Duns Number:514773159
Device Description: Kit includes: PC-ECG 1200T with Trigger (UDI: 07290110252656) and selectable channel, 5V o Kit includes: PC-ECG 1200T with Trigger (UDI: 07290110252656) and selectable channel, 5V operating voltage; Medical Grade Power Supply 110V to 5V for US market Input Cable with 3 Patient Leads AHA Type and Clip Connectors
Catalog Number
1200T3-K-00-U-C3-07
Brand Name
Norav 1200 Series PC-ECG
Version/Model Number
1200T 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
5823849c-2978-4def-b46e-0bdf34b28166
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 |