CDSCO UID IMP/MD/2019/000114_f0ccf909245491495232fedcf5fd0ddb_ed326cf5b5b51d964686a5951240c5a9
Customized Kits - 1(Merit Customs Kit - 1 )
M/s Merit Medical Systems India Pvt. Ltd.,·Device Class Class C·India CDSCO·Brand: includes four devices - i. Hemostasis Valves and accessories ii. Manifolds iii. Stopcocks, iv. Inflation Devices
Registration details
- UID
- IMP/MD/2019/000114_f0ccf909245491495232fedcf5fd0ddb_ed326cf5b5b51d964686a5951240c5a9
- Device class
- Class C
- Brand name
- includes four devices - i. Hemostasis Valves and accessories ii. Manifolds iii. Stopcocks, iv. Inflation Devices
- License holder
- M/s Merit Medical Systems India Pvt. Ltd.,
- Approving authority
- CDSCO
- Product information
- The customized Kit configuration consists of bundling individually sterilized, pouched and labeled standalone 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. Manifold - Merit Manifolds are indicated for use in diagnostic and interventional applications to control or direct fluid flow between tubing, catheters, or other devices. Stopcock – are indicated for use in cardiovascular, radiologic, surgical, and therapeutic applications to control or direct fluid flow between tubing, catheters or other devices. Syringes - The Merit Syringe is used to inject fluids into, or withdraw fluids from, the body. The Merit Coronary Control Syringe is intended to be used for the intra-arterial or intravenous administration of radiographic contrast media. The syringe can also be used to inject fluids into, or withdraw fluids from, the body. Needles - The Merit Majestik Series Angiography Needles are disposable non-pyrogenic, single use, for providing a puncture site in vessels for the introduction of vascular access devices. The Merit Advance Angiographic Safety Needle is used for providing a puncture site in blood vessels for the introduction of vascular access devices. It also incorporates a safety mechanism to minimize needlestick injuries. The Merit Advance Series Angiographic Needles are used for providing a puncture site in blood vessels for the introduction of vascular access devices. 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. Tubing - Merit Medical tubing is intended to be used during an angiographic procedure as a conduit to supply a bolus of contrast media which is usually injected mechanically to view heart function under fluoroscopy Scalpel - A manual surgical instrument for general use, hand-held, disposable, intended to be used in various general surgical procedures
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About this record
Customized Kits - 1(Merit Customs Kit - 1 ) is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/MD/2019/000114_f0ccf909245491495232fedcf5fd0ddb_ed326cf5b5b51d964686a5951240c5a9. This device is marketed under the brand name includes four devices - i. Hemostasis Valves and accessories ii. Manifolds iii. Stopcocks, iv. Inflation Devices. The license holder is M/s Merit Medical Systems India Pvt. Ltd.,, and it is classified as Device Class Class C. The approving authority is CDSCO.
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