OXYGEN GAS [GENTER HEALTHCARE, INC]

OXYGEN GAS [GENTER HEALTHCARE, INC]
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NDC 65248-001-01, 65248-001-02, 65248-001-03, 65248-001-04, 65248-001-05, 65248-001-06, 65248-001-07
Set ID f104324c-3952-491e-9d31-f8f3e00af38c
Category HUMAN PRESCRIPTION DRUG LABEL
Packager Genter Healthcare, Inc
Generic Name
Product Class
Product Number
Application Number
  • OXYGEN COMPRESSED LABEL

    OXYGEN COMPRESSED U.S.P.  UN 1072  OXYGEN-2  USE: FOR OXYGEN DEFICIENCY OR EMERGENCY RESUSCITATION WHEN USED BY PERSONNEL PROPERLY INSTRUCTED IN OXYGEN ADMINISTRATION.  CAUTION: FEDERAL LAW PROHIBITS DISPENSING WITHOUT PRESCRIPTION.  PRODUCED BY AIR LIQUEFACTION.

    WARNING: DO NOT USE HIGH CONCENTRATIONS FOR MORE THAN 5 HOURS WITHOUT 1 HOUR INTERRUPTION.  DO NOT ATTEMPT TO USE ON PATIENTS WHO HAVE STOPPED BREATHING UNLESS USED IN CONJUNCTION WITH RESUSCITATIVE EQUIPMENT.  KEEP CYLINDER, CYLINDER VALVE, ALL EQUIPMENT AND CONNECTIONS FREE OF OIL AND GREASE TO AVOID VIOLENT IGNITION.  DO NOT USE OR STORE NEAR HEAT OR OPEN FLAME.  USE ONLY WITH PRESSURE REDUCING EQUIPMENT AND APPARATUS DESIGNED FOR USE WITH OXYGEN.

    LOT NO. ___________  EXPIRATION DATE____________ LITERS__________ PART# A80024  MADE IN USA.

    hIGH PRESSURE LABEL

  • OXYGEN REFRIGERATED LIQUID LABEL

    OXYGEN REFRIGERATED LIQUID USP  UN 1073  OXYGEN-2  CONTENTS______LITERS  ALWAYS KEEP CONTAINER IN UPRIGHT POSITION.  WARNING: DO NOT CHANGE OR FORCE FIT CONNECTIONS.  EXTREMELY COLD OXIDIZING LIQUID AND GAS UNDER PRESSURE.  VIGOROUSLY ACCELERATES COMBUSTION.  NO SMOKING IN THE PRESENCE OF OXYGEN OR A FIRE MAY RESULT.  COMBUSTIBLES IN CONTACT WITH LIQUID OXYGEN MAY EXPLODE ON IGNITION OR IMPACT.  CAN CAUSE SEVERE FROSTBITE.  KEEP OIL, GREASE, AND COMBUSTIBLES AWAY.  USE ONLY WITH EQUIPMENT CLEANED FOR OXYGEN SERVICE.  STORE AND USE WITH ADEQUATE VENTILATION.  DO NOT GET LIQUID IN EYES, ON SKIN OR CLOTHING.  FOR LIQUID WITHDRAWAL WEAR FACE SHIELD AND GLOVES. DO NOT DROP.  USE SUITABLE HAND TRUCK FOR CONTAINER MOVEMENT.  AVOID SPILLS.  DO NOT WALK ON OR ROLL EQUIPMENT OVER SPILLS.  CONTAINER TEMPERATURE SHOULD NOT EXCEED 52C (125 F)  CLOSE VALVE AFTER EACH USE AND WHEN EMPTY.  USE A BACK FLOW PREVENTATIVE DEVICE IN THE PIPING.  USE IN ACCORDANCE WITH MATERIAL SAFETY DATA SHEET (MSDS)  FIRST AID: IN CASE OF FROSTBITE OBTAIN MEDICAL TREATMENT IMMEDIATELY. 

    WARNING: FOR EMERGENCY USE ONLY WHEN ADMINISTERED BY PROPERLY TRAINED PERSONNEL FOR OXYGEN DEFICIENCY AND RESUSCITATION.  FOR ALL OTHER MEDICAL APPLICATIONS Rx ONLY.  UNINTERRUPTED USE OF HIGH CONCENTRATIONS OF OXYGEN OVER A LONG DURATION WITHOUT MONITORING ITS EFFECT ON OXYGEN CONTENT OF ARTERIAL BLOOD MAY BE HARMFUL.  USE ONLY WITH PRESSURE REDUCING EQUIPMENT AND APPARATUS DESIGNED FOR OXYGEN.  DO NOT ATTEMPT TO USE ON PATIENTS WHO HAVE STOPPED BREATHING, UNLESS USED IN CONJUNCTION WITH RESUSCITATIVE EQUIPMENT.  PRODUCED BY AIR LIQUEFACTION.  DO NOT REMOVE THIS PRODUCT LABEL.  CAS NO 7782-44-7

    LIQUID LABEL

  • INGREDIENTS AND APPEARANCE
    OXYGEN 
    oxygen gas
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:65248-001
    Route of AdministrationRESPIRATORY (INHALATION)
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OXYGEN (UNII: S88TT14065) (OXYGEN - UNII:S88TT14065) OXYGEN99 L  in 100 L
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:65248-001-01248 L in 1 CYLINDER; Type 0: Not a Combination Product01/01/1993
    2NDC:65248-001-02426 L in 1 CYLINDER; Type 0: Not a Combination Product01/01/1993
    3NDC:65248-001-03671 L in 1 CYLINDER; Type 0: Not a Combination Product01/01/1993
    4NDC:65248-001-043462 L in 1 CYLINDER; Type 0: Not a Combination Product01/01/1993
    5NDC:65248-001-0518060 L in 1 DEWAR; Type 0: Not a Combination Product01/01/1993
    6NDC:65248-001-0626660 L in 1 DEWAR; Type 0: Not a Combination Product01/01/1993
    7NDC:65248-001-0730960 L in 1 DEWAR; Type 0: Not a Combination Product01/01/1993
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved medical gas01/01/1993
    Labeler - Genter Healthcare, Inc (884272121)
    Registrant - Genter Healthcare, Inc (884272121)
    Establishment
    NameAddressID/FEIBusiness Operations
    Genter Healthcare, Inc884272121manufacture(65248-001)

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