Duns Number:963613745
Device Description: A noninvasive device designed to continuously measure a patient's tidal volume, minute ven 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.
Catalog Number
RMI-51000
Brand Name
ExSpiron 1Xi
Version/Model Number
Monitor
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
MR Unsafe
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)
-
Device labeled as "Not made with natural rubber latex"
-
For Single-Use
-
Prescription Use (Rx)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K130170,K130170
Product Code
BZK
Product Code Name
Spirometer, Monitoring (W/Wo Alarm)
Public Device Record Key
69595327-ffb7-4311-a597-46ba45621cff
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
September 24, 2016
Package DI Number
00851540007031
Quantity per Package
1
Contains DI Package
00851540007000
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Outer Case