HEART SYNC INC

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Device Description : The Heart Sync Adult/Child Radiotranslucent Multi-Function Electrodes are indic 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.

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). Comparable to Physio-Control 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

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). Comparable with Zoll 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

Device Description : The Heart Sync Pediatric(infant) Radiotranslucent Multifunction Electrodes are i 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.

Device Class :

Duns Number: 041356039

Premarket Exempt : Yes

Product Code : LDD

Prescription Use : Yes

Device Count : 1

Device Description : The Heart Sync Pediatric(infant) Radiotranslucent Multifunction Electrodes are i 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 Anderson connectors adapted cable.

Device Class : 2

Duns Number: 041356039

Premarket Exempt : Yes

Product Code : LDD

Prescription Use : Yes

Device Count : 1

Device Description : The Heart Sync Pediatric(infant) Radiotranslucent Multifunction Electrodes are i 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 Philips Plug Style connector models of monophasic and bi-phasic defibrillators.

Device Class : 2

Duns Number: 041356039

Premarket Exempt : Yes

Product Code : LDD

Prescription Use : Yes

Device Count : 1

Device Description : The Heart Sync Pediatric(infant) Radiotranslucent Multifunction Electrodes are i 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 Zoll connector models of monophasic and bi-phasic defibrillators.

Device Class : 2

Duns Number: 041356039

Premarket Exempt : Yes

Product Code : LDD

Prescription Use : Yes

Device Count : 1

Device Description : The Heart Sync Adult/Child Radiotranslucent Multi-Function Electrodes are indic 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 with Anderson connectors adapted cable.

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 Radiotranslucent Multi-Function Electrodes are indic 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 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

Device Description : The Heart Sync Adult/Child Radiotranslucent Multi-Function Electrodes are indic 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 with Zoll 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