Inflation Devices and Kits(BasixCOMPAK, BIG60 ) - India CDSCO Medical Device Registration

Inflation Devices and Kits(BasixCOMPAK, BIG60 ) is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/MD/2018/000388_14cd98c1ceeb3e05c70e00610f073ce1_5b8aaf0aa918c4c950962f7362552f2a. This device is marketed under the brand name Inflation devices either with Stopcocks / Hemostasis valves or with both. The license holder is M/s Merit Medical Systems 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

Inflation Devices and Kits(BasixCOMPAK, BIG60 )

UID: IMP/MD/2018/000388_14cd98c1ceeb3e05c70e00610f073ce1_5b8aaf0aa918c4c950962f7362552f2a

Brand Name

Inflation devices either with Stopcocks / Hemostasis valves or with both

License Holder

M/s Merit Medical Systems India Private Limited,

Device Class

Class C

Approving Authority

CDSCO

Product Information

Inflation Device - Inflation devices are used to inflate and deflate an angioplasty balloon or other interventional device, and to measure the pressure within the balloon. Stopcocks –are indicated for use in cardiovascular, radiologic, surgical, and therapeutic applications to control or direct fluid flow between tubing, catheters, or other devices. Hemostasis valves - The Merit hemostasis valves are intended for maintaining hemostasis / fluid-tight seal during the introduction, use, and withdrawal of interventional and diagnostic devices during use