OBGYN PROCEDURE KIT- obstetrical kit   
Centurion Medical Products

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OBGYN Procedure Kit

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

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

Revised: 5/2012
Document Id: 73564d5f-859f-48f2-930c-429b5e3aceba
Set id: 9aa4144d-fc1a-45a1-b69a-a5122c145d2b
Version: 1
Effective Time: 20120531
 
Centurion Medical Products