CARDIOVASCULAR KIT- kit

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

SODIUM CHLORIDE (UNII: 451W47IQ8X) (SODIUM CATION - UNII:LYR4M0NH37, CHLORIDE ION - UNII:Q32ZN48698)

Available from:

Centurion Medical Products

INN (International Name):

SODIUM CHLORIDE

Composition:

SODIUM CHLORIDE 9 mg in 1 mL

Therapeutic indications:

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

Authorization status:

Exempt device

Summary of Product characteristics

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
MM1
SODIUM CHLORIDE LABEL
MM1
CARDIOVASCULAR KIT
cardiovascular procedure kit kit
PRODUCT INFORMATION
PRODUCT T YPE
MEDICAL DEVICE
ITE M CODE (SOURCE )
NHRIC:248 40 -1130
PACKAG ING
#
ITEM CODE
PACKAGE DESCRIPTION
MARKETING START DATE
MARKETING END DATE
1
NHRIC:248 40 -1130 -2
10 in 1 CASE
1
NHRIC:248 40 -1130 -1
1 in 1 PACKAGE, COMBINATION
QUANTITY OF PARTS
PART #
PACKAGE QUANTITY
TOTAL PRODUCT QUANTITY
PA RT 1
1 VIAL, MULTI-DOSE
30 mL
PART 1 OF 1
SODIUM CHLORIDE
sodium chloride injection
PRODUCT INFORMATION
ITE M CODE (SOURCE )
NDC:0 40 9 -19 6 6
ROUTE OF ADMINISTRATION
INTRAVENOUS
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