Defibrillator - India CDSCO Medical Device Registration
Defibrillator is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/MD/2021/000585_573af448e4733b7079213ab73a413dcb_14cf14e2c7543ac3547d94e160383f2a. This device is marketed under the brand name LIFEPAK 20e Monitor/Defibrillator and accessories. The license holder is M/s Stryker India Private Ltd.,, and it is classified as Device Class Class C. The approving authority is CDSCO.
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Brand Name
LIFEPAK 20e Monitor/Defibrillator and accessories
License Holder
M/s Stryker India Private Ltd.,Device Class
Approving Authority
CDSCO
Product Information
The LIFEPAK CR Plus and LIFEPAK EXPRESS defibrillators are indicated for use on patients in cardiac arrest. The patient must be unresponsive (LIFEPAK 20e Monitor/Defibrillator and accessories), not breathing normally, and showing no signs of circulation (LIFEPAK 20e Monitor/Defibrillator and accessories). The LIFEPAK CR Plus and LIFEPAK EXPRESS defibrillators are intended for use by personnel who have been trained in their operation. Users should have received training in basic life support/AED, advanced life support or a physician-authorized emergency medical response training program. The defibrillators may be used with QUIK-PAKTM defibrillation pads only on adults and children who are 8 years old or more, or who weigh more than 25 kg (LIFEPAK 20e Monitor/Defibrillator and accessories). The defibrillators may be used on children who are less than 8 years old or weigh less than 25 kg (LIFEPAK 20e Monitor/Defibrillator and accessories) with Infant/Child Reduced Energy Defibrillation Electrodes. The defibrillators may be used with the CHARGE-PAKTM battery charger
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