Duns Number:439770017
Device Description: Disposable oval-shaped ECG electrodes with liquid gel, Silver/Silver Chloride(SSC) Disposable oval-shaped ECG electrodes with liquid gel, Silver/Silver Chloride(SSC) sensor, 52x32mm dimensions and with 4mm socket . These electrodes dimensions have features that make them absolutely reliable during signal recording in rest tests, with a direct application onto the skin. The SSC sensor permits a reliable and stable recording and off-centered configuration allows a better quality of ECG signal and reduces artifacts. They comply with ANSI/AAMI EC12:2000 permitting the signal recovery after defibrillator discharge. After opening, the pouch can be folded to ensure a better preservation of the electrodes that remain inside. The products are latex-free.
Catalog Number
F2017/4FL
Brand Name
NA
Version/Model Number
F2017/4FL
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
77c65c8f-dbf1-4674-aef7-52f03985205a
Public Version Date
November 11, 2020
Public Version Number
2
DI Record Publish Date
June 12, 2020
Package DI Number
18054953341245
Quantity per Package
15
Contains DI Package
08054953341248
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 |