GENERAL SURGERY KIT- general surgery tray (kit)   
Centurion Medical Products

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General Surgery Kit

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.

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GENERAL SURGERY KIT 
general surgery tray (kit) kit
Product Information
Product TypeMEDICAL DEVICEItem Code (Source)NHRIC:24840-1570
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NHRIC:24840-1570-210 in 1 CASE
1NHRIC:24840-1570-11 in 1 PACKAGE, COMBINATION
Quantity of Parts
Part #Package QuantityTotal Product Quantity
Part 11 AMPULE 2 mL
Part 1 of 1
BUPIVACAINE 
bupivacaine hydrochloride injection, solution
Product Information
Item Code (Source)NDC:0409-3613
Route of AdministrationSUBARACHNOID
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BUPIVACAINE HYDROCHLORIDE (UNII: 7TQO7W3VT8) (BUPIVACAINE - UNII:Y8335394RO) BUPIVACAINE HYDROCHLORIDE7.5 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
SODIUM HYDROXIDE (UNII: 55X04QC32I)  
HYDROCHLORIC ACID (UNII: QTT17582CB)  
ANHYDROUS DEXTROSE (UNII: 5SL0G7R0OK) 82.5 mg  in 1 mL
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0409-3613-012 mL in 1 AMPULE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA07181003/23/2010
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
exempt deviceLRO01/01/2012
Labeler - Centurion Medical Products (017246562)
Establishment
NameAddressID/FEIBusiness Operations
Centurion Medical Products148522279manufacture, repack
Establishment
NameAddressID/FEIBusiness Operations
Centurion Medical Products626660810manufacture, repack
Establishment
NameAddressID/FEIBusiness Operations
Hospira Inc093132819manufacture

Revised: 9/2012
Document Id: db0e128f-b43f-44c2-ba5f-986193965755
Set id: 493569d1-291b-4d89-aa0f-17474d90aa09
Version: 1
Effective Time: 20120925
 
Centurion Medical Products