Label: CARDIOVASCULAR KIT- kit
- NHRIC Code(s): 24840-1130-2, 24840-1130-1
- NDC Code(s): 0409-1966-07
- Packager: Centurion Medical Products
- Category: MEDICAL DEVICE
- DEA Schedule: None
- Marketing Status: Exempt device
Drug Label Information
Updated May 23, 2012
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DESCRIPTION
This preparation is designed for parenteral use only after addition of drugs that require dilution or must be dissolved in an aqueous vehicle prio to injection. Bacteriostatic 0.9% sodium chloride injections, USP is a sterile, nonpyrogenic, isotonic solution of sodium chloride injection in water for injection. Each mililiter (mL) contains sodium chloride 9 mg and 0.9% benzyl alcohol added as a bacteriostatic preservative. May contain hydrochloric acid for pH adjustment. It is supplied in a multiple-dose container from which repeated withdrawls may be made to dilute or dissolve drugs for medication. The pH is 5.0 (4.5 to 7.0). Sodium Chloride, USP is chemically designated NaCl, a white, crystalline powder freely soluable in water. The semi-ridgid vial is fabricated from a specially formulated plyolefin. It is a copolymer of ethylene and propylene. The safety of the plastic has been confirmed by tests in animals according to USP biological standards for plastic containers. The container requires novapor barrier to maintain the proper drug concentration.
- Cardiovascular Kit Primary Label
- Sodium Chloride Label
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INGREDIENTS AND APPEARANCE
CARDIOVASCULAR KIT
cardiovascular procedure kit kitProduct Information Product Type MEDICAL DEVICE Item Code (Source) NHRIC:24840-1130 Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NHRIC:24840-1130-2 10 in 1 CASE 1 NHRIC:24840-1130-1 1 in 1 PACKAGE, COMBINATION Quantity of Parts Part # Package Quantity Total Product Quantity Part 1 1 VIAL, MULTI-DOSE 30 mL Part 1 of 1 SODIUM CHLORIDE
sodium chloride injectionProduct Information Item Code (Source) NDC:0409-1966 Route of Administration INTRAVENOUS 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 BENZYL ALCOHOL (UNII: LKG8494WBH) 9 mg in 1 mL WATER (UNII: 059QF0KO0R) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0409-1966-07 30 mL in 1 VIAL, MULTI-DOSE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date NDA NDA018800 08/19/2011 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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