MedPath

Oxygen

OXYGEN, REFRIGERATED LIQUID

Approved
Approval ID

3fe9967e-14c9-dcdc-7ca0-15b93341c843

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Dec 14, 2021

Manufacturers
FDA

Linde Gas & Equipment Inc.

DUNS: 805568339

Products 1

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

Oxygen

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code25373-101
Product Classification
G
Generic Name
Oxygen
Product Specifications
Route of AdministrationRESPIRATORY (INHALATION)
Effective DateNovember 9, 2017
FDA Product Classification

INGREDIENTS (1)

OxygenActive
Quantity: 99 L in 100 L
Code: S88TT14065
Classification: ACTIB

Drug Labeling Information

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LOINC: 51945-4Updated: 11/8/2017

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Linde
OXYGEN,
REFRIGERATED
LIQUID
USP
UN1073
****CAS 7782-44-7

Produced by Air Liquefaction

MEDICAL GAS
OXYGEN
2


WARNING: USE OF ADAPTORS IS PROHIBITED


WARNING: DO NOT REMOVE FITTINGS

WARNINGS SECTION

LOINC: 34071-1Updated: 11/8/2017

WARNINGS SECTION

** WARNING: For emergency use only when administered by properly trained personnel for oxygen deficiency and resuscitation. For all other 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. Use only with pressure reducing equipment and apparatus designed for oxygen. Do not attempt to use on patients who have stopped breathing, unless used in conjunction with resuscitative equipment.


**DANGER:**MAY CAUSE OR INTENSIFY FIRE; OXIDIZER.
CONTAINS REFRIGERATED GAS; MAY CAUSE CRYOGENIC BURNS OR INJURY.
COMBUSTIBLES IN CONTACT WITH LIQUID OXYGEN MAY EXPLODE ON IGNITION OR IMPACT.
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.
Wear cold insulating gloves, face shield, and eye protection.
In case of fire: Stop leak if safe to do so.
Use a back flow preventive device in the piping.
Use only with equipment of compatible materials of construction and rated for cylinder pressure.
Use only with equipment cleaned for oxygen service.
DO NOT change or force fit connections.
Avoid spills. Do not walk on or roll equipment over spills.
Close valve after each use and when empty.
Always keep container in upright position.
Read and follow the Safety Data Sheet (SDS) before use.

SPL UNCLASSIFIED SECTION

LOINC: 42229-5Updated: 11/8/2017

Un-Coded Section

FIRST AID


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

Federal law requires that this container be refilled with Oxygen USP only by establishments registered as a drug producer in accordance with the Federal Food, Drug, and Cosmetic Act. KEEP OUT OF REACH OF CHILDREN.

DO NOT REMOVE THIS LABEL.

CONTENTS:

CYLINDER TYPE

LITERS

** 160L**

[_]

121703

** 180L**

[_]

131617

** 200L**

[_]

143924

** 230L**

[_]

167855




** Distributed by:**
Linde Gas North America LLC
****200 Somerset Corporate Blvd., Suite 7000
Bridgewater, NJ 08807
866.543.3427

LG012F

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Oxygen - FDA Drug Approval Details