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CDSCO UID IMP/MD/2019/000524_815278087b7e643a6ef01be64af4f521_ced1b842e17d1816d3a5dbe4f28635a2

Sodium Bicarbonate Cartridge for Haemodialysis

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·India CDSCO·Brand: Sol-Cart B
Registration details
UID
IMP/MD/2019/000524_815278087b7e643a6ef01be64af4f521_ced1b842e17d1816d3a5dbe4f28635a2
Device class
Class B
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
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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About this record

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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