Volumetric Infusion Pump System - India CDSCO Medical Device Registration

Volumetric Infusion Pump System is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/MD/2020/000532_56c92bb635e91ca6636e7b069e8d147d_f52aed306b66ea43205b3940bbea997f. This device is marketed under the brand name Perfusor Space. 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 C. The approving authority is CDSCO.

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CDSCO Registered

Class Class C

Volumetric Infusion Pump System

UID: IMP/MD/2020/000532_56c92bb635e91ca6636e7b069e8d147d_f52aed306b66ea43205b3940bbea997f

Brand Name

Perfusor Space

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 C

Approving Authority

CDSCO

Product Information

The Infusomat® Space P Volumetric Infusion Pump System includes an external transportable electronic volumetric infusion pump, administration sets, and pump accessories. The system is intended for use on adults, pediatrics, and neonates for the intermittent or continuous delivery of parenteral and enteral fluids through clinically accepted routes of administration. These routes include, but are not limited to intravenous, irrigation/ ablation, and enteral. The system is used for the delivery of medications indicated for infusion therapy including but not limited to colloids and cristalloids, blood and blood components, Total Parenteral Nutrition (Perfusor Space), lipids, and enteral fluids

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