OB GYN PROCEDURE KIT () KIT [CENTURION MEDICAL PRODUCTS]

OB GYN PROCEDURE KIT () KIT [CENTURION MEDICAL PRODUCTS]
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NDC 0409-1209-01, 24840-1711-1, 24840-1711-2
Set ID 081f8334-5b72-429a-b7db-cf2dcc6e1337
Category MEDICAL DEVICE
Packager Centurion Medical Products
Generic Name
Product Class alpha-Adrenergic Agonist, Amide Local Anesthetic, Antiarrhythmic, beta-Adrenergic Agonist
Product Number
Application Number OKV
  • DESCRIPTION

    Lidocaine Hydrochloride and Epinephrine Injection, USP is a sterile, nonpyrogenic solution of lidocaine hydrochloride and epinephrine in water for injection for parenteral administration. Sodium metabisulfate 0.5 mg/ml and citric acid, anhydrous 0.2 mg/ml added as stabilizers. May contain sodium hydroxide and/or hydrochloric acid to adjust pH; pH is 4.5 (3.3 to 5.5). Single dose ampuls and vial contain no bacteriostat or antimicrobial agent. Discard unused portion. Lidocaine is a local anesthetic of the amide type.

  • PRINCIPAL DISPLAY PANEL

    lidocaine and epi.jpg

  • PRINCIPAL DISPLAY PANEL

    NS-OBGYN-LIDO.jpgMM

  • INGREDIENTS AND APPEARANCE
    OB GYN PROCEDURE KIT 
    obstetrical kit kit
    Product Information
    Product TypeMEDICAL DEVICEItem Code (Source)NHRIC:24840-1711
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NHRIC:24840-1711-210 in 1 CASE
    1NHRIC:24840-1711-11 in 1 PACKAGE, COMBINATION
    Quantity of Parts
    Part #Package QuantityTotal Product Quantity
    Part 11 AMPULE 5 mL
    Part 1 of 1
    LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE 
    lidocaine hydrochloride anhydrous and epinephrine injection, solution
    Product Information
    Item Code (Source)NDC:0409-1209
    Route of AdministrationEPIDURAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    LIDOCAINE HYDROCHLORIDE ANHYDROUS (UNII: EC2CNF7XFP) (LIDOCAINE - UNII:98PI200987) LIDOCAINE HYDROCHLORIDE ANHYDROUS15 mg  in 1 mL
    EPINEPHRINE (UNII: YKH834O4BH) (EPINEPHRINE - UNII:YKH834O4BH) EPINEPHRINE5 ug  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    SODIUM CHLORIDE (UNII: 451W47IQ8X) 6.5 mg  in 1 mL
    SODIUM METABISULFITE (UNII: 4VON5FNS3C) 0.5 mg  in 1 mL
    ANHYDROUS CITRIC ACID (UNII: XF417D3PSL) 0.2 mg  in 1 mL
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    HYDROCHLORIC ACID (UNII: QTT17582CB)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0409-1209-015 mL in 1 AMPULE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA08857104/05/2010
    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
    Hospira Inc093132819manufacture