Label: OXYGEN- oxygen gas
view more62890-001-05, 62890-001-06
- Packager: Med-Systems, Inc.
- 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.
Updated March 25, 2014
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- Principal for Oxygen Product
OXYGEN, COMPRESSED USP
C.A.S No. 7782-44-7
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 temperatures should not exceed 52°C (125°F).
Use in accordance with Material Safety Data Sheet (MSDS).
DO NOT REMOVE THIS PRODUCT LABEL.
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
- INGREDIENTS AND APPEARANCE
Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:62890-001 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:62890-001-01 170 L in 1 CYLINDER 2 NDC:62890-001-02 415 L in 1 CYLINDER 3 NDC:62890-001-03 682 L in 1 CYLINDER 4 NDC:62890-001-04 1738 L in 1 CYLINDER 5 NDC:62890-001-05 8495 L in 1 CYLINDER 6 NDC:62890-001-06 6910 L in 1 CYLINDER Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved medical gas 03/24/2014 Labeler - Med-Systems, Inc. (058209289) Registrant - Med-Systems, Inc. (058209289) Establishment Name Address ID/FEI Business Operations Med-Systems, Inc. 058209289 manufacture(62890-001)