Duns Number:013649151
Device Description: ECG lead cable designed for use with 3rd-generation wireless ECG module and Neonatal Quadt ECG lead cable designed for use with 3rd-generation wireless ECG module and Neonatal Quadtrodes (IEC coded leads.)
Catalog Number
989803193771
Brand Name
MR Patient Care Neonatal ECG 3.0 Cable IEC
Version/Model Number
Neonatal ECG 3.0 Cable IEC
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
d462fdc1-1a04-40d2-bd80-66140ea72cbb
Public Version Date
August 22, 2022
Public Version Number
3
DI Record Publish Date
May 14, 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 |