Duns Number:305682023
Device Description: ECG Electrodes Solid Gel Stud Connector
Catalog Number
NF-00-S/12
Brand Name
BlueSensor NFECG Electrodes
Version/Model Number
NF-00-S/12
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"
Yes
For Single-Use
Yes
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
DRX
Product Code Name
Electrode, electrocardiograph
Public Device Record Key
09fa3bca-53d1-4b3b-835a-bf87542e1f8e
Public Version Date
March 29, 2018
Public Version Number
2
DI Record Publish Date
September 21, 2016
Package DI Number
05707480021918
Quantity per Package
100
Contains DI Package
05707480022137
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 1 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 309 |