OXYGEN GAS [METRO AIRE LTD]

OXYGEN GAS [METRO AIRE LTD]
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NDC 70376-001-01, 70376-001-02
Set ID 9a4ac895-5b0d-4dbb-bfa5-8ff5b85ee747
Category HUMAN PRESCRIPTION DRUG LABEL
Packager Metro Aire LTD
Generic Name
Product Class
Product Number
Application Number NDA205849
  • 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 Eoxygen one

  • INGREDIENTS AND APPEARANCE
    OXYGEN 
    oxygen gas
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:70376-001
    Route of AdministrationRESPIRATORY (INHALATION)
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OXYGEN (UNII: S88TT14065) (OXYGEN - UNII:S88TT14065) OXYGEN990 L  in 1 L
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:70376-001-0145 L in 1 DEWAR; Type 0: Not a Combination Product03/04/2014
    2NDC:70376-001-0257 L in 1 DEWAR; Type 0: Not a Combination Product03/04/2014
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    NDANDA20584903/04/2014
    Labeler - Metro Aire LTD (079325342)
    Establishment
    NameAddressID/FEIBusiness Operations
    Metro Aire LTD079325342manufacture(70376-001)

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