FDA Label for Oxygen
View Indications, Usage & Precautions
Oxygen Product Label
The following document was submitted to the FDA by the labeler of this product Metro Aire Ltd. 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
WARNING KEEP EQUIPMENT UPRIGHT AT ALL TIMES!
PRIOR to using this Device, read the Patient Operating Instruction Manual and Adhere to All Warnings and instructions.
WARNING: Concentrated oxygen vigorously accelerates combustion. Therefore: . Keep unit away from heat, flame or sparks. . Keep unit away from flammable materials, oil and grease. . Do Not Smoke.
WARNING: Frosbite may occur on contact with cold liquid or faseous 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 desengage easily do not use force. They may be frozen, wait until warm up and they should disengage freely. . Use of this device is restricted on commercial passenger and cargo air flights by the Federal Aviation Administration.
Refrigerated Liquid, USP UN1073 OXYGEN Produced by Air Liquefaction C E 0029 EC REP non-flammable cylinder symbol 2 oxidizer symbol 5.1
Manufactured by: CAIRE Inc. 2200 Airport Industrial Drive Suite 300 Ball Ground, GA 30107 U.S.A. M.D.D. Representative: Medical Product Services Gmbh Borngasse 20 35619 Braunfels, Germany Ref 13657677 Rev E
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