Label: CARDIOVASCULAR PROCEDURE KIT- kit

  • 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

    sodium chloride.jpgMM

  • SPL UNCLASSIFIED SECTION

    NS-CARDIO-SC.jpgMM

  • INGREDIENTS AND APPEARANCE
    CARDIOVASCULAR PROCEDURE KIT 
    cardiovascular procedure kit kit
    Product Information
    Product TypeMEDICAL DEVICEItem Code (Source)NHRIC:24840-1133
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NHRIC:24840-1133-210 in 1 CASE
    1NHRIC:24840-1133-11 in 1 PACKAGE, COMBINATION
    Quantity of Parts
    Part #Package QuantityTotal Product Quantity
    Part 11 VIAL, SINGLE-DOSE 10 mL
    Part 1 of 1
    SODIUM CHLORIDE 
    sodium chloride injection, solution
    Product Information
    Item Code (Source)NDC:0409-4888
    Route of AdministrationINTRAVENOUS, INTRAMUSCULAR
    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
    WATER (UNII: 059QF0KO0R)  
    HYDROCHLORIC ACID (UNII: QTT17582CB)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0409-4888-1010 mL in 1 VIAL, SINGLE-DOSE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    NDANDA01880309/08/2011
    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 Inc093132819manufacture