Heart Sync Sterile Adult Radio Transparent Multi Function Electrodes - The Heart Sync Sterile Adult Radio Transparent - HEART SYNC INC

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 Physio Control quik combo® adapted models of monophasic and bi-phasicdefibrillators.

Want to know more about this Product? Request more information now!


More Product Details

Catalog Number

Sterile-C100-Physio

Brand Name

Heart Sync Sterile Adult Radio Transparent Multi Function Electrodes

Version/Model Number

Sterile-C100-Physio

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

September 30, 2016

Issuing Agency

In GS1

Product Characteristics

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 Details

Product Code

MKJ

Product Code Name

Automated External Defibrillators (Non-Wearable)

Device Record Status

Public Device Record Key

91ccb739-272d-4e37-9891-2d2c6eb48b9c

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

September 16, 2014

Additional Identifiers

Package DI Number

10868866000018

Quantity per Package

10

Contains DI Package

00868866000011

Package Discontinue Date

September 30, 2016

Package Status

Not in Commercial Distribution

Package Type

Box

"HEART SYNC INC" Characteristics
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