i-STAT System

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
    SATP

14 dispositifs médicaux avec un nom similaire

En savoir plus sur les données ici

  • Modèle / numéro de série
    Martel Printer 06F23-91 or 111300 | Martel Printers with serial numbers between
    20091081 and 241248976 that do not have a battery
    door for access to the rechargeable battery pack
  • Description du dispositif
    IVD: Clinical chemistry analyser
  • Manufacturer
  • Modèle / numéro de série
    Model Catalog: 06F01-01 (Lot serial: P08274A); Model Catalog: 06F01-02 (Lot serial: P08274A)
  • Description du dispositif
    I-STAT EG7+ CARTRIDGES
  • Manufacturer
  • Modèle / numéro de série
    Model Catalog: 07G01-01 (Lot serial: ALL LOTS); Model Catalog: 07G01-02 (Lot serial: ALL LOTS); Model Catalog: 07G81-02 (Lot serial: ALL LOTS); Model Catalog: 07G81-01 (Lot serial: ALL LOTS)
  • Description du dispositif
    I-STAT ACT CELITE CARTRIDGE
  • Manufacturer
  • Modèle / numéro de série
    Model Catalog: 06F01-01 (Lot serial: U06024B)
  • Description du dispositif
    i-STAT EG7+ Cartridge
  • Manufacturer
  • Modèle / numéro de série
    Model Catalog: 06F10-02 (Lot serial: K00315 K00315A K00316); Model Catalog: 320100 (Lot serial: K00315 K00315A K00316); Model Catalog: 320100 (Lot serial: T00313 T00313A K00311); Model Catalog: 06F10-02 (Lot serial: T00313 T00313A K00311); Model Catalog: 06F10-01 (Lot serial: T00313 T00313A K00311); Model Catalog: 320100 (Lot serial: P00290 P00293 P00326); Model Catalog: 06F10-02 (Lot serial: P00290 P00293 P00326); Model Catalog: 06F10-01 (Lot serial: P00290 P00293 P00326); Model Catalog: 320100 (Lot serial: K00322B.); Model Catalog: 06F10-02 (Lot serial: K00322B.); Model Catalog: 06F10-01 (Lot serial: K00322B.); Model Catalog: 320100 (Lot serial: K00316A K00320 K00320A); Model Catalog: 06F10-02 (Lot serial: K00316A K00320 K00320A); Model Catalog: 06F10-01 (Lot serial: K00316A K00320 K00320A); Model Catalog: 06F10-01 (Lot serial: K00315 K00315A K00316)
  • Description du dispositif
    I-STAT SYSTEM-CREA CARTRIDGE
  • Manufacturer
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