OXYGEN- oxygen gas 
Austin Respiratory Equipment,inc.

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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compressed oxygen


OXYGEN 
oxygen gas
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:64540-001(NDC:11390-001)
Route of AdministrationRESPIRATORY (INHALATION)
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OXYGEN (UNII: S88TT14065) (OXYGEN - UNII:S88TT14065) OXYGEN990 mL  in 1 L
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:64540-001-01170 L in 1 CYLINDER; Type 1: Convenience Kit of Co-Package07/11/2011
2NDC:64540-001-02255 L in 1 CYLINDER; Type 1: Convenience Kit of Co-Package07/11/2011
3NDC:64540-001-03450 L in 1 CYLINDER; Type 1: Convenience Kit of Co-Package07/11/2011
4NDC:64540-001-04680 L in 1 CYLINDER; Type 1: Convenience Kit of Co-Package07/11/2011
5NDC:64540-001-051738 L in 1 CYLINDER; Type 1: Convenience Kit of Co-Package07/11/2011
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved medical gas07/11/2011
Labeler - Austin Respiratory Equipment,inc. (849265483)
Registrant - Austin Respiratory Equipment,inc. (849265483)
Establishment
NameAddressID/FEIBusiness Operations
Austin Respiratory Equipment,inc.849265483relabel(64540-001)

Revised: 11/2017
Document Id: 8129b1f4-9d94-41a9-b40a-2358bd15cb21
Set id: 02b30afa-813b-41ce-8cf3-d9686ff06c77
Version: 12
Effective Time: 20171113
 
Austin Respiratory Equipment,inc.