OBGYN PROCEDURE KIT- kit

OBGYN Procedure Kit by

Drug Labeling and Warnings

OBGYN Procedure Kit by is a Other medication manufactured, distributed, or labeled by Centurion Medical Products, Hospira. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

MM1

Lidocaine Label

MM1

INGREDIENTS AND APPEARANCE

OBGYN PROCEDURE KIT 
obstetrical kit kit

Product Information
Product Type	MEDICAL DEVICE	Item Code (Source)	NHRIC:24840-1705

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NHRIC:24840-1705-2	10 in 1 CASE
1	NHRIC:24840-1705-1	1 in 1 PACKAGE, COMBINATION

Quantity of Parts
Part #	Package Quantity	Total Product Quantity
Part 1	1 SYRINGE, PLASTIC	5 mL

Part 1 of 1

LIDOCAINE HYDROCHLORIDE 
lidocaine hydrochloride injection, solution

Product Information
Item Code (Source)	NDC: 0409-9137
Route of Administration	INTRAVENOUS

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
LIDOCAINE HYDROCHLORIDE (UNII: V13007Z41A) (LIDOCAINE - UNII:98PI200987)	LIDOCAINE HYDROCHLORIDE	10 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
SODIUM HYDROXIDE (UNII: 55X04QC32I)
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM CHLORIDE (UNII: 451W47IQ8X)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0409-9137-05	5 mL in 1 SYRINGE, PLASTIC

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA040302	11/29/2010

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
exempt device	OKV	01/01/2012

Labeler - Centurion Medical Products (017246562)

Establishment
Name	Address	ID/FEI	Business Operations
Centurion Medical Products		017246562	manufacture, repack

Establishment
Name	Address	ID/FEI	Business Operations
Centurion Medical Products		148522279	manufacture, repack

Establishment
Name	Address	ID/FEI	Business Operations
Centurion Medical Products		626660810	manufacture, repack

Establishment
Name	Address	ID/FEI	Business Operations
Hospira		093132819	manufacture