Duns Number:013649151
Device Description: ROHS-compliant wireless SpO2 module for use with Expression monitors and wireless gating s ROHS-compliant wireless SpO2 module for use with Expression monitors and wireless gating systems.
Catalog Number
989803183541
Brand Name
Expression MR Wireless SpO2 Patient Module
Version/Model Number
Wireless SPO2 Patient Module
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
Labeling does not contain MRI Safety Information
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
980fb579-7bf4-41fe-9025-2ee10f6a7944
Public Version Date
February 28, 2022
Public Version Number
8
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 |