Your browser does not support JavaScript! GENERAL SURGERY KIT () KIT [CENTURION MEDICAL PRODUCTS]
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GENERAL SURGERY KIT () kit
[Centurion Medical Products]


Category DEA Schedule Marketing Status
MEDICAL DEVICE Exempt device
Drug Label Sections

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 TypeMEDICAL DEVICEItem Code (Source)NHRIC:24840-1580
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NHRIC:24840-1580-210 in 1 CASE
1NHRIC:24840-1580-11 in 1 PACKAGE, COMBINATION
Quantity of Parts
Part #Package QuantityTotal Product Quantity
Part 11 VIAL 5 mL
Part 1 of 1
NEUT SODIUM BICARBONATE 
sodium bicarbonate injection, solution
Product Information
Item Code (Source)NDC:0409-6609
Route of AdministrationINTRAVENOUSDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SODIUM BICARBONATE (BICARBONATE ION) SODIUM BICARBONATE0.2 g  in 5 mL
Inactive Ingredients
Ingredient NameStrength
water 
EDETATE DISODIUM ANHYDROUS 
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0409-6609-025 mL in 1 VIAL
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved drug other08/22/2005
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
exempt deviceLRO01/01/2013
Labeler - Centurion Medical Products (017246562)
Establishment
NameAddressID/FEIBusiness Operations
Centurion Medical Products017246562manufacture, repack
Establishment
NameAddressID/FEIBusiness Operations
Centurion Medical Products148522279manufacture, repack
Establishment
NameAddressID/FEIBusiness Operations
Centurion Medical Products626660810manufacture, repack
Establishment
NameAddressID/FEIBusiness Operations
Hospira093132819manufacture

Revised: 11/2013
 
Centurion Medical Products

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