DESCRIPTION

This preparation is designed solely for parenteral use only after addition of drugs that require dilution or must be dissolved in an aqueous vehicle prior to injection. 0.9% Sodium chloride injection, USP is a sterile, nonpyrogenic, isotonic solution of sodium chloride and water for injection. It contains no bacteriostat, antimicrobial agent or added buffer and is supplied only in single dose containers to dilute or dissolve drugs for injection. The solution may contain hydrochloric acid and/or sodium hydroxide for pH adjustment. pH is 5.3 (4.5 to 7.0). Sodium Chloride, USP is chemically designated NaCl, a white crystalline compound freely soluable in water.

Sodium Chloride 20mL.jpg MM

CARDIOVASCULAR PROCEDURE KIT
cardiovascular procedure kit kit

Product Information
Product Type	MEDICAL DEVICE	Item Code (Source)	NHRIC:24840-1134

#	Item Code	Package Description
Packaging
1	NHRIC:24840-1134-2	10 in 1 CASE
1	NHRIC:24840-1134-1	1 in 1 PACKAGE, COMBINATION

Part #	Package Quantity	Total Product Quantity
Quantity of Parts
Part 1	1 VIAL, SINGLE-DOSE	20 mL

Part 1 of 1

SODIUM CHLORIDE
sodium chloride injection, solution

Product Information
Item Code (Source)	NDC:0409-4888
Route of Administration	INTRAVENOUS, INTRAMUSCULAR

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
SODIUM CHLORIDE (UNII: 451W47IQ8X) (SODIUM CATION - UNII:LYR4M0NH37, CHLORIDE ION - UNII:Q32ZN48698)	SODIUM CHLORIDE	9 mg in 1 mL

Ingredient Name	Strength
Inactive Ingredients
WATER (UNII: 059QF0KO0R)
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:0409-4888-20	20 mL in 1 VIAL, SINGLE-DOSE

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
NDA	NDA018803	09/08/2011

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

Labeler - Centurion Medical Products (017246562)

Name	Address	ID/FEI	Business Operations
Establishment
Centurion Medical Products		017246562	manufacture, repack

Name	Address	ID/FEI	Business Operations
Establishment
Centurion Medical Products		148522279	manufacture, repack

Name	Address	ID/FEI	Business Operations
Establishment
Centurion Medical Products		626660810	manufacture, repack

Name	Address	ID/FEI	Business Operations
Establishment
Hospira Inc		093132819	manufacture

Cardiovascular Procedure Kit

DESCRIPTION