Label: GENERAL SURGERY KIT- kit
- NHRIC Code(s): 24840-1570-2, 24840-1570-1
- NDC Code(s): 0409-3613-01
- Packager: Centurion Medical Products
- Category: MEDICAL DEVICE
- DEA Schedule: None
- Marketing Status: Exempt device
Drug Label Information
Updated September 25, 2012
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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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INGREDIENTS AND APPEARANCE
GENERAL SURGERY KIT
general surgery tray (kit) kitProduct 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, solutionProduct 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
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