ExSpiron 1Xi RMI-51000

GUDID 00851540007000

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.

RESPIRATORY MOTION INC.

Monitoring spirometer, electrical

• Primary Device ID: 00851540007000
• NIH Device Record Key: 69595327-ffb7-4311-a597-46ba45621cff
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ExSpiron 1Xi
• Version Model Number: Monitor
• Catalog Number: RMI-51000
• Company DUNS: 963613745
• Company Name: RESPIRATORY MOTION INC.
• Device Count: 1
• DM Exempt: true
• Pre-market Exempt: false
• MRI Safety Status: MR Unsafe
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 7816097829
• Email: support@respiratorymotion.com
• Phone: 2399204288
• Email: info.us@senzime.com
• Phone: 2399204288
• Email: info.us@senzime.com
• Phone: 2399204288
• Email: info.us@senzime.com
• Phone: 2399204288
• Email: info.us@senzime.com
• Phone: 2399204288
• Email: info.us@senzime.com
• Phone: 2399204288
• Email: info.us@senzime.com
• Phone: 2399204288
• Email: info.us@senzime.com
• Phone: 2399204288
• Email: info.us@senzime.com
• Phone: 2399204288
• Email: info.us@senzime.com
• Phone: 2399204288
• Email: info.us@senzime.com
• Phone: 2399204288
• Email: info.us@senzime.com
• Phone: 2399204288
• Email: info.us@senzime.com
• Phone: 2399204288
• Email: info.us@senzime.com
• Phone: 2399204288
• Email: info.us@senzime.com
• Phone: 2399204288
• Email: info.us@senzime.com
• Phone: 2399204288
• Email: info.us@senzime.com
• Phone: 2399204288
• Email: info.us@senzime.com
• Phone: 2399204288
• Email: info.us@senzime.com
• Phone: 2399204288
• Email: info.us@senzime.com
• Phone: 2399204288
• Email: info.us@senzime.com
• Phone: 2399204288
• Email: info.us@senzime.com
• Phone: 2399204288
• Email: info.us@senzime.com
• Phone: 2399204288
• Email: info.us@senzime.com
• Phone: 2399204288
• Email: info.us@senzime.com
• Phone: 2399204288
• Email: info.us@senzime.com
• Phone: 2399204288
• Email: info.us@senzime.com
• Phone: 2399204288
• Email: info.us@senzime.com
• Phone: 2399204288
• Email: info.us@senzime.com
• Phone: 2399204288
• Email: info.us@senzime.com
• Phone: 2399204288
• Email: info.us@senzime.com
• Phone: 2399204288
• Email: info.us@senzime.com
• Phone: 2399204288
• Email: info.us@senzime.com
• Phone: 2399204288
• Email: info.us@senzime.com
• Phone: 2399204288
• Email: info.us@senzime.com
• Phone: 2399204288
• Email: info.us@senzime.com
• Phone: 800-213-1324
• Email: info.us@senzime.com
• Phone: 800-213-1324
• Email: info.us@senzime.com
• Phone: 800-213-1324
• Email: info.us@senzime.com
• Phone: 800-213-1324
• Email: info.us@senzime.com
• Phone: 800-213-1324
• Email: info.us@senzime.com
• Phone: 800-213-1324
• Email: info.us@senzime.com
• Phone: 800-213-1324
• Email: info.us@senzime.com
• Phone: 800-213-1324
• Email: info.us@senzime.com
• Phone: 800-213-1324
• Email: info.us@senzime.com
• Phone: 800-213-1324
• Email: info.us@senzime.com
• Phone: 800-213-1324
• Email: info.us@senzime.com
• Phone: 800-213-1324
• Email: info.us@senzime.com
• Phone: 800-213-1324
• Email: info.us@senzime.com
• Phone: 800-213-1324
• Email: info.us@senzime.com
• Phone: 800-213-1324
• Email: info.us@senzime.com
• Phone: 800-213-1324
• Email: info.us@senzime.com
• Phone: 800-213-1324
• Email: info.us@senzime.com

Operating and Storage Conditions

• Handling Environment Temperature: Between 5 Degrees Celsius and 32 Degrees Celsius
• Handling Environment Temperature: Between 5 Degrees Celsius and 32 Degrees Celsius
• Handling Environment Temperature: Between 5 Degrees Celsius and 32 Degrees Celsius
• Handling Environment Temperature: Between 5 Degrees Celsius and 32 Degrees Celsius
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Handling Environment Humidity: Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 65 Degrees Celsius
• Handling Environment Temperature: Between 5 Degrees Celsius and 32 Degrees Celsius
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Handling Environment Humidity: Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 65 Degrees Celsius
• Handling Environment Temperature: Between 5 Degrees Celsius and 32 Degrees Celsius
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Handling Environment Humidity: Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 65 Degrees Celsius
• Handling Environment Temperature: Between 5 Degrees Celsius and 32 Degrees Celsius
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Handling Environment Humidity: Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 65 Degrees Celsius
• Handling Environment Temperature: Between 5 Degrees Celsius and 32 Degrees Celsius
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Handling Environment Humidity: Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 65 Degrees Celsius
• Handling Environment Temperature: Between 5 Degrees Celsius and 32 Degrees Celsius
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Handling Environment Humidity: Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 65 Degrees Celsius
• Handling Environment Temperature: Between 5 Degrees Celsius and 32 Degrees Celsius
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Handling Environment Humidity: Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 65 Degrees Celsius
• Handling Environment Temperature: Between 5 Degrees Celsius and 32 Degrees Celsius
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Handling Environment Humidity: Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 65 Degrees Celsius
• Handling Environment Temperature: Between 5 Degrees Celsius and 32 Degrees Celsius
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Handling Environment Humidity: Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 65 Degrees Celsius
• Handling Environment Temperature: Between 5 Degrees Celsius and 32 Degrees Celsius
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Handling Environment Humidity: Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 65 Degrees Celsius
• Handling Environment Temperature: Between 5 Degrees Celsius and 32 Degrees Celsius
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Handling Environment Humidity: Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 65 Degrees Celsius
• Handling Environment Temperature: Between 5 Degrees Celsius and 32 Degrees Celsius
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Handling Environment Humidity: Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 65 Degrees Celsius
• Handling Environment Temperature: Between 5 Degrees Celsius and 32 Degrees Celsius
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Handling Environment Humidity: Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 65 Degrees Celsius
• Handling Environment Temperature: Between 5 Degrees Celsius and 32 Degrees Celsius
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Handling Environment Humidity: Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 65 Degrees Celsius
• Handling Environment Temperature: Between 5 Degrees Celsius and 32 Degrees Celsius
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Handling Environment Humidity: Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 65 Degrees Celsius
• Handling Environment Temperature: Between 5 Degrees Celsius and 32 Degrees Celsius
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Handling Environment Humidity: Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 65 Degrees Celsius
• Handling Environment Temperature: Between 5 Degrees Celsius and 32 Degrees Celsius
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Handling Environment Humidity: Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 65 Degrees Celsius
• Handling Environment Temperature: Between 5 Degrees Celsius and 32 Degrees Celsius
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Handling Environment Humidity: Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 65 Degrees Celsius
• Handling Environment Temperature: Between 5 Degrees Celsius and 32 Degrees Celsius
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Handling Environment Humidity: Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 65 Degrees Celsius
• Handling Environment Temperature: Between 5 Degrees Celsius and 32 Degrees Celsius
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Handling Environment Humidity: Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 65 Degrees Celsius
• Handling Environment Temperature: Between 5 Degrees Celsius and 32 Degrees Celsius
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Handling Environment Humidity: Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 65 Degrees Celsius
• Handling Environment Temperature: Between 5 Degrees Celsius and 32 Degrees Celsius
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Handling Environment Humidity: Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 65 Degrees Celsius
• Handling Environment Temperature: Between 5 Degrees Celsius and 32 Degrees Celsius
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Handling Environment Humidity: Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 65 Degrees Celsius
• Handling Environment Temperature: Between 5 Degrees Celsius and 32 Degrees Celsius
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Handling Environment Humidity: Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 65 Degrees Celsius
• Handling Environment Temperature: Between 5 Degrees Celsius and 32 Degrees Celsius
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Handling Environment Humidity: Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 65 Degrees Celsius
• Handling Environment Temperature: Between 5 Degrees Celsius and 32 Degrees Celsius
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Handling Environment Humidity: Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 65 Degrees Celsius
• Handling Environment Temperature: Between 5 Degrees Celsius and 32 Degrees Celsius
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Handling Environment Humidity: Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 65 Degrees Celsius
• Handling Environment Temperature: Between 5 Degrees Celsius and 32 Degrees Celsius
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Handling Environment Humidity: Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 65 Degrees Celsius
• Handling Environment Temperature: Between 5 Degrees Celsius and 32 Degrees Celsius
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Handling Environment Humidity: Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 65 Degrees Celsius
• Handling Environment Temperature: Between 5 Degrees Celsius and 32 Degrees Celsius
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Handling Environment Humidity: Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 65 Degrees Celsius
• Handling Environment Temperature: Between 5 Degrees Celsius and 32 Degrees Celsius
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Handling Environment Humidity: Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 65 Degrees Celsius
• Handling Environment Temperature: Between 5 Degrees Celsius and 32 Degrees Celsius
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Handling Environment Humidity: Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 65 Degrees Celsius
• Handling Environment Temperature: Between 5 Degrees Celsius and 32 Degrees Celsius
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Handling Environment Humidity: Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 65 Degrees Celsius
• Handling Environment Temperature: Between 5 Degrees Celsius and 32 Degrees Celsius
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Handling Environment Humidity: Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 65 Degrees Celsius
• Handling Environment Temperature: Between 5 Degrees Celsius and 32 Degrees Celsius
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Handling Environment Humidity: Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 65 Degrees Celsius
• Handling Environment Temperature: Between 5 Degrees Celsius and 32 Degrees Celsius
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Handling Environment Humidity: Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 65 Degrees Celsius
• Handling Environment Temperature: Between 5 Degrees Celsius and 32 Degrees Celsius
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Handling Environment Humidity: Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 65 Degrees Celsius
• Handling Environment Temperature: Between 5 Degrees Celsius and 32 Degrees Celsius
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Handling Environment Humidity: Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 65 Degrees Celsius
• Handling Environment Temperature: Between 5 Degrees Celsius and 32 Degrees Celsius
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Handling Environment Humidity: Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 65 Degrees Celsius
• Handling Environment Temperature: Between 5 Degrees Celsius and 32 Degrees Celsius
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Handling Environment Humidity: Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 65 Degrees Celsius
• Handling Environment Temperature: Between 5 Degrees Celsius and 32 Degrees Celsius
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Handling Environment Humidity: Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 65 Degrees Celsius
• Handling Environment Temperature: Between 5 Degrees Celsius and 32 Degrees Celsius
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Handling Environment Humidity: Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 65 Degrees Celsius
• Handling Environment Temperature: Between 5 Degrees Celsius and 32 Degrees Celsius
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Handling Environment Humidity: Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 65 Degrees Celsius
• Handling Environment Temperature: Between 5 Degrees Celsius and 32 Degrees Celsius
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Handling Environment Humidity: Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 65 Degrees Celsius
• Handling Environment Temperature: Between 5 Degrees Celsius and 32 Degrees Celsius
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Handling Environment Humidity: Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 65 Degrees Celsius
• Handling Environment Temperature: Between 5 Degrees Celsius and 32 Degrees Celsius
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Handling Environment Humidity: Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 65 Degrees Celsius
• Handling Environment Temperature: Between 5 Degrees Celsius and 32 Degrees Celsius
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Handling Environment Humidity: Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 65 Degrees Celsius
• Handling Environment Temperature: Between 5 Degrees Celsius and 32 Degrees Celsius
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Handling Environment Humidity: Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 65 Degrees Celsius
• Handling Environment Temperature: Between 5 Degrees Celsius and 32 Degrees Celsius
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Handling Environment Humidity: Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 65 Degrees Celsius
• Handling Environment Temperature: Between 5 Degrees Celsius and 32 Degrees Celsius
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Handling Environment Humidity: Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 65 Degrees Celsius
• Handling Environment Temperature: Between 5 Degrees Celsius and 32 Degrees Celsius
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Handling Environment Humidity: Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 65 Degrees Celsius
• Handling Environment Temperature: Between 5 Degrees Celsius and 32 Degrees Celsius
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Handling Environment Humidity: Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 65 Degrees Celsius
• Handling Environment Temperature: Between 5 Degrees Celsius and 32 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00851540007000 [Primary]
GS1	00851540007031 [Package]; Package: Outer Case [1 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K130170

FDA Product Code

• BZK: Spirometer, Monitoring (W/Wo Alarm)

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-09-24

On-Brand Devices [ExSpiron 1Xi]

• 00851540007055: Assembly designed to be integrated into medical facility infrastructure in order to trigger a nu
• 00851540007048: A non-sterile, single use electrode set designed to be adhered across a patient's chest and conn
• 00851540007024: Insulated, reusable, medical grade electrical cord design to enable connection of the ExSpiron 1
• 00851540007017: Noninvasive, insulated, electrical cable designed to connect the ExSpiron 1Xi Monitor to the ExS
• 00851540007000: A noninvasive device designed to continuously measure a patient's tidal volume, minute ventilati