NDC | 10927-105-01, 10927-105-02, 10927-105-03, 10927-105-04, 10927-105-05, 10927-105-06, 10927-105-07, 10927-105-08 |
Set ID | 825d3168-17ef-4edd-a176-b5c644e42911 |
Category | HUMAN PRESCRIPTION DRUG LABEL |
Packager | PURITY CYLINDER GASES INC |
Generic Name | |
Product Class | |
Product Number | |
Application Number | NDA205767 |
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PRINCIPAL DISPLAY PANEL
OXYGEN, REFRIGERATED LIQUID USP UN1073
ALWAYS KEEP CONTAINER IN UPRIGHT POSITION.
WARNING:
USP
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
Keep out of reach of children. Federal law requires that this container be filled with oxygen USP only by establishments registered as a drug manufacturer in accordance with the Federal Food, Drug, and Cosmetic Act.
DANGER: MAY CAUSE OR INTENSIFY FIRE; OXYDIZER. CONTAINS REFRIGERATED GAS; MAY CAUSE CRYOGENIC BURNS OR INJURY. COMBUSTIBLES IN CONTACT WITH LIQUID OXYGEN MAY EXPLODE ON IGNITION OR IMPACT.
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. Wear cold insulating gloves, face shield, and eye protection. 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. DO NOT change or force fit connections. Avoid spills, Do not walk on or roll equipment over spills. Close valve after each use and when empty. Always keep container in upright position. Read and follow the Safety Data Sheet (SDS) before use.
FIRST AID: IF ON SKIN: Thaw frosted parts with lukewarm water. Do not rub affected area. Get immediate medical advice/attention. CAS: 7782-44-7
PURITY CYLINDER GASES, INC.
2580 28TH ST SW, WYOMING, MI 49519
616-532-2375
DO NOT REMOVE THIS PRODUCT LABEL. -
INGREDIENTS AND APPEARANCE
OXYGEN
oxygen liquidProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:10927-105 Route of Administration RESPIRATORY (INHALATION) Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OXYGEN (UNII: S88TT14065) (OXYGEN - UNII:S88TT14065) OXYGEN 99 in 100 L Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:10927-105-01 10 L in 1 DEWAR; Type 0: Not a Combination Product 10/20/2038 2 NDC:10927-105-02 20 L in 1 DEWAR; Type 0: Not a Combination Product 10/20/2038 3 NDC:10927-105-03 30 L in 1 DEWAR; Type 0: Not a Combination Product 10/20/2038 4 NDC:10927-105-04 40 L in 1 DEWAR; Type 0: Not a Combination Product 10/20/2038 5 NDC:10927-105-05 160 L in 1 DEWAR; Type 0: Not a Combination Product 10/20/2038 6 NDC:10927-105-06 200 L in 1 DEWAR; Type 0: Not a Combination Product 10/20/2038 7 NDC:10927-105-07 450 L in 1 DEWAR; Type 0: Not a Combination Product 10/20/2038 8 NDC:10927-105-08 719 L in 1 DEWAR; Type 0: Not a Combination Product 10/20/2038 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date NDA NDA205767 10/20/1938 Labeler - PURITY CYLINDER GASES INC (065878860) Establishment Name Address ID/FEI Business Operations PURITY CYLINDER GASES INC 006055710 manufacture(10927-105) Establishment Name Address ID/FEI Business Operations PURITY CYLINDER GASES INC 016676728 manufacture(10927-105) Establishment Name Address ID/FEI Business Operations PURITY CYLINDER GASES INC 017177031 manufacture(10927-105) Establishment Name Address ID/FEI Business Operations PURITY CYLINDER GASES INC 017198755 manufacture(10927-105) Establishment Name Address ID/FEI Business Operations PURITY CYLINDER GASES INC 085507163 manufacture(10927-105) Establishment Name Address ID/FEI Business Operations PURITY CYLINDER GASES INC 120042374 manufacture(10927-105) Establishment Name Address ID/FEI Business Operations PURITY CYLINDER GASES INC 155926434 manufacture(10927-105) Establishment Name Address ID/FEI Business Operations PURITY CYLINDER GASES INC 783309995 manufacture(10927-105)