Abbott Point of Care Inc.

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Description

9 devices in the database

  • Model / Serial
    Catalog Number: 06F09-01; 06F09-02 Lot Numbers: A07102A; A07124; A07138; D07117; D07119; D07120; and D07121.
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution- including USA and country of Canada.
  • Product Description
    Abbott Point of Care, i-STAT G Cartridge; (Glucose/Glu); List No: 06F09-01; Part No: 120100; Abbott Point of Care, Inc., East Windsor, NJ 08520, USA; Product of Canada.
  • Model / Serial
    Catalog Number: 06F04-01; 06F04-02 Lot Numbers: A07110 and A07153.
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution- including USA and country of Canada.
  • Product Description
    Abbott Point of Care, i-STAT EC8+ Cartridge; (NA K CL Glu pH PCO 2 UN/Urea Hct); List No: 06F04-01; Part No: 12500; Abbott Point of Care Inc., East Windsor, NJ 08520, USA; Product of Canada.
  • Model / Serial
    Catalog Number: 06F10-01; 06F10-02 Lot Numbers: A07149; A07150; G07121; G07148; G07150; G07151; G07151A; G07157; G07158; and G07164A.
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution- including USA and country of Canada.
  • Product Description
    Abbott Point of Care, i-STAT CREA Cartridge (Creatine/Crea); List No: 06F10-01; Part No: 320100; Abbott Point of Care Inc., East Windsor, NJ 08520 USA; Product of Canada.
  • Model / Serial
    Catalog Number: 06F07-01; 06F07-02 Lot Numbers: A07163A; D07116A; and D07144.
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution- including USA and country of Canada.
  • Product Description
    Abbott Point of Care, i-STAT EC4+ Cartridge; (NA K Glu Hct); List No: 06F07-01; Part No: 121500; Abbott Point of Care Inc., East Windsor, NJ 08520 USA; Product of Canada.
  • Model / Serial
    Catalog Number: 06F08-01; 06F08-02 Lot Numbers: A07104; A07140; A07141; and D07114
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution- including USA and country of Canada.
  • Product Description
    Abbott Point of Care, i-STAT E3+ Cartridge, (NA K Hct); List No: 06F08-01; Part No: 120500; Abbott Point of Care Inc., East Windsor, NJ 08520 USA; Product of Canada.
4 more

8 manufacturers with a similar name

Learn more about the data here

  • Manufacturer Address
    Abbott Point Of Care Inc., 400 College Rd E, Princeton NJ 08540-6607
  • Manufacturer Parent Company (2017)
  • Manufacturer comment
    “We are in constant communication with regulatory agencies and competent authorities worldwide which allows us to implement global recalls or in-country communication quickly and effectively,” Abbott, which now owns St. Jude Medical told ICIJ in a statement. In addition to sending global notices to physicians worldwide, we also make sure that product advisories are available online and classification of product recalls and product advisories are determined by global regulatory bodies which can impact the timing in any given country. MD companies follow varying regulations in different countries. In come countries software is not regulated so a recall in one country related to software would not be classified as a recall or field action in another. In addition, review cycles within the regulatory process can be different in each country which can impact communication and recall timing.
  • Source
    USFDA
  • Manufacturer Address
    Abbott Point of Care Inc., 104 Windsor Center Dr, East Windsor NJ 08520-1407
  • Source
    USFDA
  • Manufacturer Address
    Abbott Point of Care Inc., 400 College Rd E, Princeton NJ 08540-6607
  • Manufacturer Parent Company (2017)
  • Manufacturer comment
    “We are in constant communication with regulatory agencies and competent authorities worldwide which allows us to implement global recalls or in-country communication quickly and effectively,” Abbott, which now owns St. Jude Medical told ICIJ in a statement. In addition to sending global notices to physicians worldwide, we also make sure that product advisories are available online and classification of product recalls and product advisories are determined by global regulatory bodies which can impact the timing in any given country. MD companies follow varying regulations in different countries. In come countries software is not regulated so a recall in one country related to software would not be classified as a recall or field action in another. In addition, review cycles within the regulatory process can be different in each country which can impact communication and recall timing.
  • Source
    USFDA
  • Manufacturer Parent Company (2017)
  • Manufacturer comment
    “We are in constant communication with regulatory agencies and competent authorities worldwide which allows us to implement global recalls or in-country communication quickly and effectively,” Abbott, which now owns St. Jude Medical told ICIJ in a statement. In addition to sending global notices to physicians worldwide, we also make sure that product advisories are available online and classification of product recalls and product advisories are determined by global regulatory bodies which can impact the timing in any given country. MD companies follow varying regulations in different countries. In come countries software is not regulated so a recall in one country related to software would not be classified as a recall or field action in another. In addition, review cycles within the regulatory process can be different in each country which can impact communication and recall timing.
  • Source
    VNSAWH
  • Manufacturer Parent Company (2017)
  • Manufacturer comment
    “We are in constant communication with regulatory agencies and competent authorities worldwide which allows us to implement global recalls or in-country communication quickly and effectively,” Abbott, which now owns St. Jude Medical told ICIJ in a statement. In addition to sending global notices to physicians worldwide, we also make sure that product advisories are available online and classification of product recalls and product advisories are determined by global regulatory bodies which can impact the timing in any given country. MD companies follow varying regulations in different countries. In come countries software is not regulated so a recall in one country related to software would not be classified as a recall or field action in another. In addition, review cycles within the regulatory process can be different in each country which can impact communication and recall timing.
  • Source
    SATP
3 more