Label: GENERAL SURGERY KIT- kit
- NHRIC Code(s): 24840-1580-2, 24840-1580-1
- NDC Code(s): 0409-6609-02
- Packager: Centurion Medical Products
- Category: MEDICAL DEVICE
- DEA Schedule: None
- Marketing Status: Exempt device
Drug Label Information
Updated November 12, 2013
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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.
- General Surgery Tray - Primary Label
- Neut Sodium Bicarbonate
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INGREDIENTS AND APPEARANCE
GENERAL SURGERY KIT
general surgery tray (kit) kitProduct 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, solutionProduct Information Item Code (Source) NDC:0409-6609 Route of Administration INTRAVENOUS Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength SODIUM BICARBONATE (UNII: 8MDF5V39QO) (BICARBONATE ION - UNII:HN1ZRA3Q20) SODIUM BICARBONATE 0.2 g in 5 mL Inactive Ingredients Ingredient Name Strength water (UNII: 059QF0KO0R) EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM) 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
