Oxygen
FDA Label NDC 59714-101

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Airway Oxygen Inc for the product Oxygen (NDC 59714-101). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding package label.principal display panel, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

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 (Helios)


HELIOS

OXYGEN
REFRIGERATED
LIQUID-USP
UN1073

BY AIR LIQUEFACTION

OXYGEN
    2


CS073

Companion (Companion)

Companion (Companion)


COMPANION

OXYGEN,
REFRIGERATED
LIQUID-USP                      OXYGEN
UN 1073                                 2

BY AIR LIQUEFACTION

PART No
775252
REV. C


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