NDC 59301-001 Oxygen

Oxygen

NDC Product Code 59301-001

NDC 59301-001-01

Package Description: 155 L in 1 CYLINDER

NDC 59301-001-02

Package Description: 240 L in 1 CYLINDER

NDC 59301-001-03

Package Description: 460 L in 1 CYLINDER

NDC 59301-001-04

Package Description: 680 L in 1 CYLINDER

NDC 59301-001-06

Package Description: 3600 L in 1 CYLINDER

NDC 59301-001-07

Package Description: 1738 L in 1 CYLINDER

NDC 59301-001-08

Package Description: 7080 L in 1 CYLINDER

NDC 59301-001-09

Package Description: 21 L in 1 DEWAR

NDC 59301-001-10

Package Description: 31 L in 1 DEWAR

NDC 59301-001-11

Package Description: 41 L in 1 DEWAR

NDC 59301-001-12

Package Description: 640 L in 1 CYLINDER

NDC Product Information

Oxygen with NDC 59301-001 is a a human prescription drug product labeled by Oxygen Support Systems Inc. The generic name of Oxygen is oxygen. The product's dosage form is gas and is administered via respiratory (inhalation) form.

Labeler Name: Oxygen Support Systems Inc

Dosage Form: Gas - Any elastic aeriform fluid in which the molecules are separated from one another and so have free paths.

Product Type: Human Prescription Drug What kind of product is this?
Indicates the type of product, such as Human Prescription Drug or Human Over the Counter Drug. This data element matches the “Document Type” field of the Structured Product Listing.

Oxygen Active Ingredient(s)

What is the Active Ingredient(s) List?
This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted.

  • OXYGEN 99 L/100L

Administration Route(s)

What are the Administration Route(s)?
The translation of the route code submitted by the firm, indicating route of administration.

  • Respiratory (inhalation) - Administration within the respiratory tract by inhaling orally or nasally for local or systemic effect.

Product Labeler Information

What is the Labeler Name?
Name of Company corresponding to the labeler code segment of the Product NDC.

Labeler Name: Oxygen Support Systems Inc
Labeler Code: 59301
Marketing Category: UNAPPROVED MEDICAL GAS - What is the Marketing Category?
Product types are broken down into several potential Marketing Categories, such as NDA/ANDA/BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.

Start Marketing Date: 08-31-2011 What is the Start Marketing Date?
This is the date that the labeler indicates was the start of its marketing of the drug product.

Listing Expiration Date: 12-31-2021 What is the Listing Expiration Date?
This is the date when the listing record will expire if not updated or certified by the product labeler.

Exclude Flag: N - NO What is the NDC Exclude Flag?
This field indicates whether the product has been removed/excluded from the NDC Directory for failure to respond to FDA"s requests for correction to deficient or non-compliant submissions ("Y"), or because the listing certification is expired ("E"), or because the listing data was inactivated by FDA ("I"). Values = "Y", "N", "E", or "I".

* Please review the disclaimer below.

Oxygen Product Label Images

Oxygen Product Labeling Information

The product labeling information includes all published material associated to a drug. Product labeling documents include information like generic names, active ingredients, ingredient strength dosage, routes of administration, appearance, usage, warnings, inactive ingredients, etc.

Product Labeling Index

Principal For Oxygen Product

OXYGEN, COMPRESSED USPUN 1072C.A.S No. 7782-44-7WARNING: HIGH PRESSURE, OXIDIZING GAS, VIGOROUSLY ACCELERATES COMBUSTION.   Keep oil
and grease away.  Open valve slowly.  Store and use with adequate ventilation. Use only with equipment cleaned for
oxygen service and rated for cylinder pressure. Use a back flow preventative device in the piping.Close valve after each use and when empty. Cylinder temperatures should
not exceed  52°C (125°F).   Use in accordance with
Material Safety Data Sheet (MSDS). 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 longduration, without monitoring its effect
on oxygen content of arterialblood, may be harmful. Use only with pressure
reducing equipmentand apparatus designed for oxygen. Do not attempt to use
onpatients who have stopped breathing, unless used in conjunctionwith
resuscitative equipment.Produced by Air Liquefaction

* Please review the disclaimer below.