GENERAL SURGERY KIT- kit

General Surgery Kit by

Drug Labeling and Warnings

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

Drug Details [pdf]

DESCRIPTION

Bupivacaine hydrochloride is a white crystalline powder that is freely soluable in 95 percent ethanol, soluable in water and slightly soluable in chloroform or acetone. The pH of this solution is 5.5 (4.0 to 6.5) with sodium hydroxide and/or hydrochloric acid. Bupivacaine Hydrochloride is available in sterile, hyperbaric solution for subarachnoid injection. Bupivacaine Spinal does not contain preservatives.

PRINCIPAL DISPLAY PANEL

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PRINCIPAL DISPLAY PANEL

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INGREDIENTS AND APPEARANCE

GENERAL SURGERY KIT 
general surgery tray (kit) kit

Product Information
Product Type	MEDICAL DEVICE	Item Code (Source)	NHRIC:24840-1570

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NHRIC:24840-1570-2	10 in 1 CASE
1	NHRIC:24840-1570-1	1 in 1 PACKAGE, COMBINATION

Quantity of Parts
Part #	Package Quantity	Total Product Quantity
Part 1	1 AMPULE	2 mL

Part 1 of 1

BUPIVACAINE 
bupivacaine hydrochloride injection, solution

Product Information
Item Code (Source)	NDC: 0409-3613
Route of Administration	SUBARACHNOID

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
BUPIVACAINE HYDROCHLORIDE (UNII: 7TQO7W3VT8) (BUPIVACAINE - UNII:Y8335394RO)	BUPIVACAINE HYDROCHLORIDE	7.5 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
SODIUM HYDROXIDE (UNII: 55X04QC32I)
HYDROCHLORIC ACID (UNII: QTT17582CB)
ANHYDROUS DEXTROSE (UNII: 5SL0G7R0OK)	82.5 mg  in 1 mL

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0409-3613-01	2 mL in 1 AMPULE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA071810	03/23/2010

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

Labeler - Centurion Medical Products (017246562)

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 Inc		093132819	manufacture