Device Description : MIVI High Flow Tubing is to be used with an external source of vacuum to aspirat MIVI High Flow Tubing is to be used with an external source of vacuum to aspirate, remove, or sample body fluids.
Device Class : 2
Duns Number: 076836823
Premarket Exempt : Yes
Prescription Use : Yes
Device Description : The MIVI Canister Kit contains a vacuum pump canister and other disposable acces The MIVI Canister Kit contains a vacuum pump canister and other disposable accessories to be used with a Gomco 405 Aspiration Pump.
Device Class : 2
Duns Number: 076836823
Premarket Exempt : Yes
Prescription Use : No
Device Description : The Mi-Axus 6F Distal Access Catheter is a single lumen, braided shaft, variable The Mi-Axus 6F Distal Access Catheter is a single lumen, braided shaft, variable stiffness catheter with radiopaque marker on the distal end and a luer hub on the proximal end. The catheter shaft has a hydrophilic coating on the last 60 cm of the distal end.
Device Class : 2
Duns Number: 076836823
Premarket Exempt : No
Prescription Use : Yes
Device Description : The Mi-Axus 6F Distal Access Catheter is a single lumen, braided shaft, variable The Mi-Axus 6F Distal Access Catheter is a single lumen, braided shaft, variable stiffness catheter with radiopaque marker on the distal end and a luer hub on the proximal end. The catheter shaft has a hydrophilic coating on the last 60 cm of the distal end.
Device Class : 2
Duns Number: 076836823
Premarket Exempt : No
Prescription Use : Yes
Device Description : The Mi-Axus 8F Guide Catheter is a single lumen, braided, variable stiffness sha The Mi-Axus 8F Guide Catheter is a single lumen, braided, variable stiffness shaft catheter designed for use in facilitating the insertion and guidance of micro catheters into a selected blood vessel in the peripheral, coronary, or neuro vascular system. A radiopaque marker is included on the distal end. The catheter shaft has a hydrophilic coating. The distal segment of the PEBAX is impregnated with barium sulphate for increased radiopacity.
Device Class : 2
Duns Number: 076836823
Premarket Exempt : No
Prescription Use : Yes
Device Description : The Mi-Axus 8F Guide Catheter is a single lumen, braided, variable stiffness sha The Mi-Axus 8F Guide Catheter is a single lumen, braided, variable stiffness shaft catheter designed for use in facilitating the insertion and guidance of micro catheters into a selected blood vessel in the peripheral, coronary, or neuro vascular system. A radiopaque marker is included on the distal end. The catheter shaft has a hydrophilic coating. The proximal segment is constructed with Vestamid. The distal segment of the PEBAX is impregnated with barium sulphate for increased radiopacity.
Device Class : 2
Duns Number: 076836823
Premarket Exempt : No
Prescription Use : Yes
Device Description : The Mi-Axus 8F Guide Catheter is a single lumen, braided, variable stiffness sha The Mi-Axus 8F Guide Catheter is a single lumen, braided, variable stiffness shaft catheter designed for use in facilitating the insertion and guidance of micro catheters into a selected blood vessel in the peripheral, coronary, or neuro vascular system. A radiopaque marker is included on the distal end. The catheter shaft has a hydrophilic coating. The distal segment of the PEBAX is impregnated with barium sulphate for increased radiopacity.
Device Class : 2
Duns Number: 076836823
Premarket Exempt : No
Prescription Use : Yes
Device Description : The Mi-Axus 8F Guide Catheter is a single lumen, braided, variable stiffness sha The Mi-Axus 8F Guide Catheter is a single lumen, braided, variable stiffness shaft catheter designed for use in facilitating the insertion and guidance of micro catheters into a selected blood vessel in the peripheral, coronary, or neuro vascular system. A radiopaque marker is included on the distal end. The catheter shaft has a hydrophilic coating. The proximal segment is constructed with Vestamid. The distal segment of the PEBAX is impregnated with barium sulphate for increased radiopacity.
Device Class : 2
Duns Number: 076836823
Premarket Exempt : No
Prescription Use : Yes
Device Description : The Mi-Axus 8F Guide Catheter is a single lumen, braided, variable stiffness sha The Mi-Axus 8F Guide Catheter is a single lumen, braided, variable stiffness shaft catheter designed for use in facilitating the insertion and guidance of micro catheters into a selected blood vessel in the peripheral, coronary, or neuro vascular system. A radiopaque marker is included on the distal end. The catheter shaft has a hydrophilic coating. The proximal segment is constructed with Vestamid. The distal segment of the PEBAX is impregnated with barium sulphate for increased radiopacity.
Device Class : 2
Duns Number: 076836823
Premarket Exempt : No
Prescription Use : Yes
Device Description : The MIVI Mi-EXT™ Catheter is a single-lumen, variable stiffness catheter with ra The MIVI Mi-EXT™ Catheter is a single-lumen, variable stiffness catheter with radiopaque markers on the distal and proximal end of the catheter portion of angiographic visualization. The catheter shaft has a hydrophilic coating. The proximal portion of the catheter is a stainless-steel control wire.
Device Class : 2
Duns Number: 076836823
Premarket Exempt : No
Prescription Use : Yes