FDA.reportPublic FDA data

Oxygen

Manufacturer
Airway Oxygen, Inc.
Effective date
2019-10-18
Label type
HUMAN PRESCRIPTION DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 20:31:11

Label at a glance#

ProductOxygen
Active ingredientOXYGEN
Label structure2 sections

Label contents#

Full prescribing information#

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

HELIOS
OXYGEN REFRIGERATED LIQUID-USP
UN1073
BY AIR LIQUEFACTION liquid oxygen oneliquid oxygen one

PACKAGE LABEL.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 liquid oxygen twoliquid oxygen two

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
348017oxygen 99.1 % Gas for InhalationPSN1
348017oxygen 99.1 % Gas for InhalationSCD1

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
59714-012-012021-01-29C16284748780-1ba0f9c33-5e4a-a910-e053-dadaa90a0b85oxygen
59714-012-022021-01-29C16284748780-1ba0f9c33-5e4a-a910-e053-dadaa90a0b85oxygen
59714-012-032021-01-29C16284748780-1ba0f9c33-5e4a-a910-e053-dadaa90a0b85oxygen
59714-012-042021-01-29C16284748780-1ba0f9c33-5e4a-a910-e053-dadaa90a0b85oxygen
59714-012-052021-01-29C16284748780-1ba0f9c33-5e4a-a910-e053-dadaa90a0b85oxygen
59714-012-062021-01-29C16284748780-1ba0f9c33-5e4a-a910-e053-dadaa90a0b85oxygen
59714-012-072021-01-29C16284748780-1ba0f9c33-5e4a-a910-e053-dadaa90a0b85oxygen
59714-012-082021-01-29C16284748780-1ba0f9c33-5e4a-a910-e053-dadaa90a0b85oxygen
59714-012-092021-01-29C16284748780-1ba0f9c33-5e4a-a910-e053-dadaa90a0b85oxygen

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
59714-012-01Oxygen10 L in 1 DEWARGAS101
59714-012-02Oxygen20 L in 1 DEWARGAS201
59714-012-03Oxygen30 L in 1 DEWARGAS301
59714-012-04Oxygen40 L in 1 DEWARGAS401
59714-012-05Oxygen36 L in 1 DEWARGAS361
59714-012-06Oxygen46 L in 1 DEWARGAS461
59714-012-07Oxygen37 L in 1 DEWARGAS371
59714-012-08Oxygen450 L in 1 DEWARGAS4501
59714-012-09Oxygen719 L in 1 DEWARGAS7191

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
59714-012OXYGEN GAS [AIRWAY OXYGEN, INC.]1Legacy NDC, 9 package rows20191231_9af2d6f4-ba8f-5da9-e053-2995a90a3dac.zip

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 1 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
59714-01259714-012-01, 59714-012-02, 59714-012-03, 59714-012-04, 59714-012-05, 59714-012-06, 59714-012-07, 59714-012-08, 59714-012-09

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 1 matching rows.

Name, UNII, Kind table
NameUNIIKind
OXYGENS88TT14065ACTIB

Source Document#

Source XML

Orange Book application contexts#

All distinct exact application/product contexts derived from this label’s complete NDC list are paginated below.

Orange Book application contexts page 1 of 1 · 1 matching rows.

Source provenance: Browse the complete Orange Book source catalog.

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
9af2d6b3-04cc-58dd-e053-2995a90ad7a79af2d6f4-ba8f-5da9-e053-2995a90a3dac2019-10-18Exact identifier
spl id: 9af2d6b3-04cc-58dd-e053-2995a90ad7a7
spl set id: 9af2d6f4-ba8f-5da9-e053-2995a90a3dac

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.