CDSCO UID IMP/MD/2023/001147_9bbf373797bf7cf7ba62c80023682e25_e5612aeb7728ba89926d7bf30125e3afController
- UID
- IMP/MD/2023/001147_9bbf373797bf7cf7ba62c80023682e25_e5612aeb7728ba89926d7bf30125e3af
- Device class
- Class D
- Brand name
- HeartWare™ Controller
- License holder
- India Medtronic Private Limited
- Approving authority
- CDSCO
- Product information
- The controller is a microprocessor unit that controls and manages HVAD® System operation. It sends power and operating signals to the blood pump and collects information from the pump. The percutaneous driveline is connected to the controller, which must always be connected to two power sources - an AC adapter or DC adapter and/or rechargeable batteries. The controller’s internal, non-replaceable, rechargeable battery is used to power an audible [No Power] alarm when both power sources are disconnected. The controller interfaces with the monitor through a data port.
Controller is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/MD/2023/001147_9bbf373797bf7cf7ba62c80023682e25_e5612aeb7728ba89926d7bf30125e3af. This device is marketed under the brand name HeartWare™ Controller. The license holder is India Medtronic Private Limited, and it is classified as Device Class Class D. The approving authority is CDSCO.
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