Label: OXYGEN gas
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Contains inactivated NDC Code(s)
NDC Code(s): 59714-002-01, 59714-002-02, 59714-002-03, 59714-002-04, view more59714-002-05, 59714-002-06, 59714-002-07, 59714-002-08, 59714-002-09 - Packager: Airway Oxygen, Inc.
- Category: HUMAN PRESCRIPTION DRUG LABEL
- DEA Schedule: None
- Marketing Status: New Drug Application
Drug Label Information
Updated October 30, 2018
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- PRINCIPAL DISPLAY PANEL
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PRINCIPAL DISPLAY PANEL
LIBERATOR
WARNING
KEEP EQUIPMENT UPRIGHT AT ALL TIMES!
PRIOR to using this Device read the Patient Operating Instructions Manual and Adhere to All Warnings and Instructions.
WARNING: Concentrated oxygen vigorously accelerates combustion. Therefore:
Keep unit away from heat, flame or sparks.
Keep away from flammable materials, oil and grease.
Do Not Smoke.
CAUTION: Frostbite may occur on contact with cold liquid or gaseous oxygen, or frosted parts.
REMEMBER:
Ensure adequate ventilation for use and storage.
Do not allow untrained personnel to handle or operate this device.
This device is not life sustaining.
Rx only.
If units do not disengage easily do not use force. They may be frozen; wait until warm up and they should disengage freely.
Refrigerated Liquid, USP
UN073 OXYGEN
Produced by Air Liquefaction
M.D.D. Representative:
Medical Product Services
Borngasse 20
35619 Braunfels, Germany
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INGREDIENTS AND APPEARANCE
OXYGEN
oxygen gasProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:59714-002 Route of Administration RESPIRATORY (INHALATION) Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OXYGEN (UNII: S88TT14065) (OXYGEN - UNII:S88TT14065) OXYGEN 99.1 L in 1 L Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:59714-002-01 10 L in 1 DEWAR; Type 0: Not a Combination Product 10/21/1969 2 NDC:59714-002-02 20 L in 1 DEWAR; Type 0: Not a Combination Product 10/21/1969 3 NDC:59714-002-03 30 L in 1 DEWAR; Type 0: Not a Combination Product 10/21/1969 4 NDC:59714-002-04 40 L in 1 DEWAR; Type 0: Not a Combination Product 10/21/1969 5 NDC:59714-002-05 36 L in 1 DEWAR; Type 0: Not a Combination Product 10/21/1969 6 NDC:59714-002-06 46 L in 1 DEWAR; Type 0: Not a Combination Product 10/21/1969 7 NDC:59714-002-07 37 L in 1 DEWAR; Type 0: Not a Combination Product 10/21/1969 8 NDC:59714-002-08 450 L in 1 DEWAR; Type 0: Not a Combination Product 10/21/1969 9 NDC:59714-002-09 719 L in 1 DEWAR; Type 0: Not a Combination Product 10/21/1969 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date NDA NDA205767 10/21/1969 Labeler - Airway Oxygen, Inc. (052495116) Establishment Name Address ID/FEI Business Operations Airway Oxygen, Inc. 013045228 manufacture(59714-002) Establishment Name Address ID/FEI Business Operations Airway Oxygen, Inc. 023266680 manufacture(59714-002) Establishment Name Address ID/FEI Business Operations Airway Oxygen, Inc. 052495116 manufacture(59714-002) Establishment Name Address ID/FEI Business Operations Airway Oxygen, Inc. 075649876 manufacture(59714-002) Establishment Name Address ID/FEI Business Operations Airway Oxygen, Inc. 083171962 manufacture(59714-002) Establishment Name Address ID/FEI Business Operations Airway Oxygen, Inc. 131426942 manufacture(59714-002) Establishment Name Address ID/FEI Business Operations Airway Oxygen, Inc. 137338849 manufacture(59714-002) Establishment Name Address ID/FEI Business Operations Airway Oxygen, Inc. 163962301 manufacture(59714-002) Establishment Name Address ID/FEI Business Operations Airway Oxygen, Inc. 790153159 manufacture(59714-002) Establishment Name Address ID/FEI Business Operations Airway Oxygen, Inc. 872769971 manufacture(59714-002)
