Oxygen by AdaptHealth Minnesota LLC Oxygen, USP

Oxygen by

Drug Labeling and Warnings

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

Drug Details [pdf]

OXYGEN- oxygen gas 
AdaptHealth Minnesota LLC

Disclaimer: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

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Oxygen, USP

Principal for Oxygen Product

Oxygen, Compressed

USP UN1072

Produced by Air Liquefaction

Danger: May cause or intensify fire;oxidizer. Contains gas under pressure;may explode if heated.
C.A.S. NO. 7782-44-7
Do Not Remove This Product Label.
Warning: For emergency use only when administered by properly trained personnel for

oxygen deficiency and resuscitation. For all other medical applications. Rx Only. Uninterrupted

use of high concentrations of oxygen over a long duration, without monitoring its

effect on oxygen content of arterial blood, may be harmful. Do not attempt to use on

patients who have stopped breathing unless used in conjunction with resuscitative equipment.

Keep out of reach of children. Federal law requires that this container by refilled with

oxygen USP only by established registered as a drug manufacturer in accordance with

the federal Food, Drug and Cosmetic Act.

Danger: Do not handle until all safety precautions have been read and understood. Keep

and store away from clothing and other combustible materials. Keep valves and fittings

free from grease and oil. Use and store only outdoors or in a well-ventilated place. In case

of fire: Stop leak if safe to do so. Use a back flow preventive device in the piping. Use only

with equipment cleaned for oxygen service. Open valve slowly. Close valve after each use

and when empty. Protect from sunlight when ambient temperature exceeds 52ºC(125ºF)

Read and follow the Safety Data Sheet (SDS) before use.

OXYGEN 
oxygen gas

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC: 81610-001
Route of Administration	RESPIRATORY (INHALATION)

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OXYGEN (UNII: S88TT14065) (OXYGEN - UNII:S88TT14065)	OXYGEN	99 L  in 100 L

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 81610-001-01	21 L in 1 DEWAR; Type 0: Not a Combination Product	02/21/2021	09/29/2022
2	NDC: 81610-001-02	31 L in 1 DEWAR; Type 0: Not a Combination Product	02/21/2021	09/29/2022
3	NDC: 81610-001-03	36 L in 1 DEWAR; Type 0: Not a Combination Product	02/21/2021	09/29/2022
4	NDC: 81610-001-04	41 L in 1 DEWAR; Type 0: Not a Combination Product	02/21/2021	09/29/2022

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved medical gas		02/21/2021	09/29/2022

Labeler - AdaptHealth Minnesota LLC (117852242)

Establishment
Name	Address	ID/FEI	Business Operations
AdaptHealth Minnesota LLC		117852242	manufacture(81610-001)

Revised: 9/2022

Document Id: e9d68939-61bc-7b85-e053-2a95a90af64e

34391-3

Set id: bbf2f00b-fb92-7f3b-e053-2995a90a4e8b

Version: 3

Effective Time: 20220929