Heart Sync, Inc

6 dispositifs dans la base de données

  • Modèle / numéro de série
    Lot Number: Y111208-6.
  • Classification du dispositif
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Nationwide Distribution
  • Description du dispositif
    Heart Sync Adult Radiolucent Electrode -Physio Control, Part T100LO-PHYSIO. || Indicated for use in external pacing, defibrillation and monitoring applications as a non-sterile, disposable device for single patient use only.
  • Modèle / numéro de série
    Lot Numbers: Y091008-13, Y091008-14, Y111208-13, and Y111208-14.
  • Classification du dispositif
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Nationwide Distribution
  • Description du dispositif
    Medstorm Adult Radiolucent Leads-Out Electrode - Physio-Control, Part 16242. || Indicated for use in external pacing, defibrillation and monitoring applications as a non-sterile, disposable device for single patient use only.
  • Modèle / numéro de série
    Lot # Y032709-1
  • Classification du dispositif
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution - USA including AK, AZ, CA, FL, IL, KS, LA, MA, ND, NM, OH, TX, WA, WI and WV; and Canada
  • Description du dispositif
    Medstorm Adult Radiolucent Zoll Medical (Part # 16381, HeartSync, Ann Arbor, MI. || The Adult Radiolucent Multifunction Tin 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 cardiac pacemaker and the patients skin. When a patient requires defibrillation, cardioversion or external pacing, these electrodes will be applied to the patient and connected to the respective low power mono-phasic or bi-phasic defibrillator (360 joules maximum) or external pacemaker.
  • Modèle / numéro de série
    Lot Y-032709
  • Classification du dispositif
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution - USA including AK, AZ, CA, FL, IL, KS, LA, MA, ND, NM, OH, TX, WA, WI and WV; and Canada
  • Description du dispositif
    Medstorm Adult Radiolucent Electrode  Philips Medical , Part #16250, HeartSync Ann Arbor, MI. || The Adult Radiolucent Multifunction Tin 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 cardiac pacemaker and the patients skin. When a patient requires defibrillation, cardioversion or external pacing, these electrodes will be applied to the patient and connected to the respective low power mono-phasic or bi-phasic defibrillator (360 joules maximum) or external pacemaker.
  • Modèle / numéro de série
    Part Number: D304 and lot numbers:Y100112-02, Y102212-03, Y121312-18, Y012413-02, Y022013-01, Y032113-01
  • Classification du dispositif
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution - USA including AL, GA, MI, MN, NC, ND, OH, PA, SD, VA, VT, OH, TX, MA, and Internationally to Korea.
  • Description du dispositif
    Vermed, Inc Radiotransparent Defibrillation Electrodes || Monophasic or biphasic compatible defibrillation/cardioversion/pacing/ECG Monitoring electrodes. || Used in connection with a defibrillator to deliver an electrical current (shock) to the patient's heart during cardiac emergencies.
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  • Adresse du fabricant
    Heart Sync, Inc., 5643 Plymouth Rd, Ann Arbor MI 48105-9586
  • Société-mère du fabricant (2017)
  • Source
    USFDA