Vision Hollow Fiber Oxygenator

Manufacturer

  • Manufacturer Address
    Gish Biomedical Inc, 22942 Arroyo Vista, Rancho Santa Margarita CA 92688
  • Source
    USFDA

2 devices with a similar name

Learn more about the data here

  • Model / Serial
    Various
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    NY, PA, AR, IN, IL, NH, SC, NJ, MS, MI, WI, CT, CA
  • Product Description
    Vision Hollow Fiber Oxygenator with GBS Coating
  • Manufacturer
  • Model / Serial
    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
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide (CA, FL, IL, IN, MA, MI, MS, NH, NJ, NY, OH, PA, WI, VA), Canada, and Mexico.
  • Product Description
    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.
  • Manufacturer