Martel Printer

  • Modèle / numéro de série
  • Description du dispositif
    in-vitro_medical_device
  • Manufacturer
  • 1 Event

Fabricant

  • Société-mère du fabricant (2017)
  • Commentaire du fabricant
    “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
    LAANSM

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  • Modèle / numéro de série
  • Description du dispositif
    in-vitro_medical_device
  • Manufacturer
  • Modèle / numéro de série
  • Description du dispositif
    In-vitro diagnostics
  • Manufacturer
  • Modèle / numéro de série
  • Description du dispositif
    In-vitro diagnostics
  • Manufacturer
  • Modèle / numéro de série
    Printer i-STAT Catalog number 06723-91; battery pack catalog number 06F21-35. Martel Printers with serial numbers 281071578 to 281071977; 281174571 to 281174970; 281276302 to 281276701 and 290178290 to 290178689. Repaired printers received since November 4, 2008; Replacement chargeable battery packs received since October 30, 2008.
  • Classification du dispositif
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution
  • Description du dispositif
    Martel Printer Accessory to i-STAT Portable Clinical Analyzer, rechargeable battery pack. || Printing results of clinical chemistry tests and test panels contained in the i-STAT test cartridges.
  • Manufacturer
  • Modèle / numéro de série
    List number 06F23-91/111300; Abbott list number: 06F23-91 Serial numbers between 20091081 and 241248976.
  • Classification du dispositif
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide distribution
  • Description du dispositif
    Martel Printer || The Martel Printer is an accessory to the i-STAT Portable clinical Analyzer (model 300). The i-STAT Analyzer is used by trained medical professionals for running a variety of clinical chemistry tests and test panels contained in i-STAT test cartridges. These tests include Hematocrit, glucose, blood urea nitrogen, sodium, potassium, chloride, ionized calcium, blood gases (oxygen, carbon dioxide, and pH), Creatinine, lactate and activated clotting time.
  • Manufacturer