FDA Label for Oxygen

The following document was submitted to the FDA by the labeler of this product Airway Oxygen Inc. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.

Package Label.Principal Display Panel

LIBERATORWARNINGKEEP EQUIPMENT UPRIGHTAT ALL TIMESPRIORto using this Device read the PatientOperating Instructions Manual and Adhere toAll Warnings and Instructions.WARNING: Concentrated oxygen vigorouslyaccelerates combustion. Therefore:Keep unit away from heat, flame or sparks.Keep away from flammable materials, oil and grease.Do Not Smoke.CAUTION: Frostbite may occur on contact withcold liquid or gaseous oxygen, or frosted parts.REMEMBER:Ensure adequate ventilation for use and storage.Do not allow untrained personnel to handle or    operate this deviceThis device is not life sustaining.Rx only.If units do not disengage easily do not useforce. They may be frozen; wait untilwarm up and they shoulddisengage freely.OXIDIZER    5.1NON-FLAMMABLE GAS    2Refrigerated Liquid, USPUN1073 OXYGENProduced byAir LiquefactionM.D.D. Representative:Medical Product ServicesBorngassse 2035619 Braunfels, GermanyCE 0029CS087

Helios - Helios

HELIOS

OXYGEN
REFRIGERATED
LIQUID-USP
UN1073

BY AIR LIQUEFACTION

OXYGEN
    2


CS073

COMPANION

OXYGEN,
REFRIGERATED
LIQUID-USP                      OXYGEN
UN 1073                                 2

BY AIR LIQUEFACTION

PART No
775252
REV. C

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