Radiometer America Inc

32 devices in the database

  • Model / Serial
    All analyzers manufactured from 1/2005-10/31/2005. The devices contain serial numbers 902-441RxxxNxxx. The Rxxx number denotes manufacturing run, and the Nxxx number denotes the individual instrument within the run.
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide.
  • Product Description
    Blood Gas and Co-Ox Electrolyte & Metabolyte Analyzer, ABL-800 series.
  • Model / Serial
    All analyzers manufactured from 1/1999-12/2005. The devices contain serial numbers 902-441RxxxNxxx. The Rxxx number denotes manufacturing run, and the Nxxx number denotes the individual instrument within the run.
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide.
  • Product Description
    Blood Gas and Co-Ox Electrolyte & Metabolyte Analyzer, ABL-700 series.
  • Model / Serial
    Lot Code: R0053.
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide.
  • Product Description
    D 744 Chloride membrane, CI, REF Model #942-061, accessory to the ABL700 blood analyzer.
  • Model / Serial
    Lot R0187, Expiration Date: Sept. 2005; and Lot R0016, Expiration Date: 08/2005.
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    The recalled device component was distributed to a total of 56 customers, nationwide located in the following states: AL, AR, AZ, CA, CO, GA, ID, IL, KA, MA, ME, MI, MO, MS, NC, ND, NE, NH, NJ, NV, NY, OH, OK, PA, SC, SD, TX, UT & WA.
  • Product Description
    D7120, BG-OX Cartridge, D7120 REF 946-003, and 946-001, cuvettes for the NPT7 series of blood gas analyzers.
  • Model / Serial
    Lot Code: R0308, Expiration Date: 4/07; Lot Code: R0309, Expiration Date: 5/07; and Lot Code: R0310, Expiration Date: 5/07.
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide, including TX, OK, MI, CO, NY, and Canada.
  • Product Description
    D711, Reference Membranes, Part #942-058, used with the ABL835 Blood Gas Analyzers.
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