CARDIOVASCULAR KIT- kit

Cardiovascular Kit by

Drug Labeling and Warnings

Cardiovascular 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

This preparation is designed for parenteral use only after addition of drugs that require dilution or must be dissolved in an aqueous vehicle prio to injection. Bacteriostatic 0.9% sodium chloride injection, USP is a sterile, nonpyrogenic, isotonic solution of sodium chloride injection in water for injection. Each mililiter (mL) contains sodium chloride 9 mg and 0.9% benzyl alcohol added as bacteriostatic preservative. May contain hydrochloric acid for pH adjustment. It is supplied in a multiple dose container from which repeated withdrawls may be made to dilute or dissolve drugs for medication. The pH is 5.0 (4.5 to 7.0). Sodium chloride, USP is chemically designated as NaCl, a while crystalline powder freely soluable in water. The semi-ridgid vial is fabricated from a specially formulated plyolefin. It is a copolymer of ethylene and propylene. The safety of the plastic has been confirmed by tests in animals according to USP biological standards for plastic containers. The container requires no vapor barrier to maintain the

Cardiovascular Kit Primary Label

MM1

Sodium Chloride Label

MM1

INGREDIENTS AND APPEARANCE

CARDIOVASCULAR KIT 
cardiovascular procedure kit kit

Product Information
Product Type	MEDICAL DEVICE	Item Code (Source)	NHRIC:24840-1131

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NHRIC:24840-1131-2	10 in 1 CASE
1	NHRIC:24840-1131-1	1 in 1 PACKAGE, COMBINATION

Quantity of Parts
Part #	Package Quantity	Total Product Quantity
Part 1	1 VIAL, MULTI-DOSE	30 mL

Part 1 of 1

SODIUM CHLORIDE 
sodium chloride injection

Product Information
Item Code (Source)	NDC: 0409-1966
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	9 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
BENZYL ALCOHOL (UNII: LKG8494WBH)	9 mg  in 1 mL
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0409-1966-14	30 mL in 1 VIAL, MULTI-DOSE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
NDA	NDA018800	08/19/2011

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