CARDIOVASCULAR PROCEDURE KIT-     
Centurion Medical Products

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Cardiovascular Procedure Kit

Cardiovascular Procedure Kit - Primary Label

MM1 Cardio-LIDO.jpg

DESCRIPTION

Xylocaine (lidocaine HCl) Injections are sterile, nonpyrogenic, aqueous solutions that contain a local anesthetic agent with or without epinephrine and are administered parenterally by injection.

Xylocaine solutions contain lidocaine HCl, which is chemically designated as acetamide, 2-(diethylamino)-N-(2,6-dimethylphenyl)-, monohydrochloride and has the molecular wt. 270.8.

Epinephrine is (-) -3, 4-Dihydroxy-α-[(methylamino) methyl] benzyl alcohol and has the molecular wt. 183.21.

Xylocaine MPF is a sterile, nonpyrogenic, isotonic solution containing sodium chloride. Xylocaine in multiple dose vials: Each mL also contains 1 mg methyl­paraben as antiseptic preservative. The pH of these solutions is adjusted to approximately 6.5 (5.0 to 7.0) with sodium hydroxide and/or hydrochloric acid.

Xylocaine MPF with Epinephrine is a sterile, nonpyrogenic, isotonic solution containing sodium chloride. Each mL contains lidocaine hydrochloride and epinephrine, with 0.5 mg sodium metabisulfite as an antioxidant and 0.2 mg citric acid as a stabilizer. Xylocaine with Epinephrine in multiple dose vials: Each mL also contains 1 mg methylparaben as antiseptic preservative. The pH of these solutions is adjusted to approximately 4.5 (3.3 to 5.5) with sodium hydroxide and/or hydrochloric acid.

CARDIOVASCULAR PROCEDURE KIT 
cardiovascular procedure kit kit
Product Information
Product TypeMEDICAL DEVICEItem Code (Source)NHRIC:24840-1106
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NHRIC:24840-1106-210 in 1 CASE
1NHRIC:24840-1106-11 in 1 PACKAGE, COMBINATION
Quantity of Parts
Part #Package QuantityTotal Product Quantity
Part 11 VIAL, MULTI-DOSE 10 mL
Part 1 of 1
XYLOCAINE 
lidocaine hydrochloride injection, solution
Product Information
Item Code (Source)NDC:63323-486
Route of AdministrationINFILTRATION
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
LIDOCAINE HYDROCHLORIDE (UNII: V13007Z41A) (LIDOCAINE - UNII:98PI200987) LIDOCAINE HYDROCHLORIDE20 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
SODIUM CHLORIDE (UNII: 451W47IQ8X) 6 mg  in 1 mL
METHYLPARABEN (UNII: A2I8C7HI9T) 1 mg  in 1 mL
SODIUM HYDROXIDE (UNII: 55X04QC32I)  
HYDROCHLORIC ACID (UNII: QTT17582CB)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:63323-486-1710 mL in 1 VIAL, MULTI-DOSE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
NDANDA00648808/12/2010
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
exempt deviceOEZ01/01/2011
Labeler - Centurion Medical Products (017246562)
Establishment
NameAddressID/FEIBusiness Operations
Centurion Medical Products148522279manufacture, repack
Establishment
NameAddressID/FEIBusiness Operations
APP Pharmaceuticals, LLC023648251manufacture

Revised: 3/2012
Document Id: f9fb1071-851e-4b26-91db-909e0b048795
Set id: eed8f49f-3676-42ee-b86c-72f338818097
Version: 1
Effective Time: 20120315
 
Centurion Medical Products