OXYGEN GAS [PACIFIC ISLAND MEDICAL, INC.]

OXYGEN GAS [PACIFIC ISLAND MEDICAL, INC.]
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NDC	64395-0001-1, 64395-0001-2, 64395-0001-3, 64395-0001-4
Set ID	dfcc57ba-4b9f-458c-9b8a-7ab4f3e68eb2
Category	HUMAN PRESCRIPTION DRUG LABEL
Packager	Pacific Island Medical, Inc.
Generic Name
Product Class
Product Number
Application Number

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Principal for Oxygen Product

OXYGEN

COMPRESSED

USP

UN 1072

PRODUCED BY AIR LIQUIFICATION

WARNING: HIGH PRESSURE OXIDIZING GAS, VIGOROUSLY ACCELERATES COMBUSTION. NO SMOKING IN THE PRESENCE OF OXYGEN OR A FIRE MAY RESULT.

WARNING: For emergency use only when administered by properly trained personnel for oxygen deficiency and resuscitation. For all other medical applications, Rx only.

WARNING: 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 conjuction with resuscitative equipment.

WARNING: Keep oil and grease away. Use only with equipment cleaned for oxygen service and rated for cylinder pressure. Open valve slowly. Close valve after each use and when empty.

USE IN ACCORDANCE WITH MATERIAL SAFETY DATA SHEET.

DO NOT REMOVE THIS PRODUCT LABEL.

INGREDIENTS AND APPEARANCE

OXYGEN
oxygen gas

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC:64395-0001
Route of Administration	RESPIRATORY (INHALATION)

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

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:64395-0001-1	165 L in 1 CYLINDER; Type 0: Not a Combination Product	12/23/2009
2	NDC:64395-0001-2	415 L in 1 CYLINDER; Type 0: Not a Combination Product	12/23/2009
3	NDC:64395-0001-3	682 L in 1 CYLINDER; Type 0: Not a Combination Product	12/23/2009
4	NDC:64395-0001-4	3532 L in 1 CYLINDER; Type 0: Not a Combination Product	12/23/2009

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
unapproved medical gas		12/23/2009

Labeler - Pacific Island Medical, Inc. (867986994)

Name	Address	ID/FEI	Business Operations
Establishment
Pacific Island Medical, Inc.		867986994	manufacture(64395-0001)

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