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Oxygen

Oxygen

Approved
Approval ID

1669da72-d109-42bf-80cd-036af38b3a67

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Jan 13, 2022

Manufacturers
FDA

Red Ball Medical Supply

DUNS: 079766093

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 Code54619-0001
Product Classification
G
Generic Name
Oxygen
Product Specifications
Route of AdministrationRESPIRATORY (INHALATION)
Effective DateJanuary 13, 2022
FDA Product Classification

INGREDIENTS (1)

OXYGENActive
Quantity: 99 L in 100 L
Code: S88TT14065
Classification: ACTIB

Drug Labeling Information

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LOINC: 51945-4Updated: 5/22/2009

Principal for Oxygen Product

RepresentativeHPLabel

OXYGEN

COMPRESSED

USP

UN 1072

DANGER:

MAY CAUSE OR INTENSIFY FIRE; OXIDIZER. CONTAINS GAS UNDER PRESSURE; MAY EXPLODE IF HEATED.
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. 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. Open valve slowly. Close valve after each use and when empty. Protect from sunlight when ambient temperature exceeds 52 °c (125 °F). Read and follow the Safety Data Sheet (SDS) before use.

CAS NO: 7782-44-7

DO NOT REMOVE THIS PRODUCT LABEL.

WARNING: 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.

RepresentativeLotSticker

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Oxygen - FDA Drug Approval Details