GENERAL SURGERY KIT- general surgery tray (kit)   
Centurion Medical Products

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General Surgery Tray

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

NS-GSURGERY-SB.jpg

Neut Sodium Bicarbonate

neut-4-pct-sodium-bicarbonate-additive-solution-1-figure-1-jRL-0672.jpg

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 (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

Revised: 11/2013
Document Id: 2199ecf8-3be1-40bd-b531-e10d90d69ebd
Set id: 41735bcb-602f-49a0-b578-18c1bdb33d03
Version: 1
Effective Time: 20131112
 
Centurion Medical Products