Country: মার্কিন যুক্তরাষ্ট্র
ভাষা: ইংরেজি
সূত্র: NLM (National Library of Medicine)
SODIUM CHLORIDE (UNII: 451W47IQ8X) (SODIUM CATION - UNII:LYR4M0NH37, CHLORIDE ION - UNII:Q32ZN48698)
Centurion Medical Products
SODIUM CHLORIDE
SODIUM CHLORIDE 9 mg in 1 mL
This preparation is designed solely for parenteral use only after addition of drugs that require dilution or must be dissolved in an aqueous vehicle prior to injection. 0.9% Sodium chloride injection, USP is a sterile, nonpyrogenic, isotonic solution of sodium chloride and water for injection. It contains no bacteriostat, antimicrobial agent or added buffer and is supplied only in single dose containers to dilute or dissolve drugs for injection. The solution may contain hydrochloric acid and/or sodium hydroxide for pH adjustment. pH is 5.3 (4.5 to 7.0). Sodium Chloride, USP is chemically designated NaCl, a white crystalline compound freely soluable in water.
Exempt device
CARDIOVASCULAR PROCEDURE KIT- CENTURION MEDICAL PRODUCTS ---------- CARDIOVASCULAR PROCEDURE KIT DESCRIPTION This preparation is designed solely for parenteral use only after addition of drugs that require dilution or must be dissolved in an aqueous vehicle prior to injection. 0.9% Sodium chloride injection, USP is a sterile, nonpyrogenic, isotonic solution of sodium chloride and water for injection. It contains no bacteriostat, antimicrobial agent or added buffer and is supplied only in single dose containers to dilute or dissolve drugs for injection. The solution may contain hydrochloric acid and/or sodium hydroxide for pH adjustment. pH is 5.3 (4.5 to 7.0). Sodium Chloride, USP is chemically designated NaCl, a white crystalline compound freely soluable in water. MM MM CARDIOVASCULAR PROCEDURE KIT cardiovascular procedure kit kit PRODUCT INFORMATION PRODUCT T YPE MEDICAL DEVICE ITE M CODE (SOURCE ) NHRIC:248 40 -1134 PACKAG ING # ITEM CODE PACKAGE DESCRIPTION MARKETING START DATE MARKETING END DATE 1 NHRIC:248 40 -1134-2 10 in 1 CASE 1 NHRIC:248 40 -1134-1 1 in 1 PACKAGE, COMBINATION QUANTITY OF PARTS PART # PACKAGE QUANTITY TOTAL PRODUCT QUANTITY PA RT 1 1 VIAL, SINGLE-DOSE 20 mL PART 1 OF 1 SODIUM CHLORIDE sodium chloride injection, solution PRODUCT INFORMATION ITE M CODE (SOURCE ) NDC:0 40 9 -48 8 8 ROUTE OF ADMINISTRATION INTRAVENOUS, INTRAMUSCULAR ACTIVE INGREDIENT/ACTIVE MOIETY INGREDIENT NAME BASIS OF STRE NG TH STRE NG TH SO DIUM CHLO RIDE (UNII: 451W47IQ8 X) (SODIUM CATION - UNII:LYR4M0 NH37, CHLORIDE ION - UNII:Q32ZN48 6 9 8 ) SODIUM CHLORIDE 9 mg in 1 mL INACTIVE INGREDIENTS INGREDIENT NAME STRE NG TH WATER (UNII: 0 59 QF0 KO0 R) HYDRO CHLO RIC ACID (UNII: QTT1758 2CB) SO DIUM HYDRO XIDE (UNII: 55X0 4QC32I) Centurion Medical Products PACKAG ING # ITEM CODE PACKAGE DESCRIPTION MARKETING START DATE MARKETING END DATE 1 NDC:0 40 9 -48 8 8 -20 20 mL in 1 VIAL, SINGLE-DOSE MARKETING INFORMATION MARKE TING CATE GORY APPLICATION NUMBE R OR MONOGRAPH CITATION MARKE TING START DATE MARKE TING END DATE NDA NDA সম্পূর্ণ নথি পড়ুন