Duns Number:963613745
Device Description: Insulated, reusable, medical grade electrical cord design to enable connection of the ExSp Insulated, reusable, medical grade electrical cord design to enable connection of the ExSpiron 1Xi to a mains electricity supply socket, with a NEMA 5-15P plug and an IEC 60320-C13 connector at either end.
Catalog Number
RMI-51250
Brand Name
ExSpiron 1Xi
Version/Model Number
Power Cord, 10'
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)
-
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
96abe4f9-7b2b-437b-b2e0-360f4feda6cf
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
September 24, 2016
Package DI Number
00851540007109
Quantity per Package
1
Contains DI Package
00851540007024
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Outer Case