Duns Number:439770017
Device Description: Reusable praecordial suction chest electrodes for ECG, rubber ring diameter Ø 24mm and ele Reusable praecordial suction chest electrodes for ECG, rubber ring diameter Ø 24mm and electrode diameter Ø 14mm. F9009ULTRA model has features that make it absolutely reliable during signal recording with all different ECG devices on the market. The plastic metallic part is silver coated (Ag/AgCl) 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 suction chest electrodes thanks toelastic connections, can be tapped to all ECG devices and monitors with patient cables which have 4mm plug connections. The product is Latex-free and Nickel-free.
Catalog Number
F9009ULTRA
Brand Name
NA
Version/Model Number
F9009ULTRA
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
250c25ef-0ae1-4e12-b7ba-b42452c9bbe5
Public Version Date
November 11, 2020
Public Version Number
2
DI Record Publish Date
June 13, 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 |