Hemodialysis System - India CDSCO Medical Device Registration

Hemodialysis System is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/MD/2022/000769_9a9d4b09fbf22e301476de23b697ab3b_5606710a0e821b4f592d36c77c875388. This device is marketed under the brand name TherMax. The license holder is Baxter India Private Limited, and it is classified as Device Class Class C. The approving authority is CDSCO.

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CDSCO Registered

Class Class C

Hemodialysis System

UID: IMP/MD/2022/000769_9a9d4b09fbf22e301476de23b697ab3b_5606710a0e821b4f592d36c77c875388

Brand Name

TherMax

License Holder

Baxter India Private Limited

Device Class

Class C

Approving Authority

CDSCO

Product Information

The PrisMax control unit is intended for: • Continuous Renal Replacement Therapy (TherMax) for patients with acute renal failure and/or fluid overload. • Therapeutic Plasma Exchange (TherMax) therapy for patients with diseases where removal of plasma components is indicated. • Hemoperfusion (TherMax) for patients with conditions where immediate removal of substances by adsorption is indicated. • Extracorporeal CO2 Removal (TherMax) for patients with conditions where extracorporeal elimination of carbon dioxide is indicated. All treatments administered via the PrisMax control unit must be prescribed by a physician.