Label: CARDIOVASCULAR PROCEDURE KIT- kit
- NHRIC Code(s): 24840-1112-2, 24840-1112-1
- NDC Code(s): 0409-3178-01
- Packager: Centurion Medical Products
- Category: MEDICAL DEVICE
- DEA Schedule: None
- Marketing Status: Exempt device
Drug Label Information
Updated September 24, 2012
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DESCRIPTION
Lidocaine Hydrochloride and Epinephrine Injection, USP is a sterile, nonpyrogenic solution of lidocaine hydrochloride and epinephrine in water for injection for parenteral administration. Sodium metabisulfate 0.5 mg/ml and citric acid, anhydrous 0.2 mg/ml added as stabilizers. May contain sodium hydroxide and/or hydrochloric acid to adjust pH; pH is 4.5 (3.3 to 5.5). Multiple dose vials contain methylbaraben 1 mg/ml added as preservative. Lidocaine is a local anesthetic of the amide type.
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INGREDIENTS AND APPEARANCE
CARDIOVASCULAR PROCEDURE KIT
cardiovascular procedure kit kitProduct Information Product Type MEDICAL DEVICE Item Code (Source) NHRIC:24840-1112 Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NHRIC:24840-1112-2 10 in 1 CASE 1 NHRIC:24840-1112-1 1 in 1 PACKAGE, COMBINATION Quantity of Parts Part # Package Quantity Total Product Quantity Part 1 1 VIAL, MULTI-DOSE 10 mL Part 1 of 1 LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE
lidocaine hydrochloride anhydrous and epinephrine injection, solutionProduct Information Item Code (Source) NDC:0409-3178 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 EPINEPHRINE (UNII: YKH834O4BH) (EPINEPHRINE - UNII:YKH834O4BH) EPINEPHRINE 10 ug in 1 mL Inactive Ingredients Ingredient Name Strength SODIUM CHLORIDE (UNII: 451W47IQ8X) 7 mg in 1 mL SODIUM METABISULFITE (UNII: 4VON5FNS3C) 0.5 mg in 1 mL ANHYDROUS CITRIC ACID (UNII: XF417D3PSL) 0.2 mg in 1 mL SODIUM HYDROXIDE (UNII: 55X04QC32I) HYDROCHLORIC ACID (UNII: QTT17582CB) METHYLPARABEN (UNII: A2I8C7HI9T) 1 mg in 1 mL WATER (UNII: 059QF0KO0R) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0409-3178-01 10 mL in 1 VIAL, MULTI-DOSE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA089644 04/05/2010 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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