Duns Number:963613745
Device Description: A non-sterile, single use electrode set designed to be adhered across a patient's chest an 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.
Catalog Number
RMI-51110
Brand Name
ExSpiron 1Xi
Version/Model Number
PadSet
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
Yes
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,K130170,K130170,K130170,K130170
Product Code
BZK
Product Code Name
Spirometer, Monitoring (W/Wo Alarm)
Public Device Record Key
e716bb64-c9f8-47da-8833-8c093acc0da5
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
September 24, 2016
Package DI Number
20851540007042
Quantity per Package
100
Contains DI Package
00851540007048
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Case