ENT Kit by Centurion Medical Products / Hospira ENT KIT- kit

ENT Kit by

Drug Labeling and Warnings

ENT 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

AQUEOUS SOLUTIONS FOR INFILTRATION

AND NERVE BLOCK

Ampul

Plastic Multiple-Dose Fliptop Vial

Glass Teartop Vial

Rx only

ENT Tray Primary Label

Lidocaine 1%, 20 ml Label

INGREDIENTS AND APPEARANCE

ENT KIT 
ear, nose, and throat surgical tray (kit) kit

Product Information
Product Type	MEDICAL DEVICE	Item Code (Source)	NHRIC:24840-1308

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NHRIC:24840-1308-2	1 in 1 CASE
1	NHRIC:24840-1308-1	1 in 1 PACKAGE, COMBINATION

Quantity of Parts
Part #	Package Quantity	Total Product Quantity
Part 1	1 VIAL, MULTI-DOSE	20 mL

Part 1 of 1

LIDOCAINE HYDROCHLORIDE 
lidocaine hydrochloride anhydrous injection, solution

Product Information
Item Code (Source)	NDC: 0409-4276
Route of Administration	INFILTRATION

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
LIDOCAINE HYDROCHLORIDE ANHYDROUS (UNII: EC2CNF7XFP) (LIDOCAINE - UNII:98PI200987)	LIDOCAINE HYDROCHLORIDE ANHYDROUS	10 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
SODIUM CHLORIDE (UNII: 451W47IQ8X)	7 mg  in 1 mL
Water (UNII: 059QF0KO0R)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
HYDROCHLORIC ACID (UNII: QTT17582CB)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0409-4276-01	20 mL in 1 VIAL, MULTI-DOSE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA080408	03/30/2010

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
exempt device	OGR	01/01/2013

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