Label: OXYGEN gas
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NDC Code(s):
72574-001-01,
72574-001-02,
72574-001-03,
72574-001-04, view more72574-001-05, 72574-001-06, 72574-001-07, 72574-001-08, 72574-001-09, 72574-001-10, 72574-001-11, 72574-001-12
- Packager: Biomedics Systems, Inc.
- Category: HUMAN PRESCRIPTION DRUG LABEL
- DEA Schedule: None
- Marketing Status: New Drug Application
Drug Label Information
Updated October 12, 2023
If you are a consumer or patient please visit this version.
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- Official Label (Printer Friendly)
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Oxygen
OXYGEN, COMPRESSED USP UN 1072 OXYGEN 2 (R-K14) XXXXXX
GCS-OXYUSP-XXX-PK500 7/12/18
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. Do not attempt to use on patients who have stopped breathing unless used in conjunction with resuscitative equipment. Produced by Air Liquefaction.DANGER: MAY CAUSE OR INTENSIFY FIRE; OXIDIZER. CONTAINS GAS UNDER PRESSURE; MAY EXPLODE IF HEATED. Do not handle until all safety precautions have been read and understood. Keep and store away from clothing and other combustible materials. Keep valves and fittings free from grease and oil. Use and store only outdoors or in a well-ventilated place. In case of fire: Stop leak if safe to do so. Use a back flow preventive device in the piping. Use only with equipment of compatible materials of construction and rated for cylinder pressure. Use only with equipment cleaned for oxygen service. Open valve slowly. Close valve after each use and when empty. Protect from sunlight when ambient temperature exceeds 52°C (125° F). Read and follow the Safety Data Sheet (SDS) before use. CAS 7782-44-7 DO NOT REMOVE THIS PRODUCT LABEL.
BioMedic Systems, Inc.
Road 176, KM 5.4, San Juan PR 00926
787-748-3868
CONTENTS:
IN CU. FT.
BMS-03
(08/18)
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INGREDIENTS AND APPEARANCE
OXYGEN
oxygen gasProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:72574-001 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:72574-001-01 113 L in 1 CYLINDER; Type 0: Not a Combination Product 07/01/2018 2 NDC:72574-001-02 170 L in 1 CYLINDER; Type 0: Not a Combination Product 07/01/2018 3 NDC:72574-001-03 255 L in 1 CYLINDER; Type 0: Not a Combination Product 07/01/2018 4 NDC:72574-001-04 425 L in 1 CYLINDER; Type 0: Not a Combination Product 07/01/2018 5 NDC:72574-001-05 566 L in 1 CYLINDER; Type 0: Not a Combination Product 07/01/2018 6 NDC:72574-001-06 679 L in 1 CYLINDER; Type 0: Not a Combination Product 07/01/2018 7 NDC:72574-001-07 1132 L in 1 CYLINDER; Type 0: Not a Combination Product 07/01/2018 8 NDC:72574-001-08 3114 L in 1 CYLINDER; Type 0: Not a Combination Product 07/01/2018 9 NDC:72574-001-09 4247 L in 1 CYLINDER; Type 0: Not a Combination Product 07/01/2018 10 NDC:72574-001-10 6228 L in 1 DEWAR; Type 0: Not a Combination Product 07/01/2018 11 NDC:72574-001-11 9540 L in 1 DEWAR; Type 0: Not a Combination Product 07/01/2018 12 NDC:72574-001-12 164793 L in 1 DEWAR; Type 0: Not a Combination Product 07/01/2018 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date NDA NDA205849 07/01/2018 Labeler - Biomedics Systems, Inc. (078435830) Establishment Name Address ID/FEI Business Operations Biomedics Systems, Inc. 078435830 manufacture(72574-001)