FreeStyle blood glucose test strips


  • 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.
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  • Modèle / numéro de série
    Part number 12050-21: Lot number: 1285007 Exp. date: 2014/06; Part number 70792-20 (instuitional use) Lot number: 1373262, Exp. Date 2015/02
  • Classification du dispositif
  • Classe de dispositif
  • Dispositif implanté ?
  • Distribution
    Worldwide Distribution - USA (nationwide and Puerto Rico) and Internationally to Australia, Austria, Belgium, Denmark, Egypt, Finland, France, Germany, Jamaica, Ireland, Israel, United Kingdom, Luxembourg, Netherlands, Norway, Sweden, Switzerland, UAE, and Canada. **Center Recommended Depth - Consumers/User**
  • Description du dispositif
    FreeStyle Blood Glucose Test Strips; || For in vitro diagnostic testing. || 50 count || UPC 6 99073 12050 2; || Freestyle Blood Glucose Test Strips; for Institutional Use only || 50 count: || UPC 6 99073 70792 5 || Manufactured by Abbott Diabetes Care Inc. Alameda, CA. || The FreeStyle Blood Glucose test strip is intended for use in the quantitative measurement of glucose in capillary whole blood from the finger, upper arm and palm. It is intended for use by healthcare professionals and people with diabetes mellitus at home as an aid in monitoring the effectiveness of a diabetes control program. It is not intended for the diagnosis of or screening for diabetes mellitus, and it is not intended for use on neonates or arterial blood.
  • Manufacturer
  • Modèle / numéro de série
    Switzerland: 70450-20 | Switzerland: 1281310, 1373413
  • Description du dispositif
    IVD: Glucose rapid test system reagent
  • Manufacturer
  • Modèle / numéro de série
  • Description du dispositif
    IVD: Glucose rapid test system analyser; Glucose rapid test system reagent; Ambulatory insulin infusion pump
  • Manufacturer