OXYGEN by Aspen Air U.S., LLC OXYGEN gas

OXYGEN by

Drug Labeling and Warnings

OXYGEN by is a Prescription medication manufactured, distributed, or labeled by Aspen Air U.S., LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

OXYGEN CERTIFICATE OF ANALYSIS

THIS DOCUMENT IS THE CERTIFICATE OF ANALYSIS OF OXYGEN USP 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 99.5%

IDENTIFICATION   OXYGEN

ODOR                  NONE

CARBON DIOXIDE      LESS THAN 0.03%

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

FOR ALL OXYGEN USP INSTALLATIONS THE DRIVER SHALL ENSURE AND DOCUMENT THE FOLLOWING: HOSECAPS (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 RECAPED (PLUGGED) FOR STORAGE YES/NO. DRIVER SIGNATURE:____________________ DATE:_________________

INGREDIENTS AND APPEARANCE

OXYGEN 
oxygen gas

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC: 42914-001
Route of Administration	RESPIRATORY (INHALATION)

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OXYGEN (UNII: S88TT14065) (OXYGEN - UNII:S88TT14065)	OXYGEN	99 L  in 100 L

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 42914-001-01	10000000 L in 1 TANK; Type 0: Not a Combination Product	12/15/2007

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
NDA	NDA205862	12/15/2007

Labeler - Aspen Air U.S., LLC (790650449)

Registrant - Aspen Air U.S., LLC (790650449)

Establishment
Name	Address	ID/FEI	Business Operations
Aspen Air U.S., LLC		790650449	manufacture(42914-001)