MedPath

Oxygen, Refrigerated

Oxygen, Refrigerated Liquid - 010

Approved
Approval ID

a22a66f6-33bb-4b1a-b6ee-bea3e5e634d8

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Sep 3, 2025

Manufacturers
FDA

AIRGAS USA, LLC

DUNS: 078301808

Products 1

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

Oxygen, Refrigerated

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code11054-010
Application NumberNDA205840
Product Classification
M
Marketing Category
C73594
G
Generic Name
Oxygen, Refrigerated
Product Specifications
Route of AdministrationRESPIRATORY (INHALATION)
Effective DateSeptember 3, 2025
FDA Product Classification

INGREDIENTS (1)

OxygenActive
Quantity: 992 mL in 1 L
Code: S88TT14065
Classification: ACTIB

Drug Labeling Information

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LOINC: 51945-4Updated: 9/3/2025

Oxygen Refrigerated product label

OXYGEN,
REFRIGERATED
LIQUID
USP

UN1073

OXYGEN 2

DANGER: CONTAINS REFRIGERATED GAS: MAY CAUSE CRYOGENIC BURNS OR INJURY. MAY CAUSE OR INTENSIFY FIRE: OXIDIZER. COMBUSTIBLES IN CONTACT WITH LIQUID OXYGEN MAY EXPLODE ON IGNITION OR IMPACT.

Do not get into eyes, on skin, or on clothing. Keep valves and fittings free from grease and oil. Do not smoke. In case of fire: Stop leak if safe to do so. Avoid spills. Do not walk or roll equipment over spills. Use and store only outdoors or in a well ventilated place. Use only with equipment of compatible materials of construction and rated for cylinder pressure. Wear cold insulating gloves/face shield/eye protection. Do not drop. Use suitable hand truck for container movement. Close valve after each use and when empty. Use a back flow preventive device in the piping. Do not handle until all safety precautions have been read and understood. Use only with equipment cleaned for oxygen service. Keep/store away from clothing and other combustible materials. Always keep container in upright position. DO NOT change or force fit connections. Read and follow the Safety Data Sheet (SDS) before use.

FIRST AID: IF ON SKIN: Thaw frosted parts with lukewarm water. Do not rub affected area. Get immediate medical attention.

WARNING: For emergency use only when administered by properly trained personnel for oxygen deficienct and resuscitation. For all other medical applicationsRx 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 stoped breating unless used in conjunction with resuscitative equipment.

Keep out of reach of children.

Federal law required that this container be refilled with Oxyhen USP only by establishments registered as a drug manufacture in accordance with the Federal Food, Drug, and Cosmetic Act.

DO NOT REMOVE THIS PRODUCT LABEL

CAS: 7782-44-7

AIRGAS® Healthcare
an Air Liquide Company
AIRGAS USA, LLC
Radnor, PA 19087-5283

Safety Data Sheets available at www.airgas.com

84 1533
(08/16)

Airgas Ref O2

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Oxygen, Refrigerated - FDA Drug Approval Details