OXYGEN gas

Drug Labeling and Warnings

Drug Details [pdf]

Principal for Oxygen Product

OXYGEN, COMPRESSED
USP
UN1072

CAS NO. 7782-44-7

WHOLE GAS TECHNOLOGIES
1544 PITTMAN AVE
Sparks, NV 89431
775-376-6017

A Division of WGT (text partially small/condensed)

WARNING: FOR EMERGENCY USE ONLY WHEN ADMINISTERED BY PROPERLY TRAINED PERSONNEL FOR OXYGEN DEFICIENCY AND RESUSCITATION. FOR ALL OTHER MEDICAL APPLICATIONS, RX REQUIRED.

CAUTION: FEDERAL LAW REQUIRES THAT THIS CONTAINER BE REFILLED WITH OXYGEN USP UN1072 ONLY BY ESTABLISHMENTS REGISTERED AS A DRUG PRODUCER IN ACCORDANCE WITH THE FEDERAL FOOD, DRUG & COSMETIC ACT.

WARNING: 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.

KEEP OUT OF REACH OF CHILDREN.

FIRST AID: IN CASE OF FROSTBITE, OBTAIN MEDICAL TREATMENT IMMEDIATELY.

WARNING:

CONTENTS UNDER HIGH PRESSURE OF OXIDIZING GAS
VIGOROUSLY ACCELERATES COMBUSTION
KEEP FREE FROM OIL AND GREASE
DO NOT USE OR STORE NEAR HEAT OR OPEN FLAME
OPEN VALVE SLOWLY
USE ONLY WITH EQUIPMENT CLEANED FOR OXYGEN SERVICE AND RATED FOR CYLINDER PRESSURE
CLOSE VALVE AFTER EACH USE AND WHEN EMPTY

CONTENTS / SIZE:

M6 — 170 Liters
C — 248 Liters
D — 415 Liters
E — 682 Liters
H — 6910 Liters
Other — ___ Liters

INGREDIENTS AND APPEARANCE

OXYGEN 
oxygen gas

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC: 84311-001
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: 84311-001-01	248 L in 1 CYLINDER; Type 0: Not a Combination Product	12/02/2024
2	NDC: 84311-001-02	415 L in 1 CYLINDER; Type 0: Not a Combination Product	12/02/2024
3	NDC: 84311-001-03	682 L in 1 CYLINDER; Type 0: Not a Combination Product	12/02/2024
4	NDC: 84311-001-04	1477 L in 1 CYLINDER; Type 0: Not a Combination Product	12/02/2009
5	NDC: 84311-001-05	6910 L in 1 CYLINDER; Type 0: Not a Combination Product	12/02/2024
6	NDC: 84311-001-06	170 L in 1 CYLINDER; Type 0: Not a Combination Product	12/02/2009

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved medical gas		12/02/2009

Labeler - Whole Gas Technologies LLC (110406866)

Establishment
Name	Address	ID/FEI	Business Operations
Whole Gas Technologies LLC		110406866	manufacture(84311-001)