Label: CARDIOVASCULAR KIT- kit

  • Category: MEDICAL 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

    NS-CARDIO-SC.jpg MM1

  • Sodium Chloride Label

    Sodium Chloride.jpg MM1

  • INGREDIENTS AND APPEARANCE
    CARDIOVASCULAR KIT 
    cardiovascular procedure kit kit
    Product Information
    Product TypeMEDICAL DEVICEItem Code (Source)NHRIC:24840-1130
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NHRIC:24840-1130-210 in 1 CASE
    1NHRIC:24840-1130-11 in 1 PACKAGE, COMBINATION
    Quantity of Parts
    Part #Package QuantityTotal Product Quantity
    Part 11 VIAL, MULTI-DOSE 30 mL
    Part 1 of 1
    SODIUM CHLORIDE 
    sodium chloride injection
    Product Information
    Item Code (Source)NDC:0409-1966
    Route of AdministrationINTRAVENOUS
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SODIUM CHLORIDE (UNII: 451W47IQ8X) (SODIUM CATION - UNII:LYR4M0NH37, CHLORIDE ION - UNII:Q32ZN48698) SODIUM CHLORIDE9 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    BENZYL ALCOHOL (UNII: LKG8494WBH) 9 mg  in 1 mL
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0409-1966-0730 mL in 1 VIAL, MULTI-DOSE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    NDANDA01880008/19/2011
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    exempt deviceOEZ01/01/2012
    Labeler - Centurion Medical Products (017246562)
    Establishment
    NameAddressID/FEIBusiness Operations
    Centurion Medical Products017246562manufacture, repack
    Establishment
    NameAddressID/FEIBusiness Operations
    Centurion Medical Products148522279manufacture, repack
    Establishment
    NameAddressID/FEIBusiness Operations
    Centurion Medical Products626660810manufacture, repack
    Establishment
    NameAddressID/FEIBusiness Operations
    Hospira, Inc.093132819manufacture