Duns Number:439770017
Device Description: FIAB reusable praecordial suction chest electrodes for ECG, ball diameter Ø 33mm and rubbe FIAB reusable praecordial suction chest electrodes for ECG, ball diameter Ø 33mm and rubber ring diameter Ø 30mm. A113 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. The rings are made of rubber to improve patient’s comfort. 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 without Nickel
Catalog Number
A113
Brand Name
NA
Version/Model Number
A113
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
IKD
Product Code Name
Cable, Electrode
Public Device Record Key
32b7620b-73b4-4ac3-8f68-d49fdd12c296
Public Version Date
June 22, 2020
Public Version Number
1
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 |