OBGYN PROCEDURE KIT () KIT [CENTURION MEDICAL PRODUCTS]

OBGYN PROCEDURE KIT () KIT [CENTURION MEDICAL PRODUCTS]
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NDC 0409-4713-32, 24840-1702-1, 24840-1702-2
Set ID 3cdeed31-3257-435a-b83e-e39db2c5a6e0
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 lidocaine hydrochloride in water for injection for parenteral administration in various concentrations. Multiple-dose vials contain 0.1% of methylparaben added as preservative. May contain sodium hydroxide and/or cydrochloric adic for pH adjustment. The pH is 6.5 (5.0 to 7.0). Lidocaine is a local anesthetic of the amide type. Lidocaine Hydrochloride is a white powder freely soluable in water. The molecular weight is 288.82. The semi-rigid vial used for the plastic vials is fabricated from a specially formulated polyolefin. 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 no vapor barrier to maintain the proper drug concentration.

  • OBGYN Procedure Kit Primary Label

    OBGYN-LIDO.jpg MM1

  • Lidocaine Label

    Lidocaine Label.jpg MM1

  • INGREDIENTS AND APPEARANCE
    OBGYN PROCEDURE KIT 
    obstetrical kit kit
    Product Information
    Product TypeMEDICAL DEVICEItem Code (Source)NHRIC:24840-1702
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NHRIC:24840-1702-210 in 1 CASE
    1NHRIC:24840-1702-11 in 1 PACKAGE, COMBINATION
    Quantity of Parts
    Part #Package QuantityTotal Product Quantity
    Part 11 AMPULE 2 mL
    Part 1 of 1
    LIDOCAINE HYDROCHLORIDE 
    lidocaine hydrochloride anhydrous injection, solution
    Product Information
    Item Code (Source)NDC:0409-4713
    Route of AdministrationINFILTRATION
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    LIDOCAINE HYDROCHLORIDE ANHYDROUS (UNII: EC2CNF7XFP) (LIDOCAINE - UNII:98PI200987) LIDOCAINE HYDROCHLORIDE ANHYDROUS10 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    SODIUM CHLORIDE (UNII: 451W47IQ8X) 7 mg  in 1 mL
    WATER (UNII: 059QF0KO0R)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    HYDROCHLORIC ACID (UNII: QTT17582CB)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0409-4713-322 mL in 1 AMPULE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA08040803/30/2010
    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