CARDIOVASCULAR KIT- cardiovascular procedure kit   
Centurion Medical Products

----------

Cardiovascular Kit

DESCRIPTION

This preparation is designed for parenteral use only after addition of drugs that require dilution or must be dissolved in an aqueous vehicle prio to injection. Bacteriostatic 0.9% sodium chloride injections, USP is a sterile, nonpyrogenic, isotonic solution of sodium chloride injection in water for injection. Each mililiter (mL) contains sodium chloride 9 mg and 0.9% benzyl alcohol added as a bacteriostatic preservative. May contain hydrochloric acid for pH adjustment. It is supplied in a multiple-dose container from which repeated withdrawls may be made to dilute or dissolve drugs for medication. The pH is 5.0 (4.5 to 7.0). Sodium Chloride, USP is chemically designated NaCl, a white, crystalline powder freely soluable in water. The semi-ridgid vial is fabricated from a specially formulated plyolefin. It is a copolymer of ethylene and propylene. The safety of the plastic has been confirmed by tests in animals according to USP biological standards for plastic containers. The container requires novapor barrier to maintain the proper drug concentration.

Cardiovascular Kit Primary Label

NS-CARDIO-SC.jpg MM1

Sodium Chloride Label

Sodium Chloride.jpg MM1

CARDIOVASCULAR KIT 
cardiovascular procedure kit kit
Product Information
Product TypeMEDICAL DEVICEItem Code (Source)NHRIC:24840-1130
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NHRIC:24840-1130-210 in 1 CASE
1NHRIC:24840-1130-11 in 1 PACKAGE, COMBINATION
Quantity of Parts
Part #Package QuantityTotal Product Quantity
Part 11 VIAL, MULTI-DOSE 30 mL
Part 1 of 1
SODIUM CHLORIDE 
sodium chloride injection
Product Information
Item Code (Source)NDC:0409-1966
Route of AdministrationINTRAVENOUS
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SODIUM CHLORIDE (UNII: 451W47IQ8X) (SODIUM CATION - UNII:LYR4M0NH37, CHLORIDE ION - UNII:Q32ZN48698) SODIUM CHLORIDE9 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
BENZYL ALCOHOL (UNII: LKG8494WBH) 9 mg  in 1 mL
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0409-1966-0730 mL in 1 VIAL, MULTI-DOSE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
NDANDA01880008/19/2011
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
exempt deviceOEZ01/01/2012
Labeler - Centurion Medical Products (017246562)
Establishment
NameAddressID/FEIBusiness Operations
Centurion Medical Products017246562manufacture, repack
Establishment
NameAddressID/FEIBusiness Operations
Centurion Medical Products148522279manufacture, repack
Establishment
NameAddressID/FEIBusiness Operations
Centurion Medical Products626660810manufacture, repack
Establishment
NameAddressID/FEIBusiness Operations
Hospira, Inc.093132819manufacture

Revised: 5/2012
Document Id: bd9982c1-9023-4bc2-a408-922bc60e8847
Set id: 370ed894-7dfe-4ae0-8f9f-b13ac5c6b6b6
Version: 1
Effective Time: 20120523
 
Centurion Medical Products