Duns Number:439770017
Device Description: Disposable ECG monitoring electrodes have features that make them absolutely r Disposable ECG monitoring electrodes have features that make them absolutely reliable during long monitoring ECG recording (not longer than 72 hours). F9053PRRM/80 model are oval-shaped electrodes, 20x15mm dimensions, equipped with 80cm long wire and 4mm socket, pre-gelled and they can be easily connected to the ECG monitor, avoiding pressure on the skin. The external layer in waterproof medical grade PE foam protects the skin beneath the electrode from air and contaminating fluids.F9053PRRM/80 model is radiotranslucent, therefore it allows the user to perform radiographic procedures without removing the electrode.
Catalog Number
F9053PRRM/80
Brand Name
NA
Version/Model Number
F9053PRRM/80
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
40ccb049-e146-4153-bd60-298d1659109f
Public Version Date
November 11, 2020
Public Version Number
2
DI Record Publish Date
June 13, 2020
Package DI Number
18054242448426
Quantity per Package
5
Contains DI Package
08054242448429
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 42 |