NDC 80650-001 Oxygen

Oxygen

NDC Product Code 80650-001

NDC 80650-001-01

Package Description: 113 L in 1 CYLINDER

NDC 80650-001-02

Package Description: 164 L in 1 CYLINDER

NDC 80650-001-03

Package Description: 255 L in 1 CYLINDER

NDC 80650-001-04

Package Description: 425 L in 1 CYLINDER

NDC 80650-001-05

Package Description: 680 L in 1 CYLINDER

NDC 80650-001-06

Package Description: 3455 L in 1 CYLINDER

NDC 80650-001-07

Package Description: 7080 L in 1 CYLINDER

NDC Product Information

Oxygen with NDC 80650-001 is a a human prescription drug product labeled by Pur O2 Llc. The generic name of Oxygen is oxygen. The product's dosage form is gas and is administered via respiratory (inhalation) form.

Labeler Name: Pur O2 Llc

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.
  • 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: Pur O2 Llc
Labeler Code: 80650
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: 09-23-2020 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 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. Values = ‘Y’ or ‘N’.

* Please review the disclaimer below.

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

OXYGENCOMPRESSEDUSPUN 1072DANGER: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: 7782-44-7DO NOT REMOVE THIS PRODUCT LABEL.WARNING: For emergency use only when administered by properly trained personnel for oxygen deficiencyand resuscitation. For all other medical applications, Rx only.Uninterrupted use of high concentrations of oxygen over a long duration, without monitoring its effect on oxygencontent 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.

* Please review the disclaimer below.