Label: CARDIOVASCULAR PROCEDURE KIT- kit
- NHRIC Code(s): 24840-1133-2, 24840-1133-1
- NDC Code(s): 0409-4888-10
- 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, non-pyrogenic 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 5.0 (4.5 to 7.0). Sodium Chloride, USP is chemically designated NaCl, a white crystalline compound freely soluable in water.
- Sodium Chloride Label
- SPL UNCLASSIFIED SECTION
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INGREDIENTS AND APPEARANCE
CARDIOVASCULAR PROCEDURE KIT
cardiovascular procedure kit kitProduct Information Product Type MEDICAL DEVICE Item Code (Source) NHRIC:24840-1133 Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NHRIC:24840-1133-2 10 in 1 CASE 1 NHRIC:24840-1133-1 1 in 1 PACKAGE, COMBINATION Quantity of Parts Part # Package Quantity Total Product Quantity Part 1 1 VIAL, SINGLE-DOSE 10 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:0409-4888-10 10 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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