Oxygen by UCG Georgia, LLC / UNIVERSAL INDUSTRIAL GASES, LLC OXYGEN gas

Oxygen by

Drug Labeling and Warnings

Oxygen by is a Prescription medication manufactured, distributed, or labeled by UCG Georgia, LLC, UNIVERSAL INDUSTRIAL GASES, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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 gas

Product 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)