Duns Number:341318999
Device Description: Kit includes: PC-ECG 1200W (UDI: 04260498565047) wireless Stress-Test Kit (Rev.02); Kit includes: PC-ECG 1200W (UDI: 04260498565047) wireless Stress-Test Kit (Rev.02); PC-ECG 1200WR (UDI: 04260498566907) Receiver Unit Input cable with ten leads IEC type and Clip connectors.Special edition for GE Health Care.
Catalog Number
1200W2-K-04-E-C10-03
Brand Name
Norav 1200 Series PC-ECG
Version/Model Number
1200W 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
67b44b94-58b9-4d52-b913-3d906dbd5577
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 |