Devices

iSTAT G3 Cartridge

  • Modelo / Serial
    Catalog number: 06F03-1, 06F03-02; Lot numbers: J06072, Exp 10/28/2006; J06076, Exp 11/14/2006; J06081, Exp 11/14/2006; J06083, Exp 11/14/2006; J06085, Exp 11/14/2006.
  • Clasificación del producto
    Clinical Chemistry and Clinical Toxicology Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide distribution: USA and country of : Canada.
  • Descripción del producto
    i-STAT G3+ Cartridge: PCO2 || Abbott Point of Care, || Princeton, NJ 08540 || The test for PCO2, as part of the i-STAT System, is intended for use in the in vitro quantification of carbon dioxide partial pressure in arterial, venous or capillary whole blood. PCO2 along with pH is used to assess acid-base balance.
  • Manufacturer
    Abbott Point Of Care Inc.
  • 1 Event

Fabricante

Abbott Point Of Care Inc.
  • Dirección del fabricante
    Abbott Point Of Care Inc., 400 College Rd E, Princeton NJ 08540-6607
  • Empresa matriz del fabricante (2017)
    Abbott Laboratories
  • Comentario del fabricante
    “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

2 dispositivos con un nombre similar

Más información acerca de la data acá

Device Recall iSTAT G3 Cartridge
  • Modelo / Serial
    List number 03P78-25 :Lot number N13183
  • Clasificación del producto
    Clinical Chemistry and Clinical Toxicology Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution - USA (nationwide) and Internationally to Canada.
  • Descripción del producto
    i-STAT G3+ Cartridge || pH, pCO2 and pO2 measurements are used in the diagnosis, monitoring and treatment of respiratory disturbances and metabolic and respiratory based acid-based disturbances.
  • Manufacturer
    Abbott Point Of Care Inc.
Device Recall iSTAT G3 Cartridge
  • Modelo / Serial
    Lot P08321C, Abbott List number 06F03-01 (USA and Canada), Abbott List Number (rest of world) 06F03-02; Box numbers 1491 and 1534.
  • Clasificación del producto
    Clinical Chemistry and Clinical Toxicology Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution -- USA, Austria, China, India, Saudi Arabia, South Africa, and Taiwan.
  • Descripción del producto
    i-STAT G3+ Cartridge; || pH, PCO, PO. HCO2, TCO2, BE sO2; Test includes: PCO2 for calculated HCO3 and PO2 for calculated oxygen saturated/sO2. Catalog Number 220100. || Abbott Point of Care Inc., || Abbott Park, IL 60064 || The iSTAT G3+ Cartridge is intended to be used to quantitatively measure oxygen, carbon dioxide, and pH.
  • Manufacturer
    Abbott Point of Care Inc.