Devices

Liquid Bicarbinate

  • Modèle / numéro de série
    Lot #10442, 10461 and 10462.
  • Classification du dispositif
    Gastroenterology-Urology Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Nationwide. Product distributed to AL, AR, FL, GA, NC, SC, TN, TX, and VA.
  • Description du dispositif
    SteriLyte¿¿ Liquid Bicarbinate, Formula CL-02; 1 gallon (3.78 L); manufactured by Rockwell Medical Technologies, Inc., Grapevine, TX 76051. This product is used in conjunction with C-Series RenalPure¿¿ Liquid Acid Concentrate or DC-Series Dri-Sate¿¿ Dry Acid Concentrate in artificial kidney (hemodialysis) machines.
  • Manufacturer
    Rockwell Medical Technologies, Inc
  • 1 Event

Fabricant

Rockwell Medical Technologies, Inc
  • Adresse du fabricant
    Rockwell Medical Technologies, Inc, 4051 Freeport Pkwy Ste 100, Grapevine TX 76099
  • Société-mère du fabricant (2017)
    Rockwell Medical Inc.
  • Source
    USFDA

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Liquid Bicarbinate
  • Modèle / numéro de série
    Lot #10445.
  • Classification du dispositif
    Gastroenterology-Urology Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Nationwide. Product distributed to AL, AR, FL, GA, NC, SC, TN, TX, and VA.
  • Description du dispositif
    SteriLyte¿¿ Liquid Bicarbinate, Formula RL-01; 1 gallon (3.78 L); manufactured by Rockwell Medical Technologies, Inc., Grapevine, TX 76051. This product is used in conjunction with C-Series RenalPure¿¿ Liquid Acid Concentrate or DC-Series Dri-Sate¿¿ Dry Acid Concentrate in artificial kidney (hemodialysis) machines.
  • Manufacturer
    Rockwell Medical Technologies, Inc