Duns Number:013649151
Device Description: 3rd-Generation wireless SpO2 module for Expression MRI patient monitors (Networks 6-10).
Catalog Number
989803194331
Brand Name
Expression MR Wireless SpO2 Patient Module (Gen 3)6-10
Version/Model Number
Wireless SpO2 3.0 Module (Networks 6-10)
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
MWI
Product Code Name
MONITOR,PHYSIOLOGICAL,PATIENT(WITHOUT ARRHYTHMIA DETECTION OR ALARMS)
Public Device Record Key
7cc72769-46ba-44fd-9cc6-ac86d5a9833b
Public Version Date
February 28, 2022
Public Version Number
10
DI Record Publish Date
September 29, 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 |