Label: GENERAL SURGERY KIT- kit
- NHRIC Code(s): 24840-1535-2, 24840-1535-1
- NDC Code(s): 0409-7983-30
- Packager: Centurion Medical Products
- Category: MEDICAL DEVICE
- DEA Schedule: None
- Marketing Status: Exempt device
Drug Label Information
Updated September 27, 2012
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DESCRIPTION
0.9% Sodium Chloride Injection, USP is sterile and nonpyrogenic. It is a parenteral solution containing sodium chloride in water for injection intended for intravenous administration. Each 100 ml of 0.9% sodium chloride injection, USP contains 900 mg sodium chloride in water for injection. The pH is 5.6 (4.5 to 7.0). This solution contains no bacteriostat, antimicrobial agent or added buffer and is intended only as a single-dose injection. When smaller doses are required, the unused portion should be discarded. 0.9% Sodium Chloride is a parenteral fluid and electolyte replenisher and is a white crystalline powder freely soluable in water.
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INGREDIENTS AND APPEARANCE
GENERAL SURGERY KIT
general surgery tray (kit) kitProduct Information Product Type MEDICAL DEVICE Item Code (Source) NHRIC:24840-1535 Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NHRIC:24840-1535-2 10 in 1 CASE 1 NHRIC:24840-1535-1 1 in 1 PACKAGE, COMBINATION Quantity of Parts Part # Package Quantity Total Product Quantity Part 1 1 BAG 500 mL Part 1 of 1 SODIUM CHLORIDE
sodium chloride injection, solutionProduct Information Item Code (Source) NDC:0409-7983 Route of Administration INTRAVENOUS Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength SODIUM CHLORIDE (UNII: 451W47IQ8X) (SODIUM CATION - UNII:LYR4M0NH37, CHLORIDE ION - UNII:Q32ZN48698) SODIUM CHLORIDE 900 mg in 100 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0409-7983-30 500 mL in 1 BAG Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA016366 04/10/2006 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 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 Inc 093132819 manufacture
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