Duns Number:514773159
Device Description: Norav 1200 Series PC-ECG Software Kit with the following Option(s): - I3 = Rest Norav 1200 Series PC-ECG Software Kit with the following Option(s): - I3 = Resting-ECG Measurement and Interpretation MEANS (Univ. of Rotterdam, NL) - Network Capability for I3 The Kit includes: Software Protection Key - "HASP-Key" Software on Installation Medium (CD or USB-Stick).
Catalog Number
HASP-SW-K-I3-N-02
Brand Name
Norav 1200 Series PC-ECG
Version/Model Number
SW I3-N
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
f9f23839-7299-4496-b0f3-822fa7ec52c5
Public Version Date
October 10, 2019
Public Version Number
1
DI Record Publish Date
October 02, 2019
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. | 213 |