Label: OXYGEN gas
- NDC Code(s): 72457-003-01, 72457-003-02
- Packager: UCG Georgia, LLC
- Category: HUMAN PRESCRIPTION DRUG LABEL
- DEA Schedule: None
- Marketing Status: New Drug Application
Drug Label Information
Updated January 30, 2024
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
-
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
-
INGREDIENTS AND APPEARANCE
OXYGEN
oxygen gasProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:72457-003 Route of Administration RESPIRATORY (INHALATION) Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OXYGEN (UNII: S88TT14065) (OXYGEN - UNII:S88TT14065) OXYGEN 990 mL in 1 L Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:72457-003-01 1.9547 L in 1 TANK; Type 0: Not a Combination Product 11/01/2018 2 NDC:72457-003-02 22712.47 L in 1 TANK; Type 0: Not a Combination Product 11/01/2018 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date NDA NDA212314 11/01/2018 Labeler - UCG Georgia, LLC (107923171) Establishment Name Address ID/FEI Business Operations UCG Georgia, LLC 107923171 manufacture(72457-003) Establishment Name Address ID/FEI Business Operations UNIVERSAL INDUSTRIAL GASES, LLC 118689412 manufacture(72457-003) Establishment Name Address ID/FEI Business Operations UNIVERSAL INDUSTRIAL GASES, LLC 119179368 manufacture(72457-003)