Your browser does not support JavaScript! NITROGEN GAS [ASPEN AIR US CORP]
DailyMed Logo Header image

Daily Med

Current Medication Information

Options

RxNorm Names

NITROGEN gas
[Aspen Air US Corp]


Category DEA Schedule Marketing Status
HUMAN PRESCRIPTION DRUG LABEL unapproved medical gas
NOTE:THIS DRUG HAS NOT BEEN FOUND BY FDA TO BE SAFE AND EFFECTIVE, AND THIS LABELING HAS NOT BEEN APPROVED BY FDA. For further information about unapproved drugs, click here.
Drug Label Sections

NITROGEN CERTIFICATE OF ANALYSIS

THIS DOCUMENT IS THE CERTIFICATE OF ANALYSIS OF NITROGEN NF LOT # ______________________ SUPPLIED TO YOU IN A TRAILER FROM OUR BILLINGS MONTANA LOCATION OR PICKED UP BY THE CUSTOMER LISTED ABOVE IN THEIR TRAILER.  FOLLOWING THE ASPEN AIR MEDICAL GAS PROCEDURES OUR LOCATION ENSURES THAT THE OXYGEN USP PRODUCT IS MANUFACTURED IN COMPLIANCE WITH THE FDA'S CURRENT GOOD MANUFACTURING PRACTICE REGULATIONS AND THE FDA'S MEDICAL GAS GUIDELINES.  THIS DOCUMENT IS INTENDED TO SERVE AS A CERTIFICATE OF ANALYSIS FOR THE OXYGEN USP WHEN THE RESULTS OF THE PRODUCT TESTING ARE ENTERED BELOW AND THE PRODUCT HAS BEEN DELIVERED TO A REGISTERED OXYGEN USP CUSTOMER.  THIS DOCUMENT IS IN COMPLIANCE WITH CURRENT FDA GUIDANCE

TEST                      SPECIFICATIONS                    RESULTS

ASSAY                    GREATER THAN 99.998%

IDENTIFICATION    NITROGEN

ODOR                        NONE

OXYGEN             LESS THAN 0.001%

CARBON MONOXIDE    LESS THAN 0.001%

THE METHODOLOGY USED FOR PERFORMING THE USP TEST FOR ASSAY AND IDENTIFICATION IS THE PARAMAGNETIC ANALYZER MODEL # TELEDYNE 2010 MA.  THIS ANALYZER HAS BEEN VALIDATED AS AN ACCEPTABLE ALTERNATIVE TO THE OFFICIAL USP METHOD FOR OXYGEN ASSAY AND IDENTIFICATION.  THE VALIDATION STUDY IS AVAILABLE FOR REVIEW UPON REQUEST.  ODOR TESTING WAS PERFORMED BY THE OLFACTORY METHOD.  SUPPLIER SIGNATURE _________________________ DATE _________________

NUMBER 33 110 A1 - REVISION DATE 05/01/08

NITROGEN COA

GENERAL PRECAUTIONS

If this NITROGEN NF is not delivered to a properly registered
user the product is “Not approved for human drug use”.

This product has been produced by the air liquefaction
process and is exempt from these tests as stated in the USP / NF monograph for
NITROGEN

FOR ALL NITROGEN N INSTALLATIONS THE DRIVER SHALL ENSURE AND DOCUMENT THE FOLLOWING: HOSE CAPS (PLUGS) IN PLACE PRIOR TO DELIVERY YES/NO, GASKETS ARE SUITABLE FOR USE OR NEW YES/NO, HOSE PURGED PRIOR TO FILLING THE VESSEL YES/NO, HOSE RE-CAPED (PLUGGED) FOR STORAGE YES/NO.  DRIVER SIGNATURE:____________________ DATE:_________________

NITROGEN 
nitrogen gas
Product Information
Product TypeHUMAN PRESCRIPTION DRUG LABELItem Code (Source)NDC:42914-010
Route of AdministrationRESPIRATORY (INHALATION)DEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
NITROGEN (NITROGEN) NITROGEN99 L  in 100 L
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:42914-010-0111000000 L in 1 TANK
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved medical gas12/15/2007
Labeler - Aspen Air US Corp (790650449)
Registrant - Aspen Air US Corp (790650449)
Establishment
NameAddressID/FEIBusiness Operations
Aspen Air US Corp790650449manufacture

Revised: 1/2010
 
Aspen Air US Corp

Visit The National Library of Medicine Copyright, Privacy, Accessibility
U.S. National Library of Medicine, 8600 Rockville Pike, Bethesda, MD 20894
National Institutes of Health, Health & Human Services