Duns Number:439770017
Device Description: Reusable peripheral clamp electrodes for ECG, 20x85mm clamp dimensions. F9023PLUS has feat Reusable peripheral clamp electrodes for ECG, 20x85mm clamp dimensions. F9023PLUS has features that make it absolutely reliable during signal recording with all different ECG devices on the market.The electrode metallic part is made of silver coated material, allowing a safe and clear signal transmission.The treatment allows the recovery of the signal after defibrillation discharge in compliance with EN60601-2-25 regulation. FIAB peripheral electrodes, thanks to screw and clip connections, can be connected to all ECG devices and monitors with patient cable which have plug or snap connections. The product is latex-free and Nickel-free
Catalog Number
F9023PLUS
Brand Name
NA
Version/Model Number
F9023PLUS
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
-
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
0d7194e5-96fe-49b6-a93b-b6d222ec20e2
Public Version Date
November 11, 2020
Public Version Number
2
DI Record Publish Date
June 12, 2020
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
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 |