Duns Number:439770017
Device Description: Reusable light electrodes for ECG, active surface 113 mm³ and cable length 28 cm. Reusable light electrodes for ECG, active surface 113 mm³ and cable length 28 cm. F9028 model has features that make it absolutely reliable during signal recording with all different ECG on the market. Cable and metallic recording electrode are very light and can be easily positioned using conductive gel. ECG signal is extremely clear thanks to beryllium of which the electrode is made of. FIAB light electrodes can be tapped to all ECGs and monitors with Ø 4 mm snap cable
Catalog Number
F9028
Brand Name
NA
Version/Model Number
F9028
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
7ec17500-ca6d-4e96-a6a1-fdcec4efbe1d
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 |