Label: GENERAL SURGERY KIT- general surgery tray (kit)

  • NDC Code(s): 0409-6609-02, 24840-1580-1, 24840-1580-2
  • Packager: Centurion Medical Products
  • Category: MEDICAL DEVICE
  • DEA Schedule: None
  • Marketing Status: Exempt device

Drug Label Information

Updated 11/13

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  • DESCRIPTION

    Neut (4% sodium bicarbonate additive solution) is a sterile, nonpyrogenic solution of sodium bicarbonate in water for injection. It is administered by the intravenous route only after addition as a neutralizing agent to an acidic large volume parenteral solution.  Each 5 mL contains sodium bicarbonate 0.2 g (2.4 mEq each of Na+ and HCO3-); edetate disodium, anhydrous 10 mg added as a stabilizer.  Total sodium (Na+) content of each 5 mL is 56.1 mg (11.2 mg/mL).

    The solutions contain no bacteriostat, antimicrobial agent or added buffer; pH 8.0 (7.0 to 8.5).

    Sodium Bicarbonate, USP is chemically designated as NaHCO3, a white crystalline powder soluble in water.

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  • General Surgery Tray - Primary Label
  • Neut Sodium Bicarbonate
  • INGREDIENTS AND APPEARANCE
    GENERAL SURGERY KIT 
    general surgery tray (kit) kit
    Product Information
    Product Type MEDICAL DEVICE Item Code (Source) NHRIC:24840-1580
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NHRIC:24840-1580-2 10 in 1 CASE
    1 NHRIC:24840-1580-1 1 in 1 PACKAGE, COMBINATION
    Quantity of Parts
    Part # Package Quantity Total Product Quantity
    Part 1 1 VIAL 5 mL
    Part 1 of 1
    NEUT SODIUM BICARBONATE 
    sodium bicarbonate injection, solution
    Product Information
    Item Code (Source) NDC:0409-6609
    Route of Administration INTRAVENOUS DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    SODIUM BICARBONATE (BICARBONATE ION) SODIUM BICARBONATE 0.2 g  in 5 mL
    Inactive Ingredients
    Ingredient Name Strength
    water  
    EDETATE DISODIUM ANHYDROUS  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:0409-6609-02 5 mL in 1 VIAL
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    unapproved drug other 08/22/2005
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    exempt device LRO 01/01/2013
    Labeler - Centurion Medical Products (017246562)
    Establishment
    Name Address ID/FEI Business Operations
    Centurion Medical Products 017246562 manufacture, repack
    Establishment
    Name Address ID/FEI Business Operations
    Centurion Medical Products 148522279 manufacture, repack
    Establishment
    Name Address ID/FEI Business Operations
    Centurion Medical Products 626660810 manufacture, repack
    Establishment
    Name Address ID/FEI Business Operations
    Hospira 093132819 manufacture
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