Duns Number:341318999
Device Description: Norav Telemetry ECG Acquisition Device NR-314-T for Telemetry 3 Channel Resting-ECG Monito Norav Telemetry ECG Acquisition Device NR-314-T for Telemetry 3 Channel Resting-ECG Monitoring with AHA type labelling.
Catalog Number
NR314T-D-00U-04
Brand Name
Norav NR Series
Version/Model Number
NR-314-T
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
MWI
Product Code Name
Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)
Public Device Record Key
5534645e-9838-4651-90f3-e9adcfba5df1
Public Version Date
July 17, 2020
Public Version Number
1
DI Record Publish Date
July 09, 2020
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 |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 46 |