Label: OXYGEN gas
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Contains inactivated NDC Code(s)
NDC Code(s): 70376-001-01, 70376-001-02 - Packager: Metro Aire LTD
- Category: HUMAN PRESCRIPTION DRUG LABEL
- DEA Schedule: None
- Marketing Status: New Drug Application
Drug Label Information
Updated December 10, 2017
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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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INGREDIENTS AND APPEARANCE
OXYGEN
oxygen gasProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:70376-001 Route of Administration RESPIRATORY (INHALATION) Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OXYGEN (UNII: S88TT14065) (OXYGEN - UNII:S88TT14065) OXYGEN 990 L in 1 L Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:70376-001-01 45 L in 1 DEWAR; Type 0: Not a Combination Product 03/04/2014 2 NDC:70376-001-02 57 L in 1 DEWAR; Type 0: Not a Combination Product 03/04/2014 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date NDA NDA205849 03/04/2014 Labeler - Metro Aire LTD (079325342) Establishment Name Address ID/FEI Business Operations Metro Aire LTD 079325342 manufacture(70376-001)