Duns Number:514773159
Device Description: The ECG-USB1 device provides a single channel ECG for host systems that require an externa The ECG-USB1 device provides a single channel ECG for host systems that require an external unit in order to add ECG\Respiration capabilities in an easy and fast way to their platform. The host owner should write its own software application that communicates with the device via USB port using the Norav USB driver and SDK.
Catalog Number
ECG Module
Brand Name
ECG
Version/Model Number
ECGUSB1D-EX-FW11/B
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
b182dec0-c90c-4841-b0ad-21f3df33c757
Public Version Date
October 30, 2020
Public Version Number
4
DI Record Publish Date
October 13, 2016
Package DI Number
07290110250010
Quantity per Package
1
Contains DI Package
07290110251062
Package Discontinue Date
October 30, 2020
Package Status
Not in Commercial Distribution
Package Type
Carton Box
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 213 |