CARDIOVASCULAR PROCEDURE KIT-
Centurion Medical Products

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Cardiovascular Procedure Kit

DESCRIPTION

Cardiovascular Kit Primary Label

MM1

Lidocaine Syringe Label

Lidocaine Syringe.jpg MM1

CARDIOVASCULAR PROCEDURE KIT
cardiovascular procedure kit kit

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

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

Part #	Package Quantity	Total Product Quantity
Quantity of Parts
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

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

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

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

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

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		093132819	manufacture

Revised: 5/2012

Document Id: 26464b3e-ad92-4c32-abff-624757e0dcbe

Set id: ecd30598-0c72-4c20-8562-26bb58f91da3

Version: 1

Effective Time: 20120529

Centurion Medical Products