OXYGEN GAS [UCG GEORGIA, LLC]

OXYGEN GAS [UCG GEORGIA, LLC]
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NDC 72457-003-01, 72457-003-02
Set ID 7bc13cd0-d084-1afd-e053-2991aa0a9717
Category HUMAN PRESCRIPTION DRUG LABEL
Packager UCG Georgia, LLC
Generic Name
Product Class
Product Number
Application Number NDA212314
  • PRINCIPAL DISPLAY PANEL

    UIG Universal Industrial Gases, Inc

    Certificate of Analysis

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

    Shipped From

    Taylor Data Systems

    181 E. Evans St

    Suite A

    Florence, SC 29505

    843-656-2084

    Company: Taylor Data Systems Operator: Admin

    Product: Oxygen Product Code: OX 200

    Driver: Benton Little Tractor No: 14 Trailer No: 12

    Load No: 111 Certificate No: 242 Tank No: 1000

    Time In: 10:47 AM Time Out: 10:49 AM Certification Date: 6/22/2018 10:49 AM

    Tare Weight: 10000 lbs Gross Weight: 10000 lbs Net Weight: 0 lbs

    Lot Number: TDS-161-18-O-1000-2 Produced by: Tyler

    Results Units USP/NF Specifications TDS Specifications

    Purity Pre-Fill 97.00 % >=97.00 % >=97.00 %

    Purity Post-Fill 99.00 $ >=99.00 % >=99.50 %

    Paramagnetic

    Odor None None None

    Organoleptic

    Identity Oxygen Oxygen Oxygen

    Dew Point -85.50 deg. F 0.00 deg. F

    Moisture 5.00 ppm/V <=5.00 ppm/V

    -

    Critical Analyzers Yes 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: 0.00 Gallons: 1.26 Cubic Feet: 0.00

    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: 06/22/2018

    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: 06/22/2018

    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: 06/22/2018 oxygen

  • INGREDIENTS AND APPEARANCE
    OXYGEN 
    oxygen gas
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:72457-003
    Route of AdministrationRESPIRATORY (INHALATION)
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OXYGEN (UNII: S88TT14065) (OXYGEN - UNII:S88TT14065) OXYGEN990 mL  in 1 L
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:72457-003-011.9547 L in 1 TANK; Type 0: Not a Combination Product11/01/2018
    2NDC:72457-003-0222712.47 L in 1 TANK; Type 0: Not a Combination Product11/01/2018
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    NDANDA21231411/01/2018
    Labeler - UCG Georgia, LLC (107923171)
    Establishment
    NameAddressID/FEIBusiness Operations
    UCG Georgia, LLC107923171manufacture(72457-003)

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