Defibrillator(ZOLL) - India CDSCO Medical Device Registration

Defibrillator(ZOLL) is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/MD/2023/000158_d4cdf5d37b03dc90281da2975f9144e4_242290937903041a0065207c5d0ddadb. This device is marketed under the brand name Powerheart G5 AED. The license holder is ZOLL Medical India Pvt. Ltd.,, and it is classified as Device Class Class C. The approving authority is CDSCO.

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CDSCO Registered

Class Class C

Defibrillator(ZOLL)

UID: IMP/MD/2023/000158_d4cdf5d37b03dc90281da2975f9144e4_242290937903041a0065207c5d0ddadb

Brand Name

Powerheart G5 AED

License Holder

ZOLL Medical India Pvt. Ltd.,

Device Class

Class C

Approving Authority

CDSCO

Product Information

The Powerheart® G5 is indicated for emergency treatment of victims exhibiting symptoms of sudden cardiac arrest who are unresponsive and not breathing or not breathing normally. Postresuscitation, if the patient is breathing, the AED should be left attached to allow for acquisition and detection of the ECG rhythm. If a shockable ventricular tachyarrhythmia recurs, the device will charge automatically and advise the operator to deliver a shock, or for an automatic AED, automatically deliver a shock if needed. When a patient is a child up to 8 years of age, or up to 25 kg (Powerheart G5 AED), the Powerheart G5 AED should be used with Pediatric Defibrillation Pads. The therapy should not be delayed to determine the patient’s exact age or weight