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| NDC | 53975-001-01, 53975-001-02, 53975-001-03, 53975-001-04, 53975-001-05 |
| Set ID | f4d291a1-7ad5-439a-b4b7-8615a4c30acb |
| Category | HUMAN PRESCRIPTION DRUG LABEL |
| Packager | Fielden Gas Products, Inc. |
| Generic Name | |
| Product Class | |
| Product Number | |
| Application Number | NDA205865 |
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Product Label
OXYGEN COMPRESSED USP
OXYGEN, COMPRESSED USP UN1072 OXYGEN 2
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 combustive material. 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.
DO NOT REMOVE THIS PRODUCT LABEL
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. © Applied Home Healthcare Equipment 2014
CAS 7782-44-7
Contents Size
113 Liters __M4
165 Liters __M6
255 Liters __ C
425 Liters __ D
680 Liters __ E
7080 Liters __ H
___ Liters __ Other
Fielden Gas Products
28300 N Wind Dr
Wright City, MO 63390
877-593-2091
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INGREDIENTS AND APPEARANCE
OXYGEN
oxygen gasProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:53975-001 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:53975-001-01 690 L in 1 CYLINDER; Type 0: Not a Combination Product 01/01/2013 2 NDC:53975-001-02 164.5 L in 1 CYLINDER; Type 0: Not a Combination Product 01/01/2013 3 NDC:53975-001-03 420 L in 1 CYLINDER; Type 0: Not a Combination Product 01/01/2013 4 NDC:53975-001-04 6900 L in 1 CYLINDER; Type 0: Not a Combination Product 01/01/2013 5 NDC:53975-001-05 8510 L in 1 CYLINDER; Type 0: Not a Combination Product 01/01/2013 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date NDA NDA205865 01/01/2013 Labeler - Fielden Gas Products, Inc. (078644672) Registrant - Fielden Gas Products, Inc. (078644672) Establishment Name Address ID/FEI Business Operations Fielden Gas Products, Inc. 078644672 manufacture(53975-001)