Duns Number:514773159
Device Description: PC-ECG Acquisition Device with Trigger, 5V operating voltage, MGSpecial edition for GE Hea PC-ECG Acquisition Device with Trigger, 5V operating voltage, MGSpecial edition for GE Health Care
Catalog Number
1200T3-D-00-02
Brand Name
Norav 1200 Series PC-ECG
Version/Model Number
1200T
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
60776c64-334b-4b83-b6b2-7c20dfcf8e55
Public Version Date
September 30, 2019
Public Version Number
1
DI Record Publish Date
September 22, 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 |