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Name:Helium
Manufacturer:Linde Llc
Category:Prescription Marketed Drugs


Helium Bulk Liquid

HELIUM - helium gas 
Linde LLC

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Helium Bulk Liquid

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

 

 

label

Helium USP Certificate of Analysis

Product:

Helium, USP

Date

 

Facility Name

 

Facility Address

 

Lot #

 

Batch #

 

Final Analysis Results

Analyzer #

Test / Units

USP Specs

Analysis Results

GC1

% Helium Assay

> 99.0%

%

GC1

% Air

< 1.0%

 

                   ppm N2

 

  ppm O2

Drager Tube

ppm CO

< 10 ppm

                  ppm

N/A

Odor

None

 

N/A

Identification

Pass

 

NT = not tested The methodology used to perform the assay and air USP tests:1The assay and air determinations are performed using a Gow-Mac Gas Chromatograph  Manufacturer Model: #590-1 or a Valco Gas Chromatograph Manufacturer Model: #5000

Analyst

Date

 

 

Quality Reviewer

Date

 

 

Should the material not be delivered to a USP customer, the material is “Not Approved for Human Drug Use.”  
 July 2010
Helium USP Certificate of Analysis
Page 1 of 1

Copyright © The Linde Group – Distributed by a locally registered Linde company

 


HELIUM  
helium gas
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:52438-015
Route of Administration RESPIRATORY (INHALATION) DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Helium (Helium) Helium 990 mL  in 1 L
Product Characteristics
Color      Score     
Shape Size
Flavor Imprint Code
Contains     
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:52438-015-20 41635 L in 1 TANK None

Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
unapproved medical gas 08/26/1965

Labeler - Linde LLC (001368141)
Establishment
Name Address ID/FEI Operations
Linde LLC 021877628 MANUFACTURE

Revised: 08/2010 Linde LLC



Source: http://dailymed.nlm.nih.gov
Reproduced with permission of U.S. National Library of Medicine


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