Label: OXYGEN gas

  • Contains inactivated NDC Code(s)
    NDC Code(s):
    53828-001-01, 53828-001-02, 53828-001-03, 53828-001-04, view more
    53828-001-05, 53828-001-06, 53828-001-07, 53828-001-08, 53828-001-09, 53828-001-10, 53828-001-11, 53828-001-12, 53828-001-13, 53828-001-14
  • Packager: Rochester Welding Supply Corp.
  • Category: HUMAN PRESCRIPTION DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: unapproved medical gas

DISCLAIMER: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

Drug Label Information

Updated January 1, 2010

If you are a consumer or patient please visit this version.

  • OXYGEN COMPRESSED LABEL

    OXYGEN COMPRESSED USP - OXYGEN-2

    PRESSURE:_________ PSIG AT 70 F  SIZE: ______________  CONTENTS____________LITERS  RETURN WITH 25 PSIG.  UN 1072

    PRODUCED BY AIR LIQUEFACTION  TO BE REFILLED BY RWS AUTHORIZED FACILITY ONLY  CAS 7782-44-7  RWSLB2 REV 01/09

    BODY LABEL

  • OXYGEN COMPRESSED LABEL

    OXYGEN COMPRESSED USP - OXYGEN-2

    PRESSURE:_________ PSIG AT 70 F  SIZE: ______________  CONTENTS____________LITERS  RETURN WITH 25 PSIG.  UN 1072

    PRODUCED BY AIR LIQUEFACTION  TO BE REFILLED BY RWS AUTHORIZED FACILITY ONLY  CAS 7782-44-7 RWSLB3 REV 01/09  MADE IN THE USA

    SHOULDER LABEL

  • REFRIGERATED LIQUID LABEL

    OXYGEN REFRIGERATED LIQUID U.S.P.  UN 1073 OXYGEN-2

    GROSS WT:____ LBS. OZ. NET WT. _____________ LBS. OZ. SIZE______________ CONTENTS___________ LITERS

    OXYGEN PRODUCED BY AIR LIQUEFACTION  ALWAYS KEEP CONTAINER IN UPRIGHT POSITION.  DO NOT CHANGE OR FORCE FIT CONNECTIONS.  EXTREMELY COLD, OXIDIZING LIQUID AND GAS UNDER PRESSURE.  VIGOROUSLY ACCELERATES COMBUSTION.  COMBUSTIBLES IN CONTACT WITH LIQUID OXYGEN MAY EXPLODE ON IGNITION OR IMPACT.  CAN CAUSE SEVERE FROSTBITE.

    FOR LIQUID WITHDRAWAL WEAR FACE SHIELD AND GLOVES.  DO NOT GET LIQUID IN EYES, ON SKIN OR CLOTHING.  DO NOT DROP.  USE HAND TRUCK SPECIFICALLY DESIGNED FOR LIQUID CYLINDER MOVEMENT.  AVOID SPILLS.  DO NOT WALK OR ROLL EQUIPMENT OVER SPILLS.  USE IN ACCORDANCE WITH RWS MSDS-G046

    IN CASE OF FROSTBITE OBTAIN MEDICAL TREATMENT IMMEDIATELY.  CAS 7782-44-7  RWSLB5 REV 01/09  OXYGEN PRODUCED BY AIR LIQUEFACTION

    LIQUID LABEL

  • OXYGEN CERTIFICATE OF ANALYSIS

    LOT NUMBER____ SERIAL NUMBER________ AMOUNT_____________ INS. LBS GALS LITERS CU FT

    USP TESTS

    TEST         ID      ODOR      ASSAY

    LIMITS      OK      NONE      GREATER THAN OR EQUAL TO 99.2%

    RESULTS __      _____         _______

    FOR CUSTOMER USE TO DOCUMENT TESTS PERFORMED ON THIS VESSEL

    METHOD OF ANALYSIS IS THE PARAMAGNETIC OXYGEN ANALYZER

    MANUFACTURER __________  MODEL ________ CUSTOMER WITNESSED TESTS YES__ MO___  SUPPLIERS SIGNATURE _____________  DATE____ CUSTOMER'S SIGNATURE___________ DATE___________

    LIQUID OXYGEN DELIVERY TAG  THIS VESSEL CONTAINS OXYGEN U.S.P. (SEE REVERSE SIDE FOR TEST RESULTS) OXYGEN PRODUCED BY THE AIR LIQUEFACTION PROCESS - MEDICAL GASES

    MANUFACTURED BY ROCHESTER WELDING SUPPLY CORP 510 STATE STREET ROCHESTER, NY 14608 585-325-4730


    COA FRONT

    COA BACK

  • PRODUCT WARNINGS AND PRECAUTIONS

    KEEP ALL OIL, GREASE, AND HYDROCARBONS AWAY.  USE ONLY WITH EQUIPMENT DESIGNED AND CLEANED FOR OXYGEN SERVICE AND RATED FOR CYLINDER PRESSURE.  OPEN VALVE SLOWLY AND CLOSE AFTER EACH USE.  ALWAYS SECURE CYLINDER.  STORE AND USE WITH ADEQUATE VENTILATION.  USE A BACK FLOW PREVENTATIVE DEVICE IN THE PIPING.  CYLINDER TEMPERATURE SHOULD NOT EXCEED 52 DEGREES C (125 DEGREES F)  USE IN ACCORDANCE WITH RWS MSDS-OXY.

    WARNING: FOR EMERGENCY USE ONLY WHEN ADMINISTERED BY PROPERLY TRAINED PERSONNEL FOR OXYGEN DEFICIENCY AND RESUSCITATION.  FOR ALL OTHER MEDICAL APPLICATIONS Rx ONLY.

    WARNING: 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.

    DO NOT REMOVE THIS PRODUCT LABEL.

  • INGREDIENTS AND APPEARANCE
    OXYGEN 
    oxygen gas
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:53828-001
    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:53828-001-0190 L in 1 CYLINDER
    2NDC:53828-001-02141 L in 1 CYLINDER
    3NDC:53828-001-03234 L in 1 CYLINDER
    4NDC:53828-001-04387 L in 1 CYLINDER
    5NDC:53828-001-05643 L in 1 CYLINDER
    6NDC:53828-001-063172 L in 1 CYLINDER
    7NDC:53828-001-076400 L in 1 CYLINDER
    8NDC:53828-001-08155223 L in 1 DEWAR
    9NDC:53828-001-098522 L in 1 CYLINDER
    10NDC:53828-001-101557 L in 1 CYLINDER
    11NDC:53828-001-11153864 L in 1 DEWAR
    12NDC:53828-001-12338870 L in 1 TANK
    13NDC:53828-001-13387762 L in 1 TANK
    14NDC:53828-001-1461911 L in 1 TANK
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved medical gas01/01/1935
    Labeler - Rochester Welding Supply Corp. (013133509)
    Registrant - Rochester Welding Supply Corp. (013133509)
    Establishment
    NameAddressID/FEIBusiness Operations
    Rochester Welding Supply Corp.013133509manufacture