Duns Number:041356039
Device Description: The Heart Sync Adult/Child Radiotranslucent Multi-Function Electrodes are indicated for u The Heart Sync Adult/Child Radiotranslucent Multi-Function Electrodes are indicated for use in external pacing, defibrillation and monitoring applications as a disposable device for single patient use only. The electrodes provide the conductive interface between the defibrillator and/or the external transcutaneous (noninvasive) cardiac pacemaker and the patient's skin. The electrode is intended for use on adult/child patients (>22lbs/10kg). When a patient requires defibrillation, cardioversion or external pacing, these electrodes will be applied to the patient and connected to the instrument. This device is intended for use on defibrillators whose output is classified as low power (360 joule maximum). Comparable Physio-Control connector models of monophasic and bi-phasic defibrillators.
Catalog Number
T100AC-PHYSIO
Brand Name
Adult/Child, radiolucent, defib electrodes w/ Physio connector
Version/Model Number
T100AC-PHYSIO
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
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
-
Product Code
MLN
Product Code Name
Electrode, Electrodcardiograph, Multi-Function
Public Device Record Key
13896c46-ee76-4cba-b07a-5155eb061698
Public Version Date
March 29, 2018
Public Version Number
2
DI Record Publish Date
August 30, 2016
Package DI Number
10854664006000
Quantity per Package
10
Contains DI Package
00854664006003
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. | 23 |
| 3 | A medical device with high risk that requires premarket approval | 3 |