Customized Kits - 2(Merit Customs Kit - 2 - India CDSCO Medical Device Registration
Customized Kits - 2(Merit Customs Kit - 2 is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/MD/2019/000114_ddc0d120566b62ee4257f4ef22cd0daa_163f3d53882fc35fd6179d813ed7fc98. 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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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.,Device Class
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. Scalpel - A manual surgical instrument for general use, hand-held, disposable, intended to be used in various general surgical procedures
Customized Kits - 1(Merit Customs Kit - 1 )
Brand: includes four devices - i. Hemostasis Valves and accessories ii. Manifolds iii. Stopcocks, iv. Inflation Devices
M/s Merit Medical Systems India Pvt. Ltd.,
Inflation Devices and Kits(Basix Touch, Basix Compak )
Brand: includes four devices - i. Hemostasis Valves and accessories ii. Manifolds iii. Stopcocks, iv. Inflation Devices
M/s Merit Medical Systems India Pvt. Ltd.,
Customized Kits - 3(Merit Customs Kit - 3 )
Brand: includes four devices - i. Hemostasis Valves and accessories ii. Manifolds iii. Stopcocks, iv. Inflation Devices
M/s Merit Medical Systems India Pvt. Ltd.,
Sheath Introducer
Brand: includes four devices - i. Hemostasis Valves and accessories ii. Manifolds iii. Stopcocks, iv. Inflation Devices
M/s Merit Medical Systems India Pvt. Ltd.,
Microcatheter
Brand: includes four devices - i. Hemostasis Valves and accessories ii. Manifolds iii. Stopcocks, iv. Inflation Devices
M/s Merit Medical Systems India Pvt. Ltd.,
Manifolds
Brand: Angiographic Tray
Customized Kits - 1(Merit Customs Kit - 1 )
Brand: includes four devices - i. Hemostasis Valves and accessories ii. Manifolds iii. Stopcocks, iv. Inflation Devices
Aspiration Catheters
Brand: ASAP Aspiration Catheter Kit and ASAPLP Low Profile Aspiration Catheter Kit
Needles
Brand: Angiographic Tray
Inflation Devices and Kits(Basix Touch, Basix Compak )
Brand: includes four devices - i. Hemostasis Valves and accessories ii. Manifolds iii. Stopcocks, iv. Inflation Devices
Customized Kits - 3(Merit Customs Kit - 3 )
Brand: includes four devices - i. Hemostasis Valves and accessories ii. Manifolds iii. Stopcocks, iv. Inflation Devices
Custom Manifold Kit
Brand: Angiographic Tray
Sheath Introducer
Brand: includes four devices - i. Hemostasis Valves and accessories ii. Manifolds iii. Stopcocks, iv. Inflation Devices
Microcatheter
Brand: includes four devices - i. Hemostasis Valves and accessories ii. Manifolds iii. Stopcocks, iv. Inflation Devices
Reshapable Guidewire
Brand: ASAP Aspiration Catheter Kit and ASAPLP Low Profile Aspiration Catheter Kit