Duns Number:439770017
Device Description: Disposable multifunction electrodes for external defibrillation, transthoracic synchronize Disposable multifunction electrodes for external defibrillation, transthoracic synchronized cardioversion, transcutaneous cardiac stimulation and ECG monitoring. Designed for direct connection to cables and defibrillators, they are characterized by a low impedance and a reduced stimulation threshold, with an excellent adaptability to the patient’s skin. The protective foam insulator and the safety plug eliminate every risk of electric micro-shock. Electrodes equipped with connector for defibrillators NIHON KOHDEN. Adult version.
Catalog Number
U7955
Brand Name
NA
Version/Model Number
U7955
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"
-
For Single-Use
Yes
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
K103783,K103783
Product Code
LDD
Product Code Name
Dc-Defibrillator, Low-Energy, (Including Paddles)
Public Device Record Key
f56f276e-ada0-4aa5-82fd-95e60797ab41
Public Version Date
April 20, 2020
Public Version Number
1
DI Record Publish Date
April 12, 2020
Package DI Number
18054242441786
Quantity per Package
10
Contains DI Package
08054242441789
Package Discontinue Date
-
Package Status
In Commercial Distribution
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 |