OBGYN PROCEDURE KIT () KIT [CENTURION MEDICAL PRODUCTS]

OBGYN PROCEDURE KIT () KIT [CENTURION MEDICAL PRODUCTS]
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NDC 0409-9137-05, 24840-1705-1, 24840-1705-2
Set ID 9aa4144d-fc1a-45a1-b69a-a5122c145d2b
Category MEDICAL DEVICE
Packager Centurion Medical Products
Generic Name
Product Class Amide Local Anesthetic, Antiarrhythmic
Product Number
Application Number OKV
  • DESCRIPTION

    Lidocaine Hydrochloride Injection, USP is a sterile, nonpyrogenic solution of an antriarrhythmic agent administered interavenously by either direct injection or continuous infusion. It is available in the following concentration: 5mL (100 mg), 6.0 (5.0 to 7.0) pH. May contain sodium hydroxide and/or hydrocholoric acid for pH adjustment. Injections containing 10 mg/mL (1%) contain sodium chloride 7 mg and injections containing 20 mg/mL (2%) lidocaine hydrochloride contain sodium chloride 6 mg to adjust tonicity. Single dose solutions contain no preservative and unused portions must be discarded after use. Lidocaine Hydrochloride, USP is a white powder freely soluable in water. The molecular weight is 288.82. The plastic syringe is molded from a specially formulated polypropylene. Water permeates from inside the container at an extremely slow rate which will have an insignificant effect on solution concentration over the expected shelf life. Solutions in contact with the plastic container may leach out certain chemical components from the plastic in very small amounts; however, biological testing was supportive of the safety of the syringe material.

  • OBGYN Procedure Kit Primary Label

    NS-OBGYN-LIDO.jpg MM1

  • Lidocaine Label

    Lidocaine Syringe.jpg MM1

  • INGREDIENTS AND APPEARANCE
    OBGYN PROCEDURE KIT 
    obstetrical kit kit
    Product Information
    Product TypeMEDICAL DEVICEItem Code (Source)NHRIC:24840-1705
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NHRIC:24840-1705-210 in 1 CASE
    1NHRIC:24840-1705-11 in 1 PACKAGE, COMBINATION
    Quantity of Parts
    Part #Package QuantityTotal Product Quantity
    Part 11 SYRINGE, PLASTIC 5 mL
    Part 1 of 1
    LIDOCAINE HYDROCHLORIDE 
    lidocaine hydrochloride injection, solution
    Product Information
    Item Code (Source)NDC:0409-9137
    Route of AdministrationINTRAVENOUS
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    LIDOCAINE HYDROCHLORIDE (UNII: V13007Z41A) (LIDOCAINE - UNII:98PI200987) LIDOCAINE HYDROCHLORIDE10 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    HYDROCHLORIC ACID (UNII: QTT17582CB)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0409-9137-055 mL in 1 SYRINGE, PLASTIC
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA04030211/29/2010
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    exempt deviceOKV01/01/2012
    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
    Hospira093132819manufacture