Duns Number:341318999
Device Description: Kit includes: PC-ECG 1200HR (UDI: 04260498566822) for High Resolution Resting-ECG and Stre Kit includes: PC-ECG 1200HR (UDI: 04260498566822) for High Resolution Resting-ECG and Stress-Test ECG recordings with IEC type labelling. Input cable with 10 Patient leads IEC type and Snap connectors.
Catalog Number
1200HR-K-00-E-S10-04
Brand Name
Norav 1200 Series PC-ECG
Version/Model Number
1200HR Kit
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
5fc28a80-6d70-467a-8b58-7c378a76068b
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 |