Label: OXYGEN gas
- NDC Code(s): 58247-001-01, 58247-001-02, 58247-001-03, 58247-001-04
- Packager: Respitek Inc
- Category: HUMAN PRESCRIPTION DRUG LABEL
- DEA Schedule: None
- Marketing Status: unapproved medical gas
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Drug Label Information
Updated November 20, 2023
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PRODUCT WARNINGS AND PRECAUTIONS
WARNING: HIGH PRESSURE OXIDIZING GAS VIGOROUSLY ACCELERATES COMBUSTION. KEEP OIL AND GREASE AWAY. OPEN VALVE SLOWLY. STORE AND USE WITH ADEQUATE VENTILATION. USE ONLY WITH EQUIPMENT CLEANED FOR OXYGEN SERVICE AND RATED FOR CYLINDER PRESSURE. USE A BACK FLOW PREVENTATIVE DEVICE IN THE PIPING. CLOSE VALVE AFTER EACH USE AND WHEN EMPTY. CYLINDER TEMPERATURE SHOULD NOT EXCEED 52 C (125 F). USE IN ACCORDANCE WITH THE MATERIAL SAFETY DATA SHEET (MSDS) CAS 7782-44-7 RETURN WITH 25 PSIG. PRODUCED BY AIR LIQUEFACTION. REFILLABLE ONLY BY RESPITEK OXYGEN SERVICE.
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OXYGEN COMPRESSED LABEL
OXYGEN COMPRESSED USP UN 1072 OXYGEN-2 DO NOT REMOVE THIS PRODUCT LABEL
WARNING: FOR EMERGENCY USE ONLY WHEN ADMINISTERED BY 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.
18278 (08/04)
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INGREDIENTS AND APPEARANCE
OXYGEN
oxygen gasProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:58247-001 Route of Administration RESPIRATORY (INHALATION) Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OXYGEN (UNII: S88TT14065) (OXYGEN - UNII:S88TT14065) OXYGEN 99 L in 100 L Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:58247-001-01 248 L in 1 CYLINDER; Type 0: Not a Combination Product 01/01/1981 2 NDC:58247-001-02 426 L in 1 CYLINDER; Type 0: Not a Combination Product 01/01/1981 3 NDC:58247-001-03 671 L in 1 CYLINDER; Type 0: Not a Combination Product 01/01/1981 4 NDC:58247-001-04 3462 L in 1 CYLINDER; Type 0: Not a Combination Product 01/01/1981 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved medical gas 01/01/1981 Labeler - Respitek Inc (093592954) Registrant - Respitek Inc (093592954) Establishment Name Address ID/FEI Business Operations Respitek Inc 093592954 manufacture(58247-001)