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Company Name Brand Name GMDN Term Name GMDN Term Status FDA Product Code Name FDA Product Code Device Packaged As Sterile Sterilization Prior To Use Issuing Agency Device Size Device Size Type Device Class Implantable

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LIFEPAK® 500 Automated External Defibrillator - 00681490577557

FINAL ASSY-LP500,ENGLISHVOICE,3 BUTTON OP
PHYSIO-CONTROL, INC.
99401
Not in Commercial Distribution

  • 00681490577557 ()
99401-000153

  • Non-rechargeable public semi-automated external defibrillator

LIFEPAK® 500 Automated External Defibrillator - 00681490577472

FINAL ASSY-LP500,ENGLISH, VOICE
PHYSIO-CONTROL, INC.
99401
Not in Commercial Distribution

  • 00681490577472 ()
99401-000130

  • Non-rechargeable public semi-automated external defibrillator

LIFEPAK® 500 Automated External Defibrillator - 00681490577441

FINAL ASSY - LP500, ENGLISH,NO VOICE
PHYSIO-CONTROL, INC.
99401
Not in Commercial Distribution

  • 00681490577441 ()
99401-000042

  • Non-rechargeable public semi-automated external defibrillator

LIFEPAK® 500 Automated External Defibrillator - 00681490576598

ASSY-FINAL,LP500
PHYSIO-CONTROL, INC.
99401
Not in Commercial Distribution

  • 00681490576598 ()
99401-000001

  • Non-rechargeable public semi-automated external defibrillator

LISO2,FAA,LITHIUM BATTERY - 00681490576345

ASSY-BATTERY,LITHIUM,4CELL,DSIZE,ENG,FAA
PHYSIO-CONTROL, INC.
11141
Not in Commercial Distribution

  • 00681490576345 ()
11141-000014

  • Primary battery

LIFEPAK 500 Rechargeable Battery Pack - 00681490576154

ASSY-BATTERY,SLA,4 CELL,D-SIZE,ENG
PHYSIO-CONTROL, INC.
11141
Not in Commercial Distribution

  • 00681490576154 ()
11141-000002

  • Portable/mobile rechargeable battery pack

Heart Sync Sterile Adult Radio Transparent Multi Function Electrodes - 00868866000035

The Heart Sync Sterile Adult Radio Transparent Multi Function Electrodes are indicated for use in external pacing, defibrillation and monitoring applications as a 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 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 "Anderson" adapted models of monophasic and bi-phasic defibrillators.
HEART SYNC INC
Sterile-C100
Not in Commercial Distribution

  • 10868866000032 ()
  • 00868866000035 ()
Sterile-C100

  • Electrode conductive skin pad, single-use

Heart Sync Sterile Adult Radio Transparent Multi Function Electrodes - 00868866000028

The Heart Sync Sterile Adult Radio Transparent Multi Function Electrodes are indicated for use in external pacing, defibrillation and monitoring applications as a 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 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 Zoll adapted models of monophasic and bi-phasic defibrillators.
HEART SYNC INC
Sterile-C100-Zoll
Not in Commercial Distribution

  • 10868866000025 ()
  • 00868866000028 ()
Sterile-C100-Zoll

  • Electrode conductive skin pad, single-use

Heart Sync Sterile Adult Radio Transparent Multi Function Electrodes - 00868866000011

The Heart Sync Sterile Adult Radio Transparent Multi Function Electrodes are indicated for use in external pacing, defibrillation and monitoring applications as a 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 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 Physio Control quik combo® adapted models of monophasic and bi-phasic defibrillators.
HEART SYNC INC
Sterile-C100-Physio
Not in Commercial Distribution

  • 10868866000018 ()
  • 00868866000011 ()
Sterile-C100-Physio

  • Electrode conductive skin pad, single-use

Heart Sync T-CardiacSci-AED™ Pads - 00868866000004

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 and not breathing spontaneously. Heart Sync T100-CS AED pads are single use and intended to be used in conjunction with Cardiac Science automated external defibrillators (AED) to monitor and deliver defibrillation energy to the patient. The T100-CS AED pads are used on patients over 8 years of age or greater than 55 pounds. The electrodes are intended for short term use (less than 8 hours)
HEART SYNC INC
T100-CS
In Commercial Distribution

  • 00868866000004 ()
  • 10868866000001 ()
T100-CS

  • Electrode conductive skin pad, single-use
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