CARDIOVASCULAR PROCEDURE KIT- kit

Cardiovascular Procedure Kit by

Drug Labeling and Warnings

Cardiovascular Procedure 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

Lidocaine Hydrochloride Injection, USP is a sterile, nonpyrogenic solution of lidocaine hydrochloride in water for injection for parenteral administration in various concentrations. Multiple-dose vials contain 0.1% methylparaben added as preservative. May contain sodium hydroxide and/or hydrochloric acid for pH adjustment. The pH is 6.5 (5.0 to 7.0). Lidocaine is a local anesthetic of the amide type. Lidocaine Hydrochloride, USP is a white powder freely soluble in water. The molecular weight is 288.82. The semi-rigid vial used for the plastic vials is fabricated from a specially formulated polyolefin. 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 proper drug concentration.

Cardiovascular Procedure Kit Primary Label

MM1

PRINCIPAL DISPLAY PANEL

MM1

INGREDIENTS AND APPEARANCE

CARDIOVASCULAR PROCEDURE KIT 
cardiovascular procedure kit kit

Product Information
Product Type	MEDICAL DEVICE	Item Code (Source)	NHRIC:24840-1107

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NHRIC:24840-1107-2	10 in 1 CASE
1	NHRIC:24840-1107-1	1 in 1 PACKAGE, COMBINATION

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

Part 1 of 1

LIDOCAINE HYDROCHLORIDE 
lidocaine hydrochloride anhydrous injection, solution

Product Information
Item Code (Source)	NDC: 0409-4277
Route of Administration	INFILTRATION

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
LIDOCAINE HYDROCHLORIDE ANHYDROUS (UNII: EC2CNF7XFP) (LIDOCAINE - UNII:98PI200987)	LIDOCAINE HYDROCHLORIDE ANHYDROUS	20 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
SODIUM CHLORIDE (UNII: 451W47IQ8X)	6 mg  in 1 mL
WATER (UNII: 059QF0KO0R)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
HYDROCHLORIC ACID (UNII: QTT17582CB)
METHYLPARABEN (UNII: A2I8C7HI9T)	1 mg  in 1 mL

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0409-4277-01	20 mL in 1 VIAL, MULTI-DOSE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA088327	03/30/2010

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	repack