Duns Number:439770017
Device Description: Reusable praecordial suction chest electrodes for ECG, metallic part Ø 24mm and ball diame Reusable praecordial suction chest electrodes for ECG, metallic part Ø 24mm and ball diameter Ø 33mm. F9009PLUS model has features that make it absolutely reliable during signal recording with all different ECG devices on the market. The metallic part is silver coated (Ag/AgCl) allowing a safe and clear signal transmission. FIAB suction chest electrodes thanks to screw and clip connections, can be tapped to all ECG devices and monitors with patient cables which have plug or snap connections. The product is Latex-free and Nickel-free.
Catalog Number
F9009PLUS
Brand Name
NA
Version/Model Number
F9009PLUS
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
b8abe612-aaef-4c98-8644-1653584f0db5
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 |