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 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.
Catalog Number
-
Brand Name
ExSpiron 2Xi
Version/Model Number
RMI-54000
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
K192595,K192595
Product Code
BZK
Product Code Name
Spirometer, Monitoring (W/Wo Alarm)
Public Device Record Key
ec43e40b-7201-43eb-aada-df2ba4e71109
Public Version Date
January 14, 2020
Public Version Number
1
DI Record Publish Date
January 06, 2020
Package DI Number
00851540007154
Quantity per Package
1
Contains DI Package
00851540007147
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Outer Case