Sodium Bicarbonate Cartridge for Haemodialysis - India CDSCO Medical Device Registration

Sodium Bicarbonate Cartridge for Haemodialysis is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/MD/2019/000524_815278087b7e643a6ef01be64af4f521_ced1b842e17d1816d3a5dbe4f28635a2. This device is marketed under the brand name Sol-Cart B. The license holder is B BRAUN MEDICAL INDIA PRIVATE LIMITED ,OFFICE NO. A/11, GRD FLR, GUNDECHA ONCLAVE PREMISES CHSL, A WING, CTS NO. 99A & 97A, SAKI VILLAGE, KHERANI RD, SAKINAKA, MUMBAI, Tal - SAKINAKA ( MUMBAI-ZONE4 ) ,Mumbai Suburban Maharashtra ,400072 ,India, and it is classified as Device Class Class B. The approving authority is CDSCO.

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CDSCO Registered

Class Class B

Sodium Bicarbonate Cartridge for Haemodialysis

UID: IMP/MD/2019/000524_815278087b7e643a6ef01be64af4f521_ced1b842e17d1816d3a5dbe4f28635a2

Brand Name

Sol-Cart B

License Holder

B BRAUN MEDICAL INDIA PRIVATE LIMITED ,OFFICE NO. A/11, GRD FLR, GUNDECHA ONCLAVE PREMISES CHSL, A WING, CTS NO. 99A & 97A, SAKI VILLAGE, KHERANI RD, SAKINAKA, MUMBAI, Tal - SAKINAKA ( MUMBAI-ZONE4 ) ,Mumbai Suburban Maharashtra ,400072 ,India

Device Class

Class B

Approving Authority

CDSCO

Product Information

To produce an alkaline bicarbonate hemodialysis concentrate for extracorporeal bicarbonate hemodialysis or bicarbonate hemodiafiltration. The indications below apply exclusively to the ready-to-use hemodialysis solution prepared from alkaline and acidic bicarbonate hemodialysis concentrates diluted as directed: • Acute renal failure • Chronic renal failure • Hyperhydration • Intoxications • Compensation of the acid-base and electrolyte balances • Adjustment of the blood / plasma / body temperature

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Other Products from B BRAUN MEDICAL INDIA PRIVATE LIMITED ,OFFICE NO. A/11, GRD FLR, GUNDECHA ONCLAVE PREMISES CHSL, A WING, CTS NO. 99A & 97A, SAKI VILLAGE, KHERANI RD, SAKINAKA, MUMBAI, Tal - SAKINAKA ( MUMBAI-ZONE4 ) ,Mumbai Suburban Maharashtra ,400072 ,India

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