Duns Number:671405566
Device Description: Disposable multifunctionelectrodes for defibrillation, synchronized cardioversion, transcu Disposable multifunctionelectrodes for defibrillation, synchronized cardioversion, transcutaneous cardiac stimulation and ECG monitoring, with direct connection to cables and defibrillators
Catalog Number
4011052C
Brand Name
VERMED
Version/Model Number
F7952W/1
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
May 18, 2022
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
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
Product Code
LDD
Product Code Name
Dc-Defibrillator, Low-Energy, (Including Paddles)
Public Device Record Key
23342404-191a-493d-b84c-a1319827361f
Public Version Date
May 19, 2022
Public Version Number
5
DI Record Publish Date
January 24, 2018
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. | 50 |