Label: CARDIOVASCULAR PROCEDURE KIT- kit
- NHRIC Code(s): 24840-1110-2, 24840-1110-1
- NDC Code(s): 0409-4276-02
- Packager: Centurion Medical Products
- Category: MEDICAL DEVICE
Drug Label Information
Updated June 1, 2012
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- Official Label (Printer Friendly)
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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
- Lidocaine Label
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INGREDIENTS AND APPEARANCE
CARDIOVASCULAR PROCEDURE KIT
cardiovascular procedure kit kitProduct Information Product Type MEDICAL DEVICE Item Code (Source) NHRIC:24840-1110 Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NHRIC:24840-1110-2 10 in 1 CASE 1 NHRIC:24840-1110-1 1 in 1 PACKAGE, COMBINATION Quantity of Parts Part # Package Quantity Total Product Quantity Part 1 1 VIAL, MULTI-DOSE 50 mL Part 1 of 1 LIDOCAINE HYDROCHLORIDE
lidocaine hydrochloride anhydrous injection, solutionProduct Information Item Code (Source) NDC:0409-4276 Route of Administration INFILTRATION Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength LIDOCAINE HYDROCHLORIDE ANHYDROUS (UNII: EC2CNF7XFP) (LIDOCAINE - UNII:98PI200987) LIDOCAINE HYDROCHLORIDE ANHYDROUS 10 mg in 1 mL Inactive Ingredients Ingredient Name Strength 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 Code Package Description Marketing Start Date Marketing End Date 1 NDC:0409-4276-02 50 mL in 1 VIAL, MULTI-DOSE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA088299 03/30/2010 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, Inc 093132819 manufacture
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