CARDIOVASCULAR PROCEDURE KIT-     
Centurion Medical Products

----------

Cardiovascular Procedure Kit

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 soluable in water. The molecular weight is 288.82. The semi rigid vial used for the plastic vials is fabricated from a specially formulated plyolefin. It is a copolymer of ethylene of propylene. The safety of the plastic vials 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

NS-CARDIO-LIDO.jpg MM1

Lidocaine Label

Lidocaine 10mg.jpg MM1

CARDIOVASCULAR PROCEDURE KIT 
cardiovascular procedure kit kit
Product Information
Product TypeMEDICAL DEVICEItem Code (Source)NHRIC:24840-1110
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NHRIC:24840-1110-210 in 1 CASE
1NHRIC:24840-1110-11 in 1 PACKAGE, COMBINATION
Quantity of Parts
Part #Package QuantityTotal Product Quantity
Part 11 VIAL, MULTI-DOSE 50 mL
Part 1 of 1
LIDOCAINE HYDROCHLORIDE 
lidocaine hydrochloride anhydrous injection, solution
Product Information
Item Code (Source)NDC:0409-4276
Route of AdministrationINFILTRATION
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
LIDOCAINE HYDROCHLORIDE ANHYDROUS (UNII: EC2CNF7XFP) (LIDOCAINE - UNII:98PI200987) LIDOCAINE HYDROCHLORIDE ANHYDROUS10 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
SODIUM CHLORIDE (UNII: 451W47IQ8X) 7 mg  in 1 mL
WATER (UNII: 059QF0KO0R)  
SODIUM HYDROXIDE (UNII: 55X04QC32I)  
HYDROCHLORIC ACID (UNII: QTT17582CB)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0409-4276-0250 mL in 1 VIAL, MULTI-DOSE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA08829903/30/2010
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
exempt deviceOEZ01/01/2012
Labeler - Centurion Medical Products (017246562)
Establishment
NameAddressID/FEIBusiness Operations
Centurion Medical Products017246562manufacture, repack
Establishment
NameAddressID/FEIBusiness Operations
Centurion Medical Products148522279manufacture, repack
Establishment
NameAddressID/FEIBusiness Operations
Centurion Medical Products626660810manufacture, repack
Establishment
NameAddressID/FEIBusiness Operations
Hospira, Inc093132819manufacture

Revised: 6/2012
Document Id: 8d128ed6-94f9-4da8-839b-35f578e2f645
Set id: 21d7d712-6dfc-4fd8-aa4b-70b6084b8a78
Version: 1
Effective Time: 20120601
 
Centurion Medical Products