GENERAL SURGERY KIT- kit

General Surgery Kit by

Drug Labeling and Warnings

General Surgery Kit by is a Other medication manufactured, distributed, or labeled by Centurion Medical Products, Hospira. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

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

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