Duns Number:790605856
Device Description: Neonatal/Pediatric Solid Gel Electrode Solid adhesive gel, ECG monitoring Silver/silver-ch Neonatal/Pediatric Solid Gel Electrode Solid adhesive gel, ECG monitoring Silver/silver-chloride sensor. 22 mm x 33 mm rectangular electrode. 3 electrodes/pk, 30 electrodes/pouch, 300 electrodes/case.
Catalog Number
13951C
Brand Name
ECG Cables and Leadsets
Version/Model Number
NEONATAL/PEDIATRIC SOLID GEL ELECTRODE
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
Yes
Prescription Use (Rx)
-
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
e31bb0e6-a9ab-4f8d-80ab-606ed3b85f56
Public Version Date
August 24, 2022
Public Version Number
10
DI Record Publish Date
February 03, 2017
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 |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 7 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 323 |
| 3 | A medical device with high risk that requires premarket approval | 36 |
| U | Unclassified | 1 |