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 Inc. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

DESCRIPTION

0.9% Sodium Chloride Injection, USP is sterile and nonpyrogenic. It is a parenteral solution containing sodium chloride in water for injection intended for intravenous administration. Each 100 ml of 0.9% sodium chloride injection, USP contains 900 mg sodium chloride in water for injection. The pH is 5.6 (4.5 to 7.0). This solution contains no bacteriostat, antimicrobial agent or added buffer and is intended only as a single-dose injection. When smaller doses are required, the unused portion should be discarded. 0.9% Sodium Chloride is a parenteral fluid and electolyte replenisher and is a white crystalline powder freely soluable in water.

PRINCIPAL DISPLAY PANEL

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PRINCIPAL DISPLAY PANEL

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INGREDIENTS AND APPEARANCE

GENERAL SURGERY KIT 
general surgery tray (kit) kit

Product Information
Product Type	MEDICAL DEVICE	Item Code (Source)	NHRIC:24840-1535

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NHRIC:24840-1535-2	10 in 1 CASE
1	NHRIC:24840-1535-1	1 in 1 PACKAGE, COMBINATION

Quantity of Parts
Part #	Package Quantity	Total Product Quantity
Part 1	1 BAG	500 mL

Part 1 of 1

SODIUM CHLORIDE 
sodium chloride injection, solution

Product Information
Item Code (Source)	NDC: 0409-7983
Route of Administration	INTRAVENOUS

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SODIUM CHLORIDE (UNII: 451W47IQ8X) (SODIUM CATION - UNII:LYR4M0NH37, CHLORIDE ION - UNII:Q32ZN48698)	SODIUM CHLORIDE	900 mg  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0409-7983-30	500 mL in 1 BAG

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA016366	04/10/2006

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
exempt device	LRO	01/01/2012

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 Inc		093132819	manufacture