Label: NITROGEN gas

  • Category: HUMAN PRESCRIPTION DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: New Drug Application

Drug Label Information

Updated October 13, 2020

If you are a consumer or patient please visit this version.

  • PRINCIPAL DISPLAY PANEL

    UIG Universal Industrial Gases, Inc

    Certificate of Analysis

    All NF Nitrogen delivered by Universal Industrial Gases, Inc, when used in a medical application or by medical customers properly registered with the FDA, is classified as NF Nitrogen

    Shipped From

    Taylor Data Systems

    181 E. Evans St

    Suite A

    Florence, SC 29505

    843-656-2084

    Company: Taylor Data Systems Operator: Admin

    Product: Nitrogen Product Code: NI 300

    Driver: Test Driver Tractor No: 14 Trailer No: 123

    Load No: 92 Certificate No: 214 Tank No: 1100

    Time In: 12:29 PM Time Out: 2:48 PM Certification Date: 6/4/2018 2:48 PM

    Tare Weight: 10010 lbs Gross Weight: 45000 lbs Net Weight: 34990 lbs

    Lot Number: TDS-155-18-N-1100-1 Produced By: TDS

    Assay per NF requirements is by difference of O2 only

    Results Units USP/NF Specifications TDS Specifications

    Purity Pre-fill 99.9985 % >=99.9985 % >=99.9985 %

    Purity Post fill 99.9992 % >=99.00 % >=99.999 %

    Assay, by Difference

    O2 4.00 ppm/V <=1.0 % <=5.00 ppm/V

    O2-Nitrogen

    CO 4.00 ppm/V <=10.0 % <=10.00 ppm/V

    CO-Nitrogen

    Odor None None None

    Organoleptic

    Identity Nitrogen Nitrogen Nitrogen

    Dew Point -88.50 deg. F 0.00 deg. F

    Moisture 4.00 ppm/V <=5.00 ppm/V

    -

    Critical Analyzers Yes

    *The Pre-Fill is tested against UIGI specifications and a Pass indicates that the results met or exceeded the applicable specifications. The results of the Pre-Fill tests are kept on file.

    Quantity delivered to trailer: 34,990.00 Gallons: 2.04 Cubic Feet: 482966.97

    UIGI Analyst: I declare that this analysis was completed within all UIGI policy and procedures and that the product meets all UIGI specifications.

    Signed: Date: 06/04/2018

    Product Release Specialist / Released By: I declare that this certificate is accurate, complete and compliant with all applicable policies and procedures, that all pre-fill inspections including inspection of the loading hose and connections were performed following all applicable procedures, and that the product meets all UIGI specifications.

    Signed: Date: 06/04/2018

    Picked Up By: I declare that I have received the required documentation for shipment of this product and that I have the North American Emergency Response Guide or a SDS.

    Signed: Date: 06/04/2018 nitrogen

  • INGREDIENTS AND APPEARANCE
    NITROGEN 
    nitrogen gas
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:72457-005
    Route of AdministrationRESPIRATORY (INHALATION)
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    NITROGEN (UNII: N762921K75) (NITROGEN - UNII:N762921K75) NITROGEN995 mL  in 1 L
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:72457-005-011.5819 L in 1 TANK; Type 0: Not a Combination Product11/01/2018
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    NDANDA21231511/01/2018
    Labeler - UCG Georgia, LLC (107923171)
    Establishment
    NameAddressID/FEIBusiness Operations
    UCG Georgia, LLC107923171manufacture(72457-005)