HEART SYNC INC

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Device Description : Can be used in place of Cardiac Science™ electrodes part # 9131-001.Indicated fo Can be used in place of Cardiac Science™ electrodes part # 9131-001.Indicated for use to treat patients in cardiopulmonary arrest who are unconscious, without a pulse andnot breathing spontaneously. Heart Sync T100-CS AED pads are single use and intended tobe used in conjunction with Cardiac Science automated external defibrillators (AED) to monitor anddeliver defibrillation energy to the patient. The T100-CS AED pads are used on patients over8 years of age or greater than 55 pounds. The electrodes are intended for short term use (less than 8hours)

Device Class :

Duns Number: 041356039

Premarket Exempt : Yes

Product Code : MKJ

Prescription Use : Yes

Device Count : 1

Device Description : The Heart Sync Sterile Adult Radio Transparent Multi Function Electrodes are ind 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.

Device Class : 3

Duns Number: 041356039

Premarket Exempt : Yes

Product Code : MKJ

Prescription Use : Yes

Device Count : 1

Device Description : The Heart Sync Sterile Adult Radio Transparent Multi Function Electrodes are ind 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 Zoll adapted models of monophasic and bi-phasicdefibrillators.

Device Class : 3

Duns Number: 041356039

Premarket Exempt : Yes

Product Code : MKJ

Prescription Use : Yes

Device Count : 1

Device Description : The Heart Sync Sterile Adult Radio Transparent Multi Function Electrodes are ind 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.

Device Class : 3

Duns Number: 041356039

Premarket Exempt : Yes

Product Code : MKJ

Prescription Use : Yes

Device Count : 1

Device Description : The Heart Sync Adult/Child Radio Transparent Multi Function Electrodes are indic The Heart Sync Adult/Child Radio Transparent Multi Function Electrodes are indicated for use inexternal pacing, defibrillation and monitoring applications,as a 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 Connector adapted models of monophasic and bi-phasicdefibrillators.

Device Class :

Duns Number: 041356039

Premarket Exempt : Yes

Product Code : MLN

Prescription Use : Yes

Device Count : 1

Device Description : The Heart Sync Adult/Child Radio Transparent Multi Function Electrodes are indic The Heart Sync Adult/Child Radio Transparent Multi Function Electrodes are indicated for use inexternal pacing, defibrillation and monitoring applications as a 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 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). Compatible with Philips Plug style connector models of monophasic and bi-phasic defibrillators.

Device Class :

Duns Number: 041356039

Premarket Exempt : Yes

Product Code : MLN

Prescription Use : Yes

Device Count : 1

Device Description : The Heart Sync Adult/Child Radio Transparent Multi Function Electrodes are indic The Heart Sync Adult/Child Radio Transparent Multi Function Electrodes are indicated for use inexternal pacing, defibrillation and monitoring applications,as a 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/child 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.

Device Class : 2

Duns Number: 041356039

Premarket Exempt : Yes

Product Code : MLN

Prescription Use : Yes

Device Count : 1

Device Description : The Heart Sync Adult/Child Radio Transparent Multi Function Electrodes are indic The Heart Sync Adult/Child Radio Transparent Multi Function Electrodes are indicated for use inexternal pacing, defibrillation and monitoring applications as a 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/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).Compatible with Zoll adapted models of monophasic and bi-phasic defibrillators.

Device Class : 2

Duns Number: 041356039

Premarket Exempt : Yes

Product Code : MLN

Prescription Use : Yes

Device Count : 1

Device Description : The Heart Sync Adult/Child Radio Transparent Multi Function Electrodes are indic The Heart Sync Adult/Child Radio Transparent Multi Function Electrodes are indicated for use inexternal pacing, defibrillation and monitoring applications, 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/child 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.

Device Class : 2

Duns Number: 041356039

Premarket Exempt : Yes

Product Code : MLN

Prescription Use : Yes

Device Count : 1

Device Description : The Heart Sync Adult/Child Radio Transparent Multi Function Electrodes are indic The Heart Sync Adult/Child Radio Transparent 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). Compatible with Philips Plug Style connector models of monophasic and bi-phasic defibrillators.

Device Class : 2

Duns Number: 041356039

Premarket Exempt : Yes

Product Code : MLN

Prescription Use : Yes

Device Count : 1