Duns Number:041356039
Device Description: The Heart Sync Sterile Adult Radio Transparent Multi Function Electrodes are indicated for The Heart Sync Sterile Adult Radio Transparent Multi Function Electrodes are indicated for use inexternal pacing, defibrillation and monitoring applications as a sterile, disposable device for singlepatient use only. The electrodes provide the conductive interface between the defibrillator and/or theexternal transcutaneous (noninvasive) cardiac pacemaker and the patient's skin. The electrode isintended for use on adult patients (>22lbs/10kg). When a patient requires defibrillation, cardioversion or externalpacing, these electrodes will be applied to the patient and connected to the instrument. This device isintended for use on defibrillators whose output is classified as low power (360 joule maximum).Compatible with "Anderson" adapted models of monophasic and bi-phasicdefibrillators.
Catalog Number
Sterile-C100
Brand Name
Heart Sync Sterile Adult Radio Transparent Multi Function Electrodes
Version/Model Number
Sterile-C100
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
September 30, 2016
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
MKJ
Product Code Name
Automated External Defibrillators (Non-Wearable)
Public Device Record Key
39576116-aa4e-4d00-a6bc-57bcffce52c3
Public Version Date
March 29, 2018
Public Version Number
2
DI Record Publish Date
September 16, 2014
Package DI Number
10868866000032
Quantity per Package
10
Contains DI Package
00868866000035
Package Discontinue Date
September 30, 2016
Package Status
Not in Commercial Distribution
Package Type
Box
| 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 |