Label: CARDIOVASCULAR PROCEDURE KIT- kit

  • Category: MEDICAL DEVICE
  • DEA Schedule: None
  • Marketing Status: Exempt device

Drug Label Information

Updated September 26, 2012

If you are a consumer or patient please visit this version.

  • 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.

  • PRINCIPAL DISPLAY PANEL

    Sodium Chloride 20mL.jpgMM

  • PRINCIPAL DISPLAY PANEL

    NS-CARDIO-SC.jpgMM

  • INGREDIENTS AND APPEARANCE
    CARDIOVASCULAR PROCEDURE KIT 
    cardiovascular procedure kit kit
    Product Information
    Product TypeMEDICAL DEVICEItem Code (Source)NHRIC:24840-1134
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NHRIC:24840-1134-210 in 1 CASE
    1NHRIC:24840-1134-11 in 1 PACKAGE, COMBINATION
    Quantity of Parts
    Part #Package QuantityTotal Product Quantity
    Part 11 VIAL, SINGLE-DOSE 20 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:0409-4888-2020 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