GENERAL SURGERY KIT- general surgery tray (kit)

United States - English - NLM (National Library of Medicine)

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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 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.
Authorization status:
Exempt device
Authorization number:
0409-4888-20, 24840-1534-1, 24840-1534-2

GENERAL SURGERY KIT- general surgery tray (kit)

Centurion Medical Products

----------

General Surgery 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.

General Surgery Kit Label

GENERAL SURGERY KIT

general surgery tray (kit) kit

Product Information

Product T ype

MEDICAL DEVICE

Ite m Code (Source )

NHRIC:248 40 -1534

Packag ing

#

Item Code

Package Description

Marketing Start Date

Marketing End Date

1

NHRIC:248 40 -1534-2

10 in 1 CASE

1

NHRIC:248 40 -1534-1

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

NDA0 18 8 0 3

0 9 /0 8 /20 11

Marketing Information

Marke ting Cate gory

Application Numbe r or Monograph Citation

Marke ting Start Date

Marke ting End Date

exempt device

0 1/0 1/20 12

Labeler -

Centurion Medical Products (017246562)

Establishment

Name

Ad d re s s

ID/FEI

Busine ss Ope rations

Centurio n Medical Pro ducts

0 17246 56 2

manufacture, repack

Establishment

Name

Ad d re s s

ID/FEI

Busine ss Ope rations

Centurio n Medical Pro ducts

148 522279

manufacture, repack

Establishment

Name

Ad d re s s

ID/FEI

Busine ss Ope rations

Centurio n Medical Pro ducts

6 26 6 6 0 8 10

manufacture, repack

Establishment

Name

Ad d re s s

ID/FEI

Busine ss Ope rations

Ho spira Inc

0 9 31328 19

ma nufa c ture

Revised: 9/2012

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