Defibrillator
- UID
- MFG/MD/2022/000165_573af448e4733b7079213ab73a413dcb_ec6254a86248050c8a5f65aff6a5b93a
- Device class
- Class C
- Brand name
- Defigard 400
- License holder
- Schiller Healthcare India Pvt. Ltd.
- Approving authority
- Central Drug Standard Control Organisation, South Zone
- Product information
- The Defigard 400 (Defigard 400) is a Defibrillator device, with vital signs monitoring and Transthoracic Pacemaker. The defibrillator is used for the treatment of ventricular fibrillation (Defigard 400) and Ventricular Tachycardia (Defigard 400), in Manual Mode (Defigard 400) or Automated External Defibrillation (Defigard 400) in Semi Automatic Mode (Defigard 400), by applying energy on the chest wall, non-invasively. The Monitoring function allows continuous monitoring of Electrocardiograph (Defigard 400) and optionally to monitor Oxygen Saturation in Peripheral Arteries (Defigard 400), Non Invasive Blood Pressure (Defigard 400) and End Tidal Carbon Dioxide (Defigard 400), from begin to end of an intervention. An optional Transthoracic pacemaker can be used to externally Pace the Heart, to help control abnormal heart rhythms. DG400 is only intended for single patient use, at a time. Device is intended for use on Adult and Child patients with applicable accessory. Device is intended for use in hospital environment and not for home or public use. It shall be used only by trained clinicians or healthcare professionals.
Defibrillator is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID MFG/MD/2022/000165_573af448e4733b7079213ab73a413dcb_ec6254a86248050c8a5f65aff6a5b93a. This device is marketed under the brand name Defigard 400. The license holder is Schiller Healthcare India Pvt. Ltd., and it is classified as Device Class Class C. The approving authority is Central Drug Standard Control Organisation, South Zone.
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