Duns Number:514773159
Device Description: Kit includes: Norav Ambulatory ECG Recording Unit NR2 (UDI: 07290110254537) for Ambulatory Kit includes: Norav Ambulatory ECG Recording Unit NR2 (UDI: 07290110254537) for Ambulatory ECG Monitoring (Holter-ECG), 3 ch., max. 14 days and AHA type labelling; Input cable with 7 Patient leads AHA type and Snap connectors.
Catalog Number
NR314-K-00-U-S7-02
Brand Name
Norav NR Series
Version/Model Number
NR314 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
MWJ
Product Code Name
Electrocardiograph, Ambulatory (Without Analysis)
Public Device Record Key
5432f77a-0d1e-4c1b-abcd-a9d05b0f22d2
Public Version Date
November 08, 2019
Public Version Number
2
DI Record Publish Date
September 30, 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 |