Duns Number:514773159
Device Description: Kit includes: PC-ECG 1200HR (UDI: 07290110255497) for High Resolution Resting-ECG and Stre Kit includes: PC-ECG 1200HR (UDI: 07290110255497) for High Resolution Resting-ECG and Stress-Test ECG recordings with ECG-Trigger Output and AHA type labelling. Input cable with 10 Patient leads AHA type and Snap connectors.
Catalog Number
1200HRT-K-00-U-S10-03
Brand Name
Norav 1200 Series PC-ECG
Version/Model Number
1200HRT 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
af1d0147-5fcd-49cf-ac27-50752a63ac86
Public Version Date
June 11, 2020
Public Version Number
1
DI Record Publish Date
June 03, 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. | 213 |