NDC | 59400-001-01, 59400-001-02, 59400-001-03, 59400-001-04, 59400-005-01, 59400-005-02, 59400-005-03, 59400-005-04 |
Set ID | 5e7deef4-d5c7-4133-aa2b-e31eeb9a6d7c |
Category | HUMAN PRESCRIPTION DRUG LABEL |
Packager | BayCare Home Care, Inc. |
Generic Name | |
Product Class | |
Product Number | |
Application Number |
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Oxygen U.S.P.
UN1072
WARNING!
High Pressure Oxidizing Gas Vigorously Accelerates Combustion
Produced by Air Liquefaction
Warning!
For emergency use only when administered by properly trained personnel for oxygen deficiency and resuscitation.
Caution: RX ONLY
For other medical applications, use only as directed by a licensed practitioner. Uninterrupted use of high concentrations of oxygen for more than 5 hours, may be harmful. Do not attempt to use on patients who have stopped breathing, unless used in conjunction with resuscitative equipment.
Keep out of reach of children. Contents under pressure and can vigorously accelerate combustion. Keep oil and grease away. Do not use or store near heat or open flame and use only with pressure reducing equipment and apparatus designed for oxygen service and rated for cylinder pressure. Open valve slowly before use. Close valve after each use and when empty.
Federal law requires that this container be refilled with Gaseous Oxygen USP only by establishments registered as a Drug producer in accordance with the Federal Food, Drug and Cosmetic Act. -
Refrigerated Liquid Oxygen U.S.P.
UN1073
WARNING!
High Pressure Oxidizing Liquid and Gas Under Pressure
Vigorously Accelerates Combustion
May Explode on Ignition or Impact
Can Cause Severe Frostbite
PRODUCED BY AIR LIQUEFACTION
Caution: RX Only
Warning!
Keep oil, grease and combustibles away. Store and use with adequate ventilation. Do not get liquid in eyes, on skin, or clothing. For liquid withdrawal, wear face shield and gloves. Do not drop. Use hand truck for container movement. Avoid spills. Do not walk or roll equipment over spills. Close valve after each use and when empty.
In case of frostbite, obtain medical treatment IMMEDIATELY.
Keep out of reach of children. Contents under pressure and can vigorously accelerate combustion. Keep oil and grease away. Do not use or store near heat or open flame and use only with equipment and apparatus conditioned for oxygen service.
Use only as directed by a licensed practitioner. Uninterrupted use of high concentrations of oxygen for more than 5 hours may be harmful. Do not attempt to use on patients who have stopped breathing unless used in conjunction with resuscitative equipment.
Federal law requires that this container be refilled with Liquid Oxygen USP only by establishments registered as a Drug Producer in accordance with the Federal Food, Drug and Cosmetic Act. -
INGREDIENTS AND APPEARANCE
OXYGEN
oxygen gasProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:59400-001 Route of Administration RESPIRATORY (INHALATION) Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Oxygen (UNII: S88TT14065) (Oxygen - UNII:S88TT14065) Oxygen 210 mL in 1 L Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:59400-001-01 670 L in 1 CYLINDER; Type 0: Not a Combination Product 10/29/2013 2 NDC:59400-001-02 425 L in 1 CYLINDER; Type 0: Not a Combination Product 10/29/2013 3 NDC:59400-001-03 140 L in 1 CYLINDER; Type 0: Not a Combination Product 10/29/2013 4 NDC:59400-001-04 7760 L in 1 CYLINDER; Type 0: Not a Combination Product 10/29/2013 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved medical gas 10/29/2013 OXYGEN
oxygen liquidProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:59400-005 Route of Administration RESPIRATORY (INHALATION) Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Oxygen (UNII: S88TT14065) (Oxygen - UNII:S88TT14065) Oxygen 210 mg in 1 kg Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:59400-005-01 34168 kg in 1 DEWAR; Type 0: Not a Combination Product 11/05/2013 2 NDC:59400-005-02 37585 kg in 1 DEWAR; Type 0: Not a Combination Product 11/05/2013 3 NDC:59400-005-03 25626 kg in 1 DEWAR; Type 0: Not a Combination Product 11/05/2013 4 NDC:59400-005-04 17084 kg in 1 DEWAR; Type 0: Not a Combination Product 11/05/2013 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved medical gas 11/05/2013 Labeler - BayCare Home Care, Inc. (794046607) Registrant - BayCare Home Care, Inc. (794046607) Establishment Name Address ID/FEI Business Operations BayCare Home Care, Inc. 794046607 manufacture(59400-001, 59400-005) Establishment Name Address ID/FEI Business Operations BayCare Home Care, Inc. 832097617 manufacture(59400-001, 59400-005) Establishment Name Address ID/FEI Business Operations BayCare Home Care, Inc. 832097591 manufacture(59400-001, 59400-005)