Label: OXYGEN gas
-
Contains inactivated NDC Code(s)
NDC Code(s): 51051-001-01, 51051-001-02, 51051-001-03, 51051-001-04 - Packager: Pure Process Medical & Scientific Gases, LLC
- 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 June 23, 2010
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
-
PRINCIPAL DISPLAY PANEL
Oxygen, Compressed
UN 1072
OXYGEN 2
Oxygen, USP
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 backflow preventive device in the piping. Close valve after each use and when empty. Cylinder temperature should not exceed 52 oC (125 oF). Use in accordance with the MSDS for this product.
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 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
Pure Process Medical and Scientific Gases, LLC
2156 W. Northwest Hwy, Ste 306
Dallas, TX 75220 Contents: ________
(Rev.15 June 2010)
-
INGREDIENTS AND APPEARANCE
OXYGEN
oxygen gasProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:51051-001 Route of Administration RESPIRATORY (INHALATION) Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Oxygen (UNII: S88TT14065) (Oxygen - UNII:S88TT14065) Oxygen 990 mL in 1 L Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:51051-001-01 566 L in 1 CYLINDER 2 NDC:51051-001-02 2265 L in 1 CYLINDER 3 NDC:51051-001-03 3539 L in 1 CYLINDER 4 NDC:51051-001-04 7107 L in 1 CYLINDER Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved medical gas 07/01/2010 Labeler - Pure Process Medical & Scientific Gases, LLC (962255514) Establishment Name Address ID/FEI Business Operations Pure Process Medical & Scientific Gases, LLC 962255514 manufacture