Duns Number:439770017
Device Description: F9057PRM model is a disposable round-shaped ECG monitoring electrodes have features that m F9057PRM model is a disposable round-shaped ECG monitoring electrodes have features that make them absolutely reliable during long monitoring ECG recording (not longer than 72 hours). F9057PRM is pre-gelled, Ø 32mm, equipped with 50cm long wire and DIN 42802-1 1.5mm socket. The external surface is made of non woven fabric. The fabric is made of plastic polyethylene fiber (and not natural fiber) that guarantees the transpiration of the skin, but at the same time the resistance to liquids with which they may come into contact during their use. Adult and Pediatric model.F9057PRM model is radiotranslucent, therefore it allows the user to perform radiographic procedures without removing the electrode.
Catalog Number
F9057PRM
Brand Name
NA
Version/Model Number
F9057PRM
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
338a21fb-fb57-4e8a-875c-b3133bab37fa
Public Version Date
November 11, 2020
Public Version Number
2
DI Record Publish Date
June 13, 2020
Package DI Number
18054953341061
Quantity per Package
50
Contains DI Package
08054953341064
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 |