Duns Number:790605856
Device Description: Disposable, adult, 5-lead ECG monitoring, solid gel electrodes with pre-attached 39 inch ( Disposable, adult, 5-lead ECG monitoring, solid gel electrodes with pre-attached 39 inch (100cm) non-shielded, radiolucent, carbon, AAMI color-coded lead wires. Silver/silver chloride (Ag/AgCl) sensor, repositionable. Electrode is rectangular in shape and is 30 mm x 45 mm in size. Packaging is 1 set (5pcs.) per pouch or 60 sets (300pcs) per box. Sold in box quantities only. For use with all adult ECG monitors; NOT for use with Philips Telemetry Transmitters and Transceivers.
Catalog Number
989803156261
Brand Name
ECG Electrodes
Version/Model Number
DISP RAD 5 LEADWIRE ELECT SET, AAMI
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
abfad3d8-c5b7-4e49-aa34-cedb2f8a6781
Public Version Date
March 04, 2022
Public Version Number
6
DI Record Publish Date
April 17, 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 |