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

NITROGEN by

Drug Labeling and Warnings

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

Drug Details [pdf]

NITROGEN CERTIFICATE OF ANALYSIS

Customer

 _______                                                                     Aspen Air

________                                                                    1524 Lockwood Road

________                                                                    Billings, MT

This document is the Certificate of Analysis of nitrogen NF Lot # ______________ supplied

___ To you is a trailer delivery from our Billings Montana location.

___ Picked up by the customer listed above in their trailer

Following the Aspen Air Medical Gas procedures our location ensures that the nitrogen NF 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 nitrogen NF when the results of the product testing are entered below and the product has been delivered to a registered nitrogen NF customer. This document is in compliance with current FDA guidance.

Test                             Specification                           Results

Assay                          ≥ 99.998%                               ____

Identification                Nitrogen                                  ____

Odor                            None                                       ____

Oxygen                       ≤ 10 ppm (0.001%)                 ____

Carbon Monoxide       ≤ 10 ppm (0.001%)                 ____

*Trace oxygen analyzer          AIT-21             Model#            Teledyne 3000TAEU

*Carbon monoxide analyzer   AIT-22             Model#            Teledyne GFC 7001E

*This analyzer has been validated as an acceptable alternative to the official NF method. The validation study is available for review upon request. Odor Testing was performed using the olfactory method.    

Supplier signature: __________________________            Date: ____________

For all nitrogen NF 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 recapped (plugged) for storage                                                             Yes ___ No ___

Driver signature: ___________________                              Date: ________________

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

INGREDIENTS AND APPEARANCE

NITROGEN 
nitrogen gas

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC: 42914-010
Route of Administration	RESPIRATORY (INHALATION)

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
NITROGEN (UNII: N762921K75) (NITROGEN - UNII:N762921K75)	NITROGEN	99 L  in 100 L

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 42914-010-01	11000000 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	NDA205863	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(42914-010)