Sheath Introducer - India CDSCO Medical Device Registration
Sheath Introducer is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/MD/2019/000114_3415b9de3c14ba4ae4c2fa58f5924b7b_117e432ca3e57ac361b278bf61293f3b. 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
Merit Prelude Sheath Introducer is intended to provide access and facilitate the percutaneous introduction of various devices into veins and/or arteries while maintaining hemostasis for a variety of diagnostic and therapeutic procedures. The Merit Prelude Short Sheath Introducer is intended to provide access and facilitate the percutaneous introduction of various devices into veins and/or arteries while maintaining hemostasis for a variety of diagnostic and therapeutic procedures. This device can also provide access to a native or synthetic graft used for hemodialysis. The side port of the sheath allows adequate flow to perform temporary hemodialysis. This device is not indicated for long term vascular or hemodialysis access. The Merit Prelude EASE Hydrophilic Sheath Introducer is intended to provide access and facilitate the percutaneous introduction of various devices into veins and/or arteries, including but not limited to the radial artery, while maintaining hemostasis for a variety of diagnostic and therapeutic procedures. The access needle with inner metal needle and outer plastic cannula is used to gain access to the vein or artery for placement of guide wires. The Merit Prelude Ideal Hydrophilic Sheath Introducer is intended to provide access and facilitate the percutaneous introduction of various devices into veins and/or arteries, including but not limited to the radial artery, while maintaining hemostasis for a variety of diagnostic and therapeutic procedures. The access needle with inner metal needle and outer plastic cannula is used to gain access to the vein or artery for placement of guide wires
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.,
Customized Kits - 2(Merit Customs Kit - 2
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.,
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
Customized Kits - 2(Merit Customs Kit - 2
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
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