Duns Number:439770017
Device Description: F9047/4FL model is ECG disposable pregelled electrode with liquid gel, 28x44mm dimension F9047/4FL model is ECG disposable pregelled electrode with liquid gel, 28x44mm dimension and equipped with 4mm plug connection. The ECG electrode have features that make them absolutely reliable during signal recording. F9047/4FL model is used also recording in stress test and for Holter monitoring. They are compatible with different ECG devices on the market. 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
F9047/4FL
Brand Name
NA
Version/Model Number
F9047/4FL
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
3633bd16-6e21-449d-b136-e2bd6dddb420
Public Version Date
November 11, 2020
Public Version Number
2
DI Record Publish Date
June 13, 2020
Package DI Number
18054242440093
Quantity per Package
20
Contains DI Package
08054242440096
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 |