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. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

DESCRIPTION

Cardiovascular Kit Primary Label

MM1

Lidocaine Syringe Label

MM1

INGREDIENTS AND APPEARANCE

CARDIOVASCULAR PROCEDURE KIT 
cardiovascular procedure kit kit

Product Information
Product Type	MEDICAL DEVICE	Item Code (Source)	NHRIC:24840-1105

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NHRIC:24840-1105-2	10 in 1 CASE
1	NHRIC:24840-1105-1	1 in 1 PACKAGE, COMBINATION

Quantity of Parts
Part #	Package Quantity	Total Product Quantity
Part 1	1 SYRINGE, PLASTIC	5 mL

Part 1 of 1

LIDOCAINE HYDROCHLORIDE 
lidocaine hydrochloride injection, solution

Product Information
Item Code (Source)	NDC: 0409-9137
Route of Administration	INTRAVENOUS

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
LIDOCAINE HYDROCHLORIDE (UNII: V13007Z41A) (LIDOCAINE - UNII:98PI200987)	LIDOCAINE HYDROCHLORIDE	10 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
SODIUM HYDROXIDE (UNII: 55X04QC32I)
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM CHLORIDE (UNII: 451W47IQ8X)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0409-9137-05	5 mL in 1 SYRINGE, PLASTIC

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA040302	11/29/2010

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		093132819	manufacture