Datex - Ohmeda, Inc

3 devices in the database

  • Model / Serial
    The lot number is always a six-digit number, where the first digits indicate the manufacturing sub-batch during the month and the last three digits indicate the month and year of the manufacture (MMY). The last three digits indicating month and year of manufacture are most significant. For example, a lot number ending in 086 indicates that this lot was manufactured in August 2006.  -All lots manufactured in July, 2006 (076) or earlier are affected.  -Compact Absorbers from lot numbers 133086 and 136086, manufactured in August, 2006, should be isolated and destroyed. All other lots manufactured in August 2006 (086) are acceptable for use.  -All lots manufactured in September 2006 (096) or later are acceptable for use.
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide, including USA, Austria, Australia, Belgium, Canada, Croatia, Germany, Denmark, Finland, France, Greece, Iceland, Ireland, Italy, Japan, South Korea, Kuwait, Netherlands, Norway, Poland, Portugal, Singapore, South Africa, Spain, Sweden, Switzerland, Turkey, United Arab Emirates, and United Kingdom.
  • Product Description
    Datex Ohmeda Compact Absorber, Disposable, REF 427002100, white to violet and REF 427002000, Pink to white. Used with GE Healthcare ADU anesthesia systems. GE Healthcare Finland Oy, Helsinki, Finland +358 10 39411.
  • Model / Serial
    serial numbers: AETK25021 thru AETK25023, AETK25024, AETK25025, AETK25027 thru AETK25030, AETK27001, AETK27002, AETK27004, AETK27006, AETK27007, AETK27010 thru AETK27015, AETK27017, AETK27019, AETK27020, AETK27024, AETK27025, AETK27027, AETK27031 thru AETK27034, AETK27039, AETK27040, AETK28001 thru AETK28003, AETK28005, AETK28006, AETK28008, AETK28010, AETK28011, AETK28013 thru AETK28017, AETK28019, AETK28021, AETK28023 thru AETK28025, AETK28029, AETK28031thru AETK28038, AETK28040 thru AETK28046, AETK28048, AETK28050 thru AETK28052, AETK28056, AETK28057, AETK28059, AETK28063, AETK28065, AETK28067, AETK28070 thru AETK28072, AETK28074 thru AETK28076, AETK29004, AETK29006, AETK29035, AETK29037, AETK29039, AETK29043, AETK29045, AETK29061, AETK29068, AETK29073, AEWK30001.
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide and Canada.
  • Product Description
    Datex-Ohmeda Tec 6 Plus Desflurane Vaporizer. It is an electronic vaporizer which delivers the anesthetic agent desflurane.
  • Model / Serial
    Serial numbers: CBCH00101, CBCH00110, CBCJ00135, CBCJ00136, CBCJ00207, CBCJ00472, CBCJ00623, CBCJ00685, CBCJ00686, CBCJ00688 thruCBCJ00702, CBCK00100, CBCK00101 thru CBCK00208, CBCK00210 thru CBCK00269, CBCK00271 thru CBCK00298, CBCK00301 thru CBCK00516, CBCK00519 thru CBCK00526, CBCK00535
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    GA, RI, WI, TX. Foreign - AUSTRALIA, BRUNEI DARUSSALAM, BRAZIL, COLOMBIA, COSTA RICA, SPAIN, FINLAND, FRANCE, UNITED KINGDOM, INDIA, ITALY, KOREA, MEXICO, MALAYSIA, PHILIPPINES, SAUDI ARABIA, SWEDEN, SINGAPORE, GERMANY.
  • Product Description
    GE Healthcare Engstrom Carestation Critical Care Ventilator with the High Performance Display Unit with SW version 3.x and 4.11; identification numbers 1505-9000-000 and M1057699 (upgrade). Datex-Ohmeda, Inc., a General Electric Company, doing business as GE Healthcare, P.O. Box 7750, Madison, WI 53707-7550, USA, www.gehealthcare.com.

2 manufacturers with a similar name

Learn more about the data here

  • Manufacturer Address
    Datex - Ohmeda, Inc, Po Box 7550, Madison WI 53707
  • Source
    USFDA