Oxygen by ABSOLUTE AIR LLC / ABSOLUTE AIR, LLC OXYGEN gas

Oxygen by

Drug Labeling and Warnings

Oxygen by is a Prescription medication manufactured, distributed, or labeled by ABSOLUTE AIR LLC, ABSOLUTE AIR, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

PRINCIPAL DISPLAY PANEL

ABSOLUTE AIR Shipped From:

Absolute Air LLC

1305 40th Street NW

Faribault, MN 55021

763-551-5393

Certificate of Analysis

Customer Messer

Product Oxygen, USP

Time In 06/25/2022 09:02:20

Time Out 06/25/2022 09:04:27

Trailer T20

Load 1

Lot 55021-O-22-176-1-T20

Gross Weight, lbs 78500

Tare Weight, lbs 34500

Net Weight, lbs 44000

Pre-Fill Result Specification Method

Pass Pass

Post-Fill Result Specification Method

Purity, % 99.5 >= 99.0 Assay by Teledyne 3010MA Paramagnetic

H2O, ppm/V 5 N/A H2O by Teledyne 8800A Electrochemical

Odor None None Organoleptic

This product was manufactured by air liquefaction. Therefore, carbon monoxide and carbon dioxide testing is exempt under the USP compendium

Analyst: I declare that this analysis was completed within all Absolute Air policies and procedures and that the product meets Absolute Air specifications.

Signed Date/Time

Release By: I declare that this certificate is accurate, completed, and compliant with the applicable policies and procedures and that the product meets Absolute Air specifications.

Signed Date/Time

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 an MSDS.

Signed Date/Time

INGREDIENTS AND APPEARANCE

OXYGEN 
oxygen gas

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC: 82666-001
Route of Administration	RESPIRATORY (INHALATION)

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OXYGEN (UNII: S88TT14065) (OXYGEN - UNII:S88TT14065)	OXYGEN	995 mL  in 1 L

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 82666-001-01	17033 L in 1 TANK; Type 0: Not a Combination Product	06/30/2022

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
NDA	NDA217500	06/30/2022

Labeler - ABSOLUTE AIR LLC (118626491)

Establishment
Name	Address	ID/FEI	Business Operations
ABSOLUTE AIR, LLC		118626491	manufacture(82666-001)