Radiometer America Inc

32 devices in the database

  • Model / Serial
    Part # 945-633 - Lot #96-02 and Lot #96-03
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide and Canada.
  • Product Description
    Reference Electrodes for ABL 700/800 Blood Gas Analyzers. Electrode Part Numbers: 945-633, distributed one (1) electrode per box.
  • Model / Serial
    All ABL800 analyzers running software vers 5.21 i.e. ABL8xx 754R00xx N0xx
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide, including USA and Canada.
  • Product Description
    ABL800 Series Blood Gas Analyzer equipped with Software Version 5.21.
  • Model / Serial
    Part #945-603 - Lot #96-01 and #96-02
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide and Canada.
  • Product Description
    Reference Electrodes for ABL 700/800 Blood Gas Analyzers. Electrode Part Number: 945-603, distributed one (1) electrode per box.
  • Model / Serial
    Part #944-025, Lot QR-02, Expiration Date: September 2007.
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    The recalled product was distributed to customers in following states nationwide: AL, AK, AR, AZ, CA, CO, CT, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, MT, NC, ND, NE, NJ, NM, NY, OH, OK, OR, PA, TN, TX, UT, VA, WA, WI, WV and WY
  • Product Description
    S1730 Calibration Solution 2, 200 mL, packed in single unit plastic bottles, REF 944-025, used with ABL700 Series Blood Gas Analyzers.
  • Model / Serial
    ABL800 Flex (902-754)
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution - USA and Canada - Products were sold in all fifty (50) US States. including twenty-nine 29 government accounts and 138 Canadian accounts.
  • Product Description
    ABL800 FLEX Series Analyzer - Human Blood Analyzer (Laboratory Device)
27 more

5 manufacturers with a similar name

Learn more about the data here

  • Manufacturer Address
    Radiometer America Inc, 810 Sharon Dr, Westlake OH 44145-1521
  • Manufacturer Parent Company (2017)
  • Source
    USFDA
  • Manufacturer Address
    Radiometer America Inc, 250 S Kraemer Blvd, Brea CA 92821-6232
  • Manufacturer Parent Company (2017)
  • Source
    USFDA
  • Manufacturer Parent Company (2017)
  • Manufacturers representative
    Salehiya Trading Est.
  • Source
    SFDA
  • Manufacturer Address
    Radiometer America Inc, 810 Sharon Dr, Westlake OH 44145
  • Manufacturer Parent Company (2017)
  • Source
    USFDA