OXYGEN - oxygen gas 
Genesis Respiratory Services

Disclaimer: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

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PRODUCT WARNINGS AND PRECAUTIONS

KEEP OUT OF REACH OF CHILDREN.  CONTENTS UNDER PRESSURE AND CAN VIGOROUSLY ACCELERATE COMBUSTION.  KEEP FREE FROM OIL AND GREASE.  DON NOT USE OR STORE NEAR HEAT OR OPEN FLAME AND USE ONLY WITH EQUIPMENT CONDITIONED FOR OXYGEN SERVICE. 

FEDERAL LAW REQUIRES THAT THIS CONTAINER BE REFILLED WITH OXYGEN U.S.P. ONLY BY ESTABLISHMENTS REGISTERED AS A DRUG PRODUCER IN ACCORDANCE WITH THE FEDERAL FOOD, DRUG, AND COSMETIC ACT.

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

UN INTERRUPTED USE OF HIGH CONCENTRATIONS OF OXYGEN FOR MORE THAN 5 HOURS MAY BE HARMFUL.  USE ONLY WITH PRESSURE REDUCING EQUIPMENT AND APPARATUS DESIGNED FOR OXYGEN.

LOT# __________ WT. _____________ CONTENTS_________________

OXYGEN COMPRESSED LABEL

OXYGEN COMPRESSED U.S.P. UN 1072 OXYGEN-2

WARNING HIGH PRESSURE OXIDIZING GAS. VIGOROUSLY ACCELERATES COMBUSTION PRODUCED BY AIR LIQUEFACTION

DO NOT REMOVE THIS PRODUCT LABEL

HP LABEL

OXYGEN  
oxygen gas
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:52481-2481
Route of AdministrationRESPIRATORY (INHALATION)
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OXYGEN (UNII: S88TT14065) (OXYGEN - UNII:S88TT14065) OXYGEN99.9 L  in 100 L
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:52481-2481-1164 L in 1 CYLINDER; Type 0: Not a Combination Product01/01/1977
2NDC:52481-2481-2248 L in 1 CYLINDER; Type 0: Not a Combination Product01/01/1977
3NDC:52481-2481-3415 L in 1 CYLINDER; Type 0: Not a Combination Product01/01/1977
4NDC:52481-2481-4684 L in 1 CYLINDER; Type 0: Not a Combination Product01/01/1977
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved medical gas01/01/1977
Labeler - Genesis Respiratory Services (097549687)
Registrant - Genesis Respiratory Services (097549687)
Establishment
NameAddressID/FEIBusiness Operations
Genesis Respiratory Services097549687manufacture(52481-2481)
Establishment
NameAddressID/FEIBusiness Operations
Genesis Respiratory Services059107649manufacture(52481-2481)
Establishment
NameAddressID/FEIBusiness Operations
Genesis Respiratory Services803267280manufacture(52481-2481)
Establishment
NameAddressID/FEIBusiness Operations
Genesis Respiratory Services, Inc.045717548manufacture(52481-2481)
Establishment
NameAddressID/FEIBusiness Operations
Genesis Respiratory Services961780132manufacture(52481-2481)

Revised: 12/2023
Document Id: ad236b36-ffdc-4059-80fe-63b48e9968da
Set id: 2264fffc-ddcb-4f5b-97ca-52b805a2dbd1
Version: 6
Effective Time: 20231228
 
Genesis Respiratory Services