Gish Biomedical Inc

315402, 307412, 336406, 010506, 067511, 080507, 171510, 220523, 336410, 005504, 031514, 087515, 143509, 157511, 199513, 234518, 262511, 0535818, 180501, 348420, 053515, 249512, 125515, 157527, 178525, 130500, 241500, 133500, 320408, 234515, 285417, 313418, 334408, 024507, 053510, 117501, 122508, 151509, 210510, 220526, 224519, 328415, 053511, 067515, 157509, 178520, 199510, 266509, 067518, 101520, 220530, 270503, 348400

Cardiovascular Devices

2

No

CA, FL, IN, MA, MI, NJ, NY

The GISH Vision Blood Cardioplegia System with GBS coating (a non-leaching heparin coating) (product desgination VBCXGBS) consists of an extracorporeal heat exhanger and fluid administration set. The heat exchanger consists of a one piece, stainless steel bellows-configured heat exchanger as the primary element to effect heat exchange. This element is encased by a polycarbonate housing, which directs the blood through the convolutions, and therefore improves heat exchange, minimizes priming volume, and reduces shunting. All materials of the heat exchanger are biocompatible. The device allows for the monitoring of pressure and allows for trapping and removal of air. Additionally, the device includes an integral bubble trap, gross filter and pressure relief device designed to open in the event of excessive fluid pressure during use. Solutions are delivered to the patient through a roller pump through the table line extension and appropriate cannula.

313417, 324404, 241506, 192513, 206510, 241506, 255514, 283507, 40501, 88508, 199547, 208500, 213508, 213508A, 231517, 290542, 007515, 328426, 074507, 122554, 174519, 262552, 323419, 007515, 338420, 035504, 047500, 047501, 047502, 067549, 088507, 122555, 151543, 151542, 215501, 231519, 129535, 250502, 255515, 323419, 336410, 005504, 031514, 087515, 143509, 157511, 199513, 234518, 262511, 313451, 334412, 334412A, 038500, 045550, 053513, 102500, 129525, 160500, 193500, 216501, 252500, 276506, 283512, 241509, 255514, 122554, 047502, 328426, 074507, 125515, 157527, 290519, 199512, 133500, 130500, 241500, 314410, 328426, 213508, 313420, 024509, 004507, 067516, 348414, 101518, 047502, 314409, 323419, 007515, 045557, 059500, 109507, 154510, 046502, 143507, 067518, 101520, 038522, 348418, 038522, 080511, 129527, 206515

Cardiovascular Devices

2

No

Nationwide (CA, FL, IL, IN, MA, MI, MS, NH, NJ, NY, OH, PA, WI, VA), Canada, and Mexico.

The GISH Vision Hollow Fiber Oxygenator with GBS coating (a non-leaching heparin coating) is a sterile, non-pyrogenic, single use, disposable, extracorporeal device designed to be used in an extracorporeal blood circuit to control exchange of gases. It is intended for the supply of oxygen to, and the removal of carbon dioxide from, the blood of humans. An integral heat exchanger is included which is intended to control the temperature of the blood.

Various

Cardiovascular Devices

2

No

NY, PA, AR, IN, IL, NH, SC, NJ, MS, MI, WI, CT, CA

Vision Hollow Fiber Oxygenator with GBS Coating