Label: CARDIOVASCULAR PROCEDURE KIT- kit
- NHRIC Code(s): 24840-1134-2, 24840-1134-1
- NDC Code(s): 0409-4888-20
- Packager: Centurion Medical Products
- Category: MEDICAL DEVICE
- DEA Schedule: None
- Marketing Status: Exempt device
Drug Label Information
Updated September 26, 2012
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DESCRIPTION
This preparation is designed solely for parenteral use only after addition of drugs that require dilution or must be dissolved in an aqueous vehicle prior to injection. 0.9% Sodium chloride injection, USP is a sterile, nonpyrogenic, isotonic solution of sodium chloride and water for injection. It contains no bacteriostat, antimicrobial agent or added buffer and is supplied only in single dose containers to dilute or dissolve drugs for injection. The solution may contain hydrochloric acid and/or sodium hydroxide for pH adjustment. pH is 5.3 (4.5 to 7.0). Sodium Chloride, USP is chemically designated NaCl, a white crystalline compound freely soluable in water.
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INGREDIENTS AND APPEARANCE
CARDIOVASCULAR PROCEDURE KIT
cardiovascular procedure kit kitProduct Information Product Type MEDICAL DEVICE Item Code (Source) NHRIC:24840-1134 Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NHRIC:24840-1134-2 10 in 1 CASE 1 NHRIC:24840-1134-1 1 in 1 PACKAGE, COMBINATION Quantity of Parts Part # Package Quantity Total Product Quantity Part 1 1 VIAL, SINGLE-DOSE 20 mL Part 1 of 1 SODIUM CHLORIDE
sodium chloride injection, solutionProduct Information Item Code (Source) NDC:0409-4888 Route of Administration INTRAVENOUS, INTRAMUSCULAR Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength SODIUM CHLORIDE (UNII: 451W47IQ8X) (SODIUM CATION - UNII:LYR4M0NH37, CHLORIDE ION - UNII:Q32ZN48698) SODIUM CHLORIDE 9 mg in 1 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) HYDROCHLORIC ACID (UNII: QTT17582CB) SODIUM HYDROXIDE (UNII: 55X04QC32I) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0409-4888-20 20 mL in 1 VIAL, SINGLE-DOSE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date NDA NDA018803 09/08/2011 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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