Duns Number:013649151
Device Description: Essential MRI Patient Vital Signs Monitor for monitoring Pulse Oximetry (SpO2) in the MRI Essential MRI Patient Vital Signs Monitor for monitoring Pulse Oximetry (SpO2) in the MRI environment. Key Features include: Communicates wirelessly with Invivo. Expression or Precess 2nd-Gen wSpO2 Modules for seamless patient transitions, Touch Screen Display Unrestricted MRI Gauss Rating, Lightweight portable Alarm light All parameters support Adult, Pediatric, infant and Neonatal applications,8-Hour Smart Battery Technology, Environmentally friendly Green, Flexible mounting options. One (1) year limited warranty and factory service for hardware
Catalog Number
865353
Brand Name
Essential MRI Patient Monitor (Model 865353)
Version/Model Number
Essential MRI Patient Monitor
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
MR Conditional
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
-
Product Code
DQA
Product Code Name
Oximeter
Public Device Record Key
4f150e79-c944-4209-bfb8-494e42d544a6
Public Version Date
March 09, 2022
Public Version Number
5
DI Record Publish Date
September 30, 2016
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 17 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 650 |
| U | Unclassified | 4 |