NITROGEN- nitrogen gas 
Aspen Air U.S., LLC

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Nitrogen

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”.

NITROGEN COA

NITROGEN 
nitrogen gas
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:42914-010
Route of AdministrationRESPIRATORY (INHALATION)
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
NITROGEN (UNII: N762921K75) (NITROGEN - UNII:N762921K75) NITROGEN99 L  in 100 L
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:42914-010-0111000000 L in 1 TANK; Type 0: Not a Combination Product12/15/2007
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
NDANDA20586312/15/2007
Labeler - Aspen Air U.S., LLC (790650449)
Registrant - Aspen Air U.S., LLC (790650449)
Establishment
NameAddressID/FEIBusiness Operations
Aspen Air U.S., LLC790650449manufacture(42914-010)

Revised: 10/2021
Document Id: 926221af-8c29-430c-8163-68ddcad71835
Set id: 9c1e10e1-bbfa-4270-a923-a5b1b2bc9eae
Version: 8
Effective Time: 20211012
 
Aspen Air U.S., LLC