Duns Number:041356039
Device Description: The Heart Sync Pediatric(infant) Radiotranslucent Multifunction Electrodes are indicated f The Heart Sync Pediatric(infant) Radiotranslucent Multifunction Electrodes are indicated for use in external pacing, defibrillation and monitoring applications as a non-sterile, 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 pediatric patients whose weight is less than 10 kg (100 joules). 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 with Physio-Control connector models of monophasic and bi-phasic defibrillators.
Catalog Number
PEDIATRIC-PHYSIO
Brand Name
Pediatric (infant), radiolucent, defib electrodes w/ Physio connector
Version/Model Number
PEDIATRIC-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
LDD
Product Code Name
Dc-Defibrillator, Low-Energy, (Including Paddles)
Public Device Record Key
612e20ae-d528-49a8-b103-f7dd1d028acf
Public Version Date
March 29, 2018
Public Version Number
2
DI Record Publish Date
August 31, 2016
Package DI Number
10854664006031
Quantity per Package
10
Contains DI Package
00854664006034
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 |