Duns Number:341318999
Device Description: Kit includes: Single Channel ECG Acquisition Module (DI no.: 04260498566891) for integrat Kit includes: Single Channel ECG Acquisition Module (DI no.: 04260498566891) for integration in other Medical Devices. ECG Input Cable, 3 leads, IEC color coding Software Package on CDSpecial edition for GE Health Care.
Catalog Number
ECGUSB1DEX-K-00-EC3-12
Brand Name
Norav 1200 Series
Version/Model Number
ECGUSB1DEX 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
89ddf420-9606-4f18-9b91-d8f11023518c
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 |