Duns Number:514773159
Device Description: Norav PC-ECG 1200 Series wireless Acquisition Device for Resting ECG with AHA type labelli Norav PC-ECG 1200 Series wireless Acquisition Device for Resting ECG with AHA type labelling.
Catalog Number
BLUECG-D-00U-01
Brand Name
Wireless BT 12 lead resting ECG.
Version/Model Number
Blue ECG
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
074b5ac3-c62a-4c94-bf99-5f42a3e524f8
Public Version Date
September 30, 2019
Public Version Number
5
DI Record Publish Date
October 21, 2016
Package DI Number
7290110250713
Quantity per Package
1
Contains DI Package
07290110250607
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 213 |