Duns Number:439770017
Device Description: Disposable ECG monitoring electrodes have features that make them absolutely reliable duri Disposable ECG monitoring electrodes have features that make them absolutely reliable during long monitoring ECG recording (not longer than 72 hours). F9058P model is pre-gelled, Ø 32mm, equipped with 50cm long wire with DIN 42802-1 1.5mm socket.The external layer in waterproof medical grade PE foam protects the skin beneath the electrode from air and contaminating fluids.
Catalog Number
F9058P
Brand Name
NA
Version/Model Number
F9058P
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
aa2c5997-b783-437c-9114-0be8f4557edd
Public Version Date
November 18, 2020
Public Version Number
2
DI Record Publish Date
June 13, 2020
Package DI Number
28033003260368
Quantity per Package
50
Contains DI Package
08033003260364
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 |