CARDIOVASCULAR PROCEDURE KIT-     
Centurion Medical Products

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Cardiovascular ProcedureKit

Drug Description

AQUEOUS SOLUTIONS FOR INFILTRATION

AND NERVE BLOCK

Ampul

Plastic Multiple-dose Fliptop Vial

Glass Teartop Vial

Rx only

DESCRIPTION

Lidocaine Hydrochloride Injection, USP is a sterile, nonpyrogenic solution of lidocaine hydrochloride in water for injection for parenteral administration in various concentrations with characteristics as follows:

Concentration 0.5% 1% 1.5% 2%

mg/mL lidocaine HCl (anhyd.) 5 10 15 20

mg/mL sodium chloride 8 7 6.5 6

Multiple-dose vials contain 0.1% of 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 chemically designated 2-(diethylamino)-N-(2,6-dimethylphenyl)-acetamide monohydrochloride monohydrate, a white powder freely soluble in water. The molecular weight is 288.82.

Cardiovascular Procedure Kit - Primary Label

MM1 Cardio-LIDO.jpg

CARDIOVASCULAR PROCEDURE KIT 
cardiovascular procedure kit kit
Product Information
Product TypeMEDICAL DEVICEItem Code (Source)NHRIC:24840-1102
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NHRIC:24840-1102-210 in 1 CASE
1NHRIC:24840-1102-11 in 1 PACKAGE, COMBINATION
Quantity of Parts
Part #Package QuantityTotal Product Quantity
Part 11 AMPULE 2 mL
Part 1 of 1
LIDOCAINE HYDROCHLORIDE 
lidocaine hydrochloride anhydrous injection, solution
Product Information
Item Code (Source)NDC:0409-4713
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)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0409-4713-322 mL in 1 AMPULE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA08040803/30/2010
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
exempt deviceOEZ03/02/2012
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
Hospira093132819manufacture

Revised: 3/2012
Document Id: aead7c0a-7ade-41b2-83ac-5bb2a96b10e9
Set id: e50dba2b-a74c-4197-9ac4-dbd211bc2ac4
Version: 1
Effective Time: 20120314
 
Centurion Medical Products