Environment TemperatureBetween 5 Degrees Celsius and 32 Degrees Celsius
Handling Environment HumidityBetween 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 80 KiloPascal and 101 KiloPascal
Storage Environment TemperatureBetween -20 Degrees Celsius and 65 Degrees Celsius
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 80 KiloPascal and 101 KiloPascal
Handling Environment TemperatureBetween 5 Degrees Celsius and 32 Degrees Celsius
Handling Environment HumidityBetween 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 80 KiloPascal and 101 KiloPascal
Storage Environment TemperatureBetween -20 Degrees Celsius and 65 Degrees Celsius
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 80 KiloPascal and 101 KiloPascal
Handling Environment TemperatureBetween 5 Degrees Celsius and 32 Degrees Celsius
Handling Environment HumidityBetween 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 80 KiloPascal and 101 KiloPascal
Storage Environment TemperatureBetween -20 Degrees Celsius and 65 Degrees Celsius
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 80 KiloPascal and 101 KiloPascal
Handling Environment TemperatureBetween 5 Degrees Celsius and 32 Degrees Celsius
Handling Environment HumidityBetween 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 80 KiloPascal and 101 KiloPascal
Storage Environment TemperatureBetween -20 Degrees Celsius and 65 Degrees Celsius
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 80 KiloPascal and 101 KiloPascal
Handling Environment TemperatureBetween 5 Degrees Celsius and 32 Degrees Celsius
Handling Environment HumidityBetween 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 80 KiloPascal and 101 KiloPascal
Storage Environment TemperatureBetween -20 Degrees Celsius and 65 Degrees Celsius
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 80 KiloPascal and 101 KiloPascal
Handling Environment TemperatureBetween 5 Degrees Celsius and 32 Degrees Celsius
Handling Environment HumidityBetween 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 80 KiloPascal and 101 KiloPascal
Storage Environment TemperatureBetween -20 Degrees Celsius and 65 Degrees Celsius
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 80 KiloPascal and 101 KiloPascal
Handling Environment TemperatureBetween 5 Degrees Celsius and 32 Degrees Celsius
Handling Environment HumidityBetween 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 80 KiloPascal and 101 KiloPascal
Storage Environment TemperatureBetween -20 Degrees Celsius and 65 Degrees Celsius
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 80 KiloPascal and 101 KiloPascal
Handling Environment TemperatureBetween 5 Degrees Celsius and 32 Degrees Celsius
Handling Environment HumidityBetween 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 80 KiloPascal and 101 KiloPascal
Storage Environment TemperatureBetween -20 Degrees Celsius and 65 Degrees Celsius
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 80 KiloPascal and 101 KiloPascal
Handling Environment TemperatureBetween 5 Degrees Celsius and 32 Degrees Celsius
Handling Environment HumidityBetween 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 80 KiloPascal and 101 KiloPascal
Storage Environment TemperatureBetween -20 Degrees Celsius and 65 Degrees Celsius
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 80 KiloPascal and 101 KiloPascal
Handling Environment TemperatureBetween 5 Degrees Celsius and 32 Degrees Celsius
Handling Environment HumidityBetween 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 80 KiloPascal and 101 KiloPascal
Storage Environment TemperatureBetween -20 Degrees Celsius and 65 Degrees Celsius
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 80 KiloPascal and 101 KiloPascal
Handling Environment TemperatureBetween 5 Degrees Celsius and 32 Degrees Celsius
Handling Environment HumidityBetween 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 80 KiloPascal and 101 KiloPascal

Device Identifiers

Device Issuing AgencyDevice ID
GS100851540007147 [Primary]
GS100851540007154 [Package]
Package: Outer Case [1 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

BZQMonitor, Breathing Frequency

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-01-14
Device Publish Date2020-01-06

Devices Manufactured by RESPIRATORY MOTION INC.

00851540007147 - ExSpiron 2Xi2020-01-14A 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.
00851540007147 - ExSpiron 2Xi2020-01-14 A noninvasive device designed to continuously measure a patient's tidal volume, minute ventilation, and respiratory rate via imp
00851540007000 - ExSpiron 1Xi2018-07-06 A noninvasive device designed to continuously measure a patient's tidal volume, minute ventilation, and respiratory rate via imp
00851540007017 - ExSpiron 1Xi2018-07-06 Noninvasive, insulated, electrical cable designed to connect the ExSpiron 1Xi Monitor to the ExSpiron 1Xi PadSet.
00851540007024 - ExSpiron 1Xi2018-07-06 Insulated, reusable, medical grade electrical cord design to enable connection of the ExSpiron 1Xi to a mains electricity supply
00851540007048 - ExSpiron 1Xi2018-07-06 A non-sterile, single use electrode set designed to be adhered across a patient's chest and connected to the ExSpiron 1Xi Monito
00851540007055 - ExSpiron 1Xi2018-03-29 Assembly designed to be integrated into medical facility infrastructure in order to trigger a nurse call alarm system. Designed

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