Duns Number:013649151
Device Description: ECG Leadwire Set designed for use with the Expression MRI Patient Monitor when utlizing th ECG Leadwire Set designed for use with the Expression MRI Patient Monitor when utlizing the system's Advanced ECG Gradient Filter. Compatible with the CV Quadtrode 9371A.
Catalog Number
989803170121
Brand Name
MR Patient Care Long Wide ECG 2.0 Cable AAMI
Version/Model Number
Long Wide ECG 2.0 Cable AAMI
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
37aed5d1-b773-441f-95e6-a0d7b25344c9
Public Version Date
August 22, 2022
Public Version Number
4
DI Record Publish Date
May 13, 2021
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 |