MedPath

Medical Oxygen Compressed

Medical Oxygen, Compressed USP

Approved
Approval ID

5e6b256f-f2c1-4384-a1fa-5235d56bc690

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Oct 19, 2022

Manufacturers
FDA

Dickinson Home Medical Equipment

DUNS: 078752225

Products 1

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

OXYGEN

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code19979-000
Application NumberNDA206023
Product Classification
M
Marketing Category
C73594
G
Generic Name
OXYGEN
Product Specifications
Route of AdministrationRESPIRATORY (INHALATION)
Effective DateOctober 19, 2022
FDA Product Classification

INGREDIENTS (1)

OXYGENActive
Quantity: 1 L in 1 L
Code: S88TT14065
Classification: ACTIB

Drug Labeling Information

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LOINC: 51945-4Updated: 11/26/2019

Package Labeling:

Label

WARNINGS SECTION

LOINC: 34071-1Updated: 11/26/2019

WARNING:

For emergency use only when administered by properly trained personnel for oxygen deficiency and resuscitation. For all other medical applications,Rx only. CAUTION: Federal law prohibits dispensing without prescription. Uninterrupted use of high concentrations of oxygen over a long duration, without monitoring its effect on oxygen content of arterial blood, may be harmful. Use only with pressure reducing equipment and apparatus designed for oxygen. Do not attempt to use on patients who have stopped breathing unless used in conjunction with resuscitative equipment.Prouduced by Air Liquefaction. WARNING: HIGH PRESSURE OXIDIZING GAS VIGOROUSLY ACCELERATES COMBUSTION. Keep oil and grease away. Open valve slowly. Store and use with adequate ventilation.Use only with equipement cleaned for oxygen service and rated for cylinder pressure. Use a back flowpreventive device in the piping. Close Valve after each use and when empty. Cylinder temperature should notexceed 52°C (125°F).Use in accordance with theMaterial Safety Data Sheet (MS DS).

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Medical Oxygen Compressed - FDA Drug Approval Details