Oxygen by Ablecare Medical, Inc. OXYGEN gas

Oxygen by

Drug Labeling and Warnings

Oxygen by is a Prescription medication manufactured, distributed, or labeled by Ablecare Medical, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Principal for Oxygen Product

OXYGEN, COMPRESSED USP
UN 1072
C.A.S No. 7782-44-7
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 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 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.

Produced by Air Liquefaction

OXYGEN,
REFRIGERATED LIQUID
USP
UN 1073
CONTENTS: LITERS

ALWAYS KEEP CONTAINER IN UPRIGHT POSITION

WARNING:
DO NOT CHANGE OR FORCE FIT CONNECTIONS
EXTREMELY COLD OXIDIZING LIQUID AND GAS UNDER PRESSURE
VIGOROUSLY ACCELERATES COMBUSTION
NO SMOKING IN THE PRESENCE OF OXYGEN OR A FIRE MAY RESULT
COMBUSTIBLES IN CONTACT WITH LIQUID OXYGEN MAY EXPLODE
ON IGNITION OR IMPACT.
CAN CAUSE SEVERE FROSTBITE.
Keep oil, grease, and combustibles away.
Use only with equipment cleaned for oxygen service.
Store and use with adequate ventilation.
Do not get liquid in eyes, on skin or clothing.
For liquid withdrawal, wear face shield and gloves.
Do not drop. Use suitable hand truck for container movement.
Container temperatures should not exceed 52 degrees C ( 125 degrees F).
Close valve after each use and when empty.
Use a back flow preventive device in the piping.
Use in accordance with the Material Safety Data Sheet (MSDS).

FIRST AID:
IN CASE OF FROSTBITE, obtain medical treatment immediately.

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. 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.

Produced by Air Liquefaction

INGREDIENTS AND APPEARANCE

OXYGEN 
oxygen gas

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC: 63699-001
Route of Administration	RESPIRATORY (INHALATION)

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Oxygen (UNII: S88TT14065) (Oxygen - UNII:S88TT14065)	Oxygen	99 L  in 100 L

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 63699-001-01	160 L in 1 CYLINDER
2	NDC: 63699-001-02	410 L in 1 CYLINDER
3	NDC: 63699-001-03	670 L in 1 CYLINDER
4	NDC: 63699-001-04	113 L in 1 CYLINDER
5	NDC: 63699-001-05	3470 L in 1 CYLINDER
6	NDC: 63699-001-06	33756 L in 1 DEWAR

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved medical gas		08/31/2012

Labeler - Ablecare Medical, Inc. (787597202)

Registrant - Ablecare Medical, Inc. (787597202)

Establishment
Name	Address	ID/FEI	Business Operations
Ablecare Medical, Inc.		787597202	manufacture(63699-001)