Oxygen
FDA Label NDC 59714-012

1 label section · Submitted to the FDA by Airway Oxygen, Inc. · 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 59714-012). 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.

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Package Label.Principal Display Panel

HELIOS
OXYGEN REFRIGERATED LIQUID-USP
UN1073
BY AIR LIQUEFACTION

LIBERATOR
WARNING
KEEP EQUIPMENT UPRIGHT AT ALL TIMES!
PRIOR to using this Device read the Patient Operating Instructions Manual and Adhere to All Warnings and Instructions.
WARNING: Concentrated oxygen vigorously accelerates 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 with cold 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 device.
This device is not life sustaining.
Rx only.
If units do not disengage easily do not use force. They may be frozen; wait until warm up and they should disengage freely.
Refrigerated Liquid, USP
UN073 OXYGEN
Produced by Air Liquefaction
M.D.D. Representative:
Medical Product Services
Borngasse 20
35619 Braunfels, Germany

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